<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03758365</url>
  </required_header>
  <id_info>
    <org_study_id>MC2-01-C4</org_study_id>
    <nct_id>NCT03758365</nct_id>
  </id_info>
  <brief_title>Evaluation of the Vasoconstriction Properties of MC2-01 Cream</brief_title>
  <official_title>A Randomized, Evaluator Blinded, Within Subject, Single-Centre Evaluation of the Vasoconstriction Properties of MC2-01 Cream, Compared to 5 Other Corticosteroids in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MC2 Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MC2 Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this trial is to compare the vasoconstriction potential&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this trial is to compare the vasoconstriction potential (skin blanching&#xD;
      effect) of MC2-01 cream with 5 comparators and MC2-01 vehicle using the human skin blanching&#xD;
      test (McKenzie-Stoughton's test).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">November 23, 2018</completion_date>
  <primary_completion_date type="Actual">November 23, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single application, intra individual comparison on mini-test sites (n=7)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Visual assessments of potential skin blanching will be made independently by 2 trained observers, according to a grading scale (0 to 4)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle</measure>
    <time_frame>Day 2</time_frame>
    <description>Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle</measure>
    <time_frame>Day 2</time_frame>
    <description>The local tolerability of the creams will be assesed using a predefined scale: 0 = No reaction; 0.5 = Only slight erythema; 1 = Only erythema; 2 = Erythema with papules or oedema; 3 = Erythema, oedema with papules, oedema with vesicle; 4 = Blisters</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Vasoconstriction</condition>
  <arm_group>
    <arm_group_label>MC2-01 Cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clobetasol propionate 0.05% lotion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single application of Clobetasol propionate 0.05%,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Betamethasone dipropionate 0.05% cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single application of Betamethasone dipropionate 0.05%,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triamcinolone acetonide 0.1% cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single application of Triamcinolone acetonide 0.1%,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrocortisone Butyrate 0.1% cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single application of Hydrocortisone Butyrate 0.1% Cream</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Desonide 0.05% cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single application of Desonide 0.05%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle cream</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single application of Vehicle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MC2-01 Cream</intervention_name>
    <description>Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
    <arm_group_label>MC2-01 Cream</arm_group_label>
    <other_name>Calcipotriol + Betamethasone dipropionate cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clobetasol Propionate 0.05% Lotion</intervention_name>
    <description>Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
    <arm_group_label>Clobetasol propionate 0.05% lotion</arm_group_label>
    <other_name>Clobex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betamethasone Dipropionate 0.05% Cream</intervention_name>
    <description>Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
    <arm_group_label>Betamethasone dipropionate 0.05% cream</arm_group_label>
    <other_name>Betamethasone Dipropionate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone Acetonide 0.1% Cream</intervention_name>
    <description>Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
    <arm_group_label>Triamcinolone acetonide 0.1% cream</arm_group_label>
    <other_name>Triamcinolone acetonide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocortisone Butyrate 0.1% Cream</intervention_name>
    <description>Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
    <arm_group_label>Hydrocortisone Butyrate 0.1% cream</arm_group_label>
    <other_name>Locoid® cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desonide 0.05% Cream</intervention_name>
    <description>Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
    <arm_group_label>Desonide 0.05% cream</arm_group_label>
    <other_name>Desowen® cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
    <arm_group_label>Vehicle cream</arm_group_label>
    <other_name>Vehicle cream</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects aged 18 years to 50 years old having signed and dated an&#xD;
             informed consent,&#xD;
&#xD;
          2. Non-smoker subjects,&#xD;
&#xD;
          3. Subjects demonstrating adequate vasoconstriction to Diprolene® cream within 15 days&#xD;
             prior to dosing (unoccluded application of Diprolene® cream for 4-6 hours must show a&#xD;
             visual score of skin blanching of at least one unit (visual scale (0-4)),&#xD;
&#xD;
          4. Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on&#xD;
             test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn),&#xD;
&#xD;
          5. Female subjects of non-childbearing potential defined as surgically sterile or&#xD;
             post-menopausal (at least one year post cessation of menses),&#xD;
&#xD;
          6. Female subjects of childbearing potential who have been, in the opinion of the&#xD;
             Investigator, using an approved method of birth control (e.g. oral contraception pill&#xD;
             or patch, intra-uterine devices, contraceptive implants or vaginal rings, condoms,&#xD;
             bilateral tubal ligation) at trial entry and agree to continue until the end of the&#xD;
             last trial visit,&#xD;
&#xD;
          7. Female subjects of childbearing potential must have a negative urine pregnancy test at&#xD;
             screening visit and at Day 1 to continue,&#xD;
&#xD;
          8. Subjects willing and able to follow all the trial procedures and complete the whole&#xD;
             trial,&#xD;
&#xD;
          9. Subjects affiliated to a social security system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are breastfeeding,&#xD;
&#xD;
          2. Use of topical corticosteroids on the test areas (forearms) within 4 weeks prior to&#xD;
             the screening phase,&#xD;
&#xD;
          3. Use of systemic drugs which may interfere with the blanching reaction including, but&#xD;
             not limited to, corticosteroids and other vasoactive drugs (nitrates derivatives,&#xD;
             antihypertensive, phenylpropanolamine, diphenhydramine, pseudo-ephedrine,&#xD;
             antihistamines, non-steroidal anti-inflammatory drug and aspirin/acetylsalicylic&#xD;
             acid), within two weeks prior to screening visit,&#xD;
&#xD;
          4. Use of any other medication would interfere with the trial results, in particular&#xD;
             topical drugs applied on the test area within two weeks prior to screening visit,&#xD;
&#xD;
          5. Subjects having a caffeine (i.e. coffee, cola, soft-drinks containing caffeine) intake&#xD;
             greater than 500mg per day (1 cup of coffee contains approximately 85mg of caffeine)&#xD;
             within one day prior to screening visit and until the end of the last visit of the&#xD;
             test phase,&#xD;
&#xD;
          6. Subjects with a history of drug or alcohol abuse/addiction.&#xD;
&#xD;
          7. Abnormal pigmentation of the skin or skin type, that could, in any way, confound&#xD;
             interpretation of the trail results (skin type V to VI on the Fitzpatrick scale),&#xD;
&#xD;
          8. Subjects with obvious difference in skin color between arms,&#xD;
&#xD;
          9. Subjects with any of the following conditions present on the test areas: viral (e.g.&#xD;
             herpes or varicella) lesions of the skin, fungal and bacterial skin infections,&#xD;
             parasitic infections, atrophic skin, and striae atrophicae, fragility of skin veins,&#xD;
             ichthyosis and ulcers,&#xD;
&#xD;
         10. Any current systemic or cutaneous disease that could in any way confound&#xD;
             interpretation of the trial results (e.g. atopic dermatitis, contact eczema, or&#xD;
             psoriasis),&#xD;
&#xD;
         11. Known or suspected hypersensitivity to any component(s) of Investigational Medical&#xD;
             Product (IMP),&#xD;
&#xD;
         12. Subjects with current participation in any other interventional clinical, based on&#xD;
             interview of the subject,&#xD;
&#xD;
         13. Subjects who have received treatment with any non-marketed drug substance (i.e. an&#xD;
             agent which has not yet been made available for clinical use following registration)&#xD;
             within the last 4 weeks prior to screening phase,&#xD;
&#xD;
         14. Previously enrolled in this clinical trial,&#xD;
&#xD;
         15. Subjects who do not accept to avoid strenuous physical activity nor alcohol intake&#xD;
             during the study.&#xD;
&#xD;
         16. In the opinion of the (sub)investigator, subjects who are unlikely to comply with the&#xD;
             Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state),&#xD;
&#xD;
         17. Subjects in close affiliation with the trial personnel (e.g. immediate family member&#xD;
             or subordinate), subjects being a member of the clinical trial personnel, or being an&#xD;
             employee of the sponsor or a Contract Research Organisation (CRO involved in the&#xD;
             trial,&#xD;
&#xD;
         18. Subjects impossible to contact in case of emergency,&#xD;
&#xD;
         19. Subjects who are in an exclusion period in the National Biomedical Research Register&#xD;
             of the French Ministry of Health at randomization,&#xD;
&#xD;
         20. Subjects under guardianship, hospitalized in a public or private institution, for a&#xD;
             reason other than the research or subject deprived of freedom.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine QUEILLE-ROUSSEL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CPCAD</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <results_first_submitted>November 21, 2019</results_first_submitted>
  <results_first_submitted_qc>January 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 9, 2020</results_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Betamethasone Valerate</mesh_term>
    <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
    <mesh_term>Betamethasone benzoate</mesh_term>
    <mesh_term>Clobetasol</mesh_term>
    <mesh_term>Desonide</mesh_term>
    <mesh_term>Hydrocortisone-17-butyrate</mesh_term>
    <mesh_term>Betamethasone sodium phosphate</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Single site study</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03758365/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03758365/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First Subject First Visit: 07-Nov-2018. Last Subject Last Visit: 23-Nov-2018</recruitment_details>
      <pre_assignment_details>The study consist of a screening period up to 15 day prior to randomization, a test period and a follow-up period.&#xD;
The study design is a within subject evaluation of the vasoconstriction properties of MC2-01 cream compared with vehicle cream and 5 other corticosteroids. All subjects received therefore a single treatment with all 7 products.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MC2-01 Cream + Comparators</title>
          <description>Single application of 7 different treatments, where different sections on the arm was randomized to the following interventions:&#xD;
- MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream&#xD;
- Clobetasol Propionate 0.05% Lotion&#xD;
- Betamethasone Dipropionate 0.05% Cream&#xD;
- Triamcinolone Acetonide 0.1% Cream&#xD;
- Hydrocortisone Butyrate 0.1% Cream&#xD;
- Desonide 0.05% Cream&#xD;
- Vehicle Cream&#xD;
to perform visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>MC2-01 Cream</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Clobetasol Propionate 0.05% Lotion</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Betamethasone Dipropionate 0.05% Cream</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Triamcinolone Acetonide 0,1% Cream</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Hydrocortisone Butyrate 0.1% Cream</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Desonide 0.05% Cream</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vehicle Cream</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All patients received all 7 types of treatments.</population>
      <group_list>
        <group group_id="B1">
          <title>MC2-01 Cream + Comparators</title>
          <description>Single application of 7 different treatments, where different sections on the arm was randomized to the following interventions:&#xD;
- MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream&#xD;
- Clobetasol Propionate 0.05% Lotion&#xD;
- Betamethasone Dipropionate 0.05% Cream&#xD;
- Triamcinolone Acetonide 0.1% Cream&#xD;
- Hydrocortisone Butyrate 0.1% Cream&#xD;
- Desonide 0.05% Cream&#xD;
- Vehicle Cream&#xD;
to perform visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>36 patients participated and they received all types of treatment. Therefore analyses of the 7 treatments arms were done for all 36 patients.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.36" spread="6.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick Skin Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>V</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle</title>
        <description>Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD.</description>
        <time_frame>Day 2</time_frame>
        <population>As the study design is a within subject evaluation of the vasoconstriction properties of MC2-01 cream compared with vehicle cream and 5 other corticosteroids, all 36 enrolled subjects received a single treatment with all 7 products.</population>
        <group_list>
          <group group_id="O1">
            <title>MC2-01 Cream + Comparators</title>
            <description>Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream&#xD;
MC2-01 Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle</title>
          <description>Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD.</description>
          <population>As the study design is a within subject evaluation of the vasoconstriction properties of MC2-01 cream compared with vehicle cream and 5 other corticosteroids, all 36 enrolled subjects received a single treatment with all 7 products.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MC2-01 Cream</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.66" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clobetasol Propionate 0.05% Lotion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.05" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Betamethasone Dipropionate 0.05% Cream</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triamcinolone Acetonide 0.1% Cream</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.92" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hydrocortisone Butyrate 0.1% Cream</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.06" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Desonide 0.05% Cream</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.11" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vehicle Cream</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle</title>
        <description>The local tolerability of the creams will be assesed using a predefined scale: 0 = No reaction; 0.5 = Only slight erythema; 1 = Only erythema; 2 = Erythema with papules or oedema; 3 = Erythema, oedema with papules, oedema with vesicle; 4 = Blisters</description>
        <time_frame>Day 2</time_frame>
        <population>The local tolerance score is presented as number of participants with observed local reaction by trial product and severity.</population>
        <group_list>
          <group group_id="O1">
            <title>MC2-01 Cream + Comparators</title>
            <description>Single application of 7 different treatments, where different sections on the arm was randomized to the following interventions:&#xD;
- MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream&#xD;
- Clobetasol Propionate 0.05% Lotion&#xD;
- Betamethasone Dipropionate 0.05% Cream&#xD;
- Triamcinolone Acetonide 0.1% Cream&#xD;
- Hydrocortisone Butyrate 0.1% Cream&#xD;
- Desonide 0.05% Cream&#xD;
- Vehicle Cream&#xD;
to perform visual evaluation of local tolerability, physical examination and safety evaluation</description>
          </group>
        </group_list>
        <measure>
          <title>Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle</title>
          <description>The local tolerability of the creams will be assesed using a predefined scale: 0 = No reaction; 0.5 = Only slight erythema; 1 = Only erythema; 2 = Erythema with papules or oedema; 3 = Erythema, oedema with papules, oedema with vesicle; 4 = Blisters</description>
          <population>The local tolerance score is presented as number of participants with observed local reaction by trial product and severity.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MC2-01 Cream</title>
              <category_list>
                <category>
                  <title>No reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only Slight reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema with papules or oedema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema, oedema with papules, oedema with vesicle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Blisters</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clobetasol Propionate 0.05% Lotion</title>
              <category_list>
                <category>
                  <title>No reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only Slight reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema with papules or oedema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema, oedema with papules, oedema with vesicle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Blisters</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Betamethasone Dipropionate 0.05% Cream</title>
              <category_list>
                <category>
                  <title>No reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only Slight reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema with papules or oedema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema, oedema with papules, oedema with vesicle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Blisters</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triamcinolone Acetonide 0.1% Cream</title>
              <category_list>
                <category>
                  <title>No reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only Slight reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema with papules or oedema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema, oedema with papules, oedema with vesicle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Blisters</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hydrocortisone Butyrate 0.1% Cream</title>
              <category_list>
                <category>
                  <title>No reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only Slight reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema with papules or oedema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema, oedema with papules, oedema with vesicle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Blisters</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Desonide 0.05% Cream</title>
              <category_list>
                <category>
                  <title>No reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only Slight reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema with papules or oedema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema, oedema with papules, oedema with vesicle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Blisters</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vehicle Cream</title>
              <category_list>
                <category>
                  <title>No reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only Slight reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Only erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema with papules or oedema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Erythema, oedema with papules, oedema with vesicle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Blisters</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected/assessed from the time the informed consent form was signed at the screening visit, which could occur up to 14 days prior to the test period, during the 2 day's test period and until the follow-up visit, 15 days following the test period, had occurred. AEs assessed as reasonably possibly related to the trial medication had to be followed until they were resolved or until the medical condition of the subject was stable.</time_frame>
      <desc>36 patients participated in the study and all patients received all 7 types of treatments. Therefore data for the 'All-Cause Mortality', 'Serious Adverse Events' and 'Other Adverse Events' fields are included and assessed for all types of medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>MC2-01 Cream</title>
          <description>Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream&#xD;
MC2-01 Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
        </group>
        <group group_id="E2">
          <title>Clobetasol Propionate 0.05% Lotion</title>
          <description>Single application of Clobetasol propionate 0.05%,&#xD;
Clobetasol Propionate 0.05% Lotion: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
        </group>
        <group group_id="E3">
          <title>Betamethasone Dipropionate 0.05% Cream</title>
          <description>Single application of Betamethasone dipropionate 0.05%,&#xD;
Betamethasone Dipropionate 0.05% Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
        </group>
        <group group_id="E4">
          <title>Triamcinolone Acetonide 0.1% Cream</title>
          <description>Single application of Triamcinolone acetonide 0.1%,&#xD;
Triamcinolone Acetonide 0.1% Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
        </group>
        <group group_id="E5">
          <title>Hydrocortisone Butyrate 0.1% Cream</title>
          <description>Single application of Hydrocortisone Butyrate 0.1% Cream&#xD;
Hydrocortisone Butyrate 0.1% Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
        </group>
        <group group_id="E6">
          <title>Desonide 0.05% Cream</title>
          <description>Single application of Desonide 0.05%&#xD;
Desonide 0.05% Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
        </group>
        <group group_id="E7">
          <title>Vehicle Cream</title>
          <description>Single application of Vehicle&#xD;
Vehicle: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The final report, the protocol and the raw date are the exclusive property of the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Birgitte Vestbjerg</name_or_title>
      <organization>MC2 Therapeutics</organization>
      <phone>+45 2077 2575</phone>
      <email>bve@mc2therapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03758365
org study id: MC2-01-C4
nct id: NCT03758365
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The objective of this trial is to compare the vasoconstriction potential
The objective of this trial is to compare the vasoconstriction potential (skin blanching
      effect) of MC2-01 cream with 5 comparators and MC2-01 vehicle using the human skin blanching
      test (McKenzie-Stoughton's test).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single application, intra individual comparison on mini-test sites (n=7)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Visual assessments of potential skin blanching will be made independently by 2 trained observers, according to a grading scale (0 to 4)
measure: Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
time frame: Day 2
description: Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD.
measure: Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
time frame: Day 2
description: The local tolerability of the creams will be assesed using a predefined scale: 0 = No reaction; 0.5 = Only slight erythema; 1 = Only erythema; 2 = Erythema with papules or oedema; 3 = Erythema, oedema with papules, oedema with vesicle; 4 = Blisters
arm group label: MC2-01 Cream
arm group type: Experimental
description: Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
arm group label: Clobetasol propionate 0.05% lotion
arm group type: Active Comparator
description: Single application of Clobetasol propionate 0.05%,
arm group label: Betamethasone dipropionate 0.05% cream
arm group type: Active Comparator
description: Single application of Betamethasone dipropionate 0.05%,
arm group label: Triamcinolone acetonide 0.1% cream
arm group type: Active Comparator
description: Single application of Triamcinolone acetonide 0.1%,
arm group label: Hydrocortisone Butyrate 0.1% cream
arm group type: Active Comparator
description: Single application of Hydrocortisone Butyrate 0.1% Cream
arm group label: Desonide 0.05% cream
arm group type: Active Comparator
description: Single application of Desonide 0.05%
arm group label: Vehicle cream
arm group type: Placebo Comparator
description: Single application of Vehicle
intervention type: Drug
intervention name: MC2-01 Cream
description: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
arm group label: MC2-01 Cream
other name: Calcipotriol + Betamethasone dipropionate cream
intervention type: Drug
intervention name: Clobetasol Propionate 0.05% Lotion
description: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
arm group label: Clobetasol propionate 0.05% lotion
other name: Clobex
intervention type: Drug
intervention name: Betamethasone Dipropionate 0.05% Cream
description: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
arm group label: Betamethasone dipropionate 0.05% cream
other name: Betamethasone Dipropionate
intervention type: Drug
intervention name: Triamcinolone Acetonide 0.1% Cream
description: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
arm group label: Triamcinolone acetonide 0.1% cream
other name: Triamcinolone acetonide
intervention type: Drug
intervention name: Hydrocortisone Butyrate 0.1% Cream
description: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
arm group label: Hydrocortisone Butyrate 0.1% cream
other name: Locoid® cream
intervention type: Drug
intervention name: Desonide 0.05% Cream
description: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
arm group label: Desonide 0.05% cream
other name: Desowen® cream
intervention type: Drug
intervention name: Vehicle
description: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
arm group label: Vehicle cream
other name: Vehicle cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine QUEILLE-ROUSSEL, MD
role: Principal Investigator
affiliation: CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie
facility: 
country: France
responsible party type: Sponsor
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Hydrocortisone
mesh term: Betamethasone
mesh term: Betamethasone Valerate
mesh term: Betamethasone-17,21-dipropionate
mesh term: Betamethasone benzoate
mesh term: Clobetasol
mesh term: Desonide
mesh term: Hydrocortisone-17-butyrate
mesh term: Betamethasone sodium phosphate
mesh term: Triamcinolone diacetate
sharing ipd: No
ipd description: Single site study
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 