<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/NCT03245385</url>
  </required_header>
  <id_info>
    <org_study_id>71542613</org_study_id>
    <nct_id>NCT03245385</nct_id>
  </id_info>
  <brief_title>Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis</brief_title>
  <official_title>An Open-Label Safety Study to Assess the Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Topical Treatment With Halobetasol Propionate 0.05% Topical Spray (Sun Pharmaceuticals Industries Limited) in Patients With Moderate to Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Pharmaceutical Industries Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novum Pharmaceutical Research Services</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Pharmaceutical Industries Limited</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>
      This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and&#xD;
      potential for adrenal suppression following topical treatment with halobetasol propionate&#xD;
      0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis.&#xD;
      At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria&#xD;
      will be enrolled into the study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and&#xD;
      potential for adrenal suppression following topical treatment with halobetasol propionate&#xD;
      0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis.&#xD;
      At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria&#xD;
      will be enrolled into the study. Patients must be overall in good health and should have a&#xD;
      current diagnosis of moderate to severe atopic dermatitis with Investigator Global Assessment&#xD;
      (IGA) score of at least 3 or 4. Patients will be stratified by age with:&#xD;
&#xD;
      Cohort 1: At least 20 patients 18 years of age and older with ≥ 25% BSA affected.&#xD;
&#xD;
      Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 25% BSA affected.&#xD;
&#xD;
      Cohort 2 will initiate enrollment once all enrolled patients in Cohort 1 have completed the&#xD;
      study and a safety analysis has been reviewed by the Medical Monitor and approved by the&#xD;
      Novum Independent Institutional Review Board (NIIRB). Sites will not begin enrollment of&#xD;
      patients in Cohort 2 until the site is notified by email that the safety analysis for Cohort&#xD;
      1 has been reviewed and approved. Each cohort will be enrolled based on the availability of&#xD;
      patients. Each cohort will be reviewed for the potential of HPA axis suppression. The Medical&#xD;
      Monitor or NIIRB may discontinue the study at any time if safety concerns are found. If 6 or&#xD;
      more patients in Cohort 1 experience HPA axis suppression, then enrollment for Cohort 1 will&#xD;
      be stopped. Cohort 2 will not be initiated if 6 or more patients enrolled in Cohort 1&#xD;
      experience HPA axis suppression or 30% or more of the final enrolled number of patients in&#xD;
      Cohort 1 experience HPA axis suppression. If 6 or more patients in Cohort 2 experience HPA&#xD;
      axis suppression, then enrollment for Cohort 2 will be stopped. If the study is stopped at&#xD;
      any time, patients currently enrolled will be contacted via phone and instructed to&#xD;
      discontinue study product immediately. Patients will be instructed to return for their next&#xD;
      scheduled visit for cortisol response testing. Sites will follow up with patients and monitor&#xD;
      for HPA axis suppression. All patients will be followed until cortisol levels are normal, as&#xD;
      defined in study protocol. Patients enrolled in the study will apply the study product twice&#xD;
      daily onto the affected skin areas for 14 days (Days 1-14), according to provided&#xD;
      instructions. .Patients will be instructed not to rub over the affected area after&#xD;
      application of spray. Each patient is expected to receive 28 doses of study product. All&#xD;
      patients will attend the clinic for the following 8 scheduled visits. Patients will apply the&#xD;
      morning dose of the study product in the clinic at each clinic visit (and evening dose on Day&#xD;
      4) and at home during non-clinic visits. A phone call will be made approximately 14 days&#xD;
      after the patient has completed dosing to follow-up on any new adverse events that may have&#xD;
      occurred. All patients will have a cortisol response test performed at screening and on Day&#xD;
      17 (at least 48 hours after last dose of study product).&#xD;
&#xD;
      The safety profile of the test product will be evaluated by analysis of reported adverse&#xD;
      events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsors decision&#xD;
  </why_stopped>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">February 5, 2018</completion_date>
  <primary_completion_date type="Actual">February 5, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open label, single treatment arm study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the IGA score at Days 4, 5, 7 and 14.</measure>
    <time_frame>14 days</time_frame>
    <description>Patients will be considered to have shown improvement in disease severity if the IGA score decreases by at least one unit from the baseline score, and will be considered a treatment success if the IGA score is either 0 (clear) or 1 (almost clear).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypothalamic Pituitary Adrenal (HPA) Axis suppression</measure>
    <time_frame>14 days</time_frame>
    <description>Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence, defined by 30 minute post- CortrosynTM injection level cortisol level of ≤18 mcg/100 mL, at the end of treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Treatment with topical halobetasol spray 0.05%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will instructed o apply halobetasol spray twice daily for 14 days and not to rub over the affected area after application of spray.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment with Halobetasol propionate 0.05% topical spray</intervention_name>
    <description>Patients will be treated with topical halobetasol 0.05% spray applied twice daily for 14 days. Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses. The maximum amount of test product applied per week will not exceed 50 g</description>
    <arm_group_label>Treatment with topical halobetasol spray 0.05%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or non-pregnant, non-lactating females:&#xD;
&#xD;
               -  Cohort 1: 18 years of age and older&#xD;
&#xD;
               -  Cohort 2: 12-16 years and 11 months of age (Cohort 2 will not begin enrollment&#xD;
                  until review and approval of safety information from Cohort 1.)&#xD;
&#xD;
          2. If female and of childbearing potential, prepared to abstain from sexual intercourse&#xD;
             or use a reliable method of contraception during the study (e.g., condom, IUD, oral,&#xD;
             transdermal or injected hormonal contraceptives). Female patients using hormonal&#xD;
             contraceptives should have been on the same product/dosing regimen for at least 28&#xD;
             days before baseline and should not change this regimen during the study.&#xD;
&#xD;
          3. Signed informed consent form that meets all criteria of current FDA regulations. For a&#xD;
             patient considered to be a minor in the state he/she lives and is enrolled, the parent&#xD;
             or legal guardian will be required to sign the consent form and the patient will sign&#xD;
             an IRB approved &quot;assent to participate&quot; form. Approved informed consent and assent&#xD;
             forms specific to each cohort will be required.&#xD;
&#xD;
          4. Patients with a definite clinical diagnosis of moderate to severe atopic dermatitis&#xD;
             with ≥ 25% BSA affected (excluding face, scalp, groin, axillae and other&#xD;
             intertriginous areas)&#xD;
&#xD;
          5. Investigator Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe).&#xD;
&#xD;
          6. Patients in Cohort 2 must weigh a minimum of 26 kg.&#xD;
&#xD;
          7. Results from a cortisol response test that are considered normal and show no evidence&#xD;
             of any abnormal HPA function or adrenal response. Patients must fulfill all of the&#xD;
             following stipulations:&#xD;
&#xD;
               1. Basal (pre Cortrosyn™ injection) cortisol concentration ≥ 5 mcg/100 mL.&#xD;
&#xD;
               2. 30-minute post-injection cortisol level is at least 7 mcg/100 mL greater than the&#xD;
                  basal level (≥ basal value + 7).&#xD;
&#xD;
               3. Post-stimulation level &gt; 18 mcg/100 mL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, nursing, planning to become pregnant during the duration of&#xD;
             the study, or if of childbearing potential and sexually active and not prepared to use&#xD;
             appropriate contraceptive methods to avoid pregnancy.&#xD;
&#xD;
          2. Mild atopic dermatitis.&#xD;
&#xD;
          3. IGA score &lt; 3.&#xD;
&#xD;
          4. Atopic dermatitis with a BSA involvement &lt; 25%.&#xD;
&#xD;
          5. Results from a cortisol response test that show evidence of any abnormal HPA function&#xD;
             or adrenal response:&#xD;
&#xD;
               1. Basal (pre CortrosynTM injection) cortisol concentration &lt; 5 mcg/100 mL.&#xD;
&#xD;
               2. 30 minute post-injection cortisol level is less than 7 mcg/100 mL greater than&#xD;
                  the basal level (&lt; basal value + 7).&#xD;
&#xD;
               3. Post-stimulation level ≤ 18 mcg/100 mL.&#xD;
&#xD;
          6. Recurrent or active cutaneous bacterial or viral infection in any treatment area at&#xD;
             baseline (i.e., clinically infected atopic dermatitis).&#xD;
&#xD;
          7. Patient has a history of atopic dermatitis that has been unresponsive to topical&#xD;
             corticosteroid therapy.&#xD;
&#xD;
          8. Any condition (i.e., sunburn, psoriasis etc.) that, in the Investigator's opinion, may&#xD;
             interfere with the clinical assessments of the signs and symptoms of atopic&#xD;
             dermatitis.&#xD;
&#xD;
          9. History of prolonged bleeding or a past diagnosis of bleeding disorders and/or history&#xD;
             of blood loss exceeding 450 mL (including blood donations) within 1 month before the&#xD;
             study.&#xD;
&#xD;
         10. Patient with poor peripheral venous access.&#xD;
&#xD;
         11. History of mastectomy or lymphatic insufficiency of the upper limb (patient is&#xD;
             eligible if blood can be taken from the arm opposite the site of surgery or&#xD;
             condition).&#xD;
&#xD;
         12. History of allergy or sensitivity to corticosteroids or history of any drug&#xD;
             hypersensitivity or intolerance that, in the opinion of the Investigator, would&#xD;
             compromise the safety of the patient or the results of the study.&#xD;
&#xD;
         13. Patient has a significant history or current evidence of chronic infectious disease,&#xD;
             system disorder, Netherton's Syndrome, uncontrolled diabetes, organ disorder or&#xD;
             insufficiency, immunosuppression (from medical treatment or disease) or other medical&#xD;
             condition that, in the Investigator's opinion, would place the study patient at undue&#xD;
             risk by participation in the study or as an unsuitable candidate for pharmacokinetic&#xD;
             blood sampling.&#xD;
&#xD;
         14. Patient is currently receiving or has received any radiation therapy or&#xD;
             anti-neoplastic agents within 3 months before baseline.&#xD;
&#xD;
         15. Use within 4 weeks before baseline of 1) oral or intravenous corticosteroids, 2)&#xD;
             UVA/UVB therapy, 3) PUVA (psoralen plus ultraviolet A therapy, 4) topical tacrolimus,&#xD;
             5) topical pimecrolimus, 6) systemic retinoids or 7) any other systemic atopic&#xD;
             dermatitis treatment.&#xD;
&#xD;
         16. Known history of hypothalamic-pituitary-adrenal axis impairment or any other&#xD;
             disturbance of the adrenal function (e.g., Cushing or Addison disease).&#xD;
&#xD;
         17. Use of tanning booths or nonprescription UV light source within 2 weeks before&#xD;
             baseline.&#xD;
&#xD;
         18. Use within 8 weeks before baseline of 1) immunomodulators or immunosuppressive&#xD;
             therapies or 2) interferon.&#xD;
&#xD;
         19. Use within 14 days before baseline of 1) systemic antibiotics, 2) calcipotriene or&#xD;
             other Vitamin D preparations, or 3) topical retinoids.&#xD;
&#xD;
         20. Patients who have used topical treatments, prescription or over the counter,&#xD;
             including:&#xD;
&#xD;
               1. Any topical atopic dermatitis therapeutic agents of any kind within the 2 weeks&#xD;
                  before baseline.&#xD;
&#xD;
               2. Any topical corticosteroids within the 2 weeks before baseline.&#xD;
&#xD;
               3. Any antibacterial, medicated and/or astringent washes, soaps, pads or&#xD;
                  moisturizers within 3 days before baseline.&#xD;
&#xD;
               4. High strength (20% or above) alpha-hydroxy acid or any kind of peel or other&#xD;
                  procedures (e.g., laser hair removal) within 30 days before baseline.&#xD;
&#xD;
               5. Any topical products (i.e., sunscreens, lotions, creams), except for bland&#xD;
                  emollient (moisturizer) within 24 hour before baseline.&#xD;
&#xD;
               6. Topical antibiotics in the treatment area within 7 days before baseline.&#xD;
&#xD;
         21. Patient has been treated within 6 months before baseline with any biological therapies&#xD;
             for atopic dermatitis.&#xD;
&#xD;
         22. Inability to understand the protocol requirements, instructions, and study-related&#xD;
             restrictions, the nature, scope, and possible consequences of the clinical study.&#xD;
&#xD;
         23. Unlikely to comply with the protocol requirements, instructions, and study-related&#xD;
             restrictions, such as uncooperative attitude, inability to return for follow-up&#xD;
             visits, and improbability of completing the clinical study.&#xD;
&#xD;
         24. Receipt of any drug as part of a research study within 30 days before baseline.&#xD;
&#xD;
         25. The patient is a member of the investigational study staff or a member of the family&#xD;
             of the investigational study staff.&#xD;
&#xD;
         26. Previous participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajinder K Jalali, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sun Pharmaceutical Industries Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Providence Clinical Research</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Havana Research Institute</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vital Pharma Research</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solutions Through Advanced Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrity Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Clinical Research, INC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regenerate Clinical Trials, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Life Medical Center and Research, INC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vista Health Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elias Research</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montana Medical Research/Elias Research Assoc.</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>49808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L&amp;C Professional Medical Research Institute</name>
      <address>
        <city>Hazleton</city>
        <state>Pennsylvania</state>
        <zip>18201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Research Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Halobetasol</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>November 2, 2021</submitted>
    <returned>November 30, 2021</returned>
    <submitted>February 3, 2022</submitted>
    <returned>February 25, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03245385
org study id: 71542613
nct id: NCT03245385
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and
      potential for adrenal suppression following topical treatment with halobetasol propionate
      0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis.
      At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria
      will be enrolled into the study
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and
      potential for adrenal suppression following topical treatment with halobetasol propionate
      0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis.
      At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria
      will be enrolled into the study. Patients must be overall in good health and should have a
      current diagnosis of moderate to severe atopic dermatitis with Investigator Global Assessment
      (IGA) score of at least 3 or 4. Patients will be stratified by age with:

      Cohort 1: At least 20 patients 18 years of age and older with ≥ 25% BSA affected.

      Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 25% BSA affected.

      Cohort 2 will initiate enrollment once all enrolled patients in Cohort 1 have completed the
      study and a safety analysis has been reviewed by the Medical Monitor and approved by the
      Novum Independent Institutional Review Board (NIIRB). Sites will not begin enrollment of
      patients in Cohort 2 until the site is notified by email that the safety analysis for Cohort
      1 has been reviewed and approved. Each cohort will be enrolled based on the availability of
      patients. Each cohort will be reviewed for the potential of HPA axis suppression. The Medical
      Monitor or NIIRB may discontinue the study at any time if safety concerns are found. If 6 or
      more patients in Cohort 1 experience HPA axis suppression, then enrollment for Cohort 1 will
      be stopped. Cohort 2 will not be initiated if 6 or more patients enrolled in Cohort 1
      experience HPA axis suppression or 30% or more of the final enrolled number of patients in
      Cohort 1 experience HPA axis suppression. If 6 or more patients in Cohort 2 experience HPA
      axis suppression, then enrollment for Cohort 2 will be stopped. If the study is stopped at
      any time, patients currently enrolled will be contacted via phone and instructed to
      discontinue study product immediately. Patients will be instructed to return for their next
      scheduled visit for cortisol response testing. Sites will follow up with patients and monitor
      for HPA axis suppression. All patients will be followed until cortisol levels are normal, as
      defined in study protocol. Patients enrolled in the study will apply the study product twice
      daily onto the affected skin areas for 14 days (Days 1-14), according to provided
      instructions. .Patients will be instructed not to rub over the affected area after
      application of spray. Each patient is expected to receive 28 doses of study product. All
      patients will attend the clinic for the following 8 scheduled visits. Patients will apply the
      morning dose of the study product in the clinic at each clinic visit (and evening dose on Day
      4) and at home during non-clinic visits. A phone call will be made approximately 14 days
      after the patient has completed dosing to follow-up on any new adverse events that may have
      occurred. All patients will have a cortisol response test performed at screening and on Day
      17 (at least 48 hours after last dose of study product).

      The safety profile of the test product will be evaluated by analysis of reported adverse
      events.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label, single treatment arm study
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in the IGA score at Days 4, 5, 7 and 14.
time frame: 14 days
description: Patients will be considered to have shown improvement in disease severity if the IGA score decreases by at least one unit from the baseline score, and will be considered a treatment success if the IGA score is either 0 (clear) or 1 (almost clear).
measure: Hypothalamic Pituitary Adrenal (HPA) Axis suppression
time frame: 14 days
description: Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence, defined by 30 minute post- CortrosynTM injection level cortisol level of ≤18 mcg/100 mL, at the end of treatment.
arm group label: Treatment with topical halobetasol spray 0.05%
arm group type: Experimental
description: Patients will instructed o apply halobetasol spray twice daily for 14 days and not to rub over the affected area after application of spray.
intervention type: Drug
intervention name: Treatment with Halobetasol propionate 0.05% topical spray
description: Patients will be treated with topical halobetasol 0.05% spray applied twice daily for 14 days. Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses. The maximum amount of test product applied per week will not exceed 50 g
arm group label: Treatment with topical halobetasol spray 0.05%
criteria: 
gender: All
minimum age: 12 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rajinder K Jalali, MD
role: Study Director
affiliation: Sun Pharmaceutical Industries Limited
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Halobetasol
submitted: November 2, 2021
returned: November 30, 2021
submitted: February 3, 2022
returned: February 25, 2022