<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/NCT03826550</url>
  </required_header>
  <id_info>
    <org_study_id>ENC16102</org_study_id>
    <nct_id>NCT03826550</nct_id>
  </id_info>
  <brief_title>Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals) Compared to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the Treatment of Actinic Keratosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Encube Ethicals Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novum Pharmaceutical Research Services</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Encube Ethicals Pvt. Ltd.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Therapeutic Equivalence of Diclofenac Sodium Gel 3% and Solaraze ®, in the treatment of&#xD;
      Actinic Keratosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site&#xD;
      Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals)&#xD;
      Compared to Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the&#xD;
      Treatment of Actinic Keratosis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2018</start_date>
  <completion_date type="Actual">July 3, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>Phase 3</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>Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>All study products are blinded and provided to the patients in the same packaging.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of patients in each treatment group with 100% clearance of all AK Lesions</measure>
    <time_frame>Day 90 (30 days after completion of a 60 day treatment)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Superiority of the test and reference products against the placebo</measure>
    <time_frame>Day 90 (30 days after completion of a 60 day treatment)</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">655</enrollment>
  <condition>Actinic Keratoses</condition>
  <arm_group>
    <arm_group_label>Diclofenac Sodium Gel3%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diclofenac Sodium Gel 3%, dosed twice daily for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solaraze</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Solaraze Gel dosed twice daily for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Gel dosed twice daily for 60 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Sodium Gel</intervention_name>
    <description>Twice daily for 60 days. Each patient is expected to receive 120 doses</description>
    <arm_group_label>Diclofenac Sodium Gel3%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Solaraze 3% Topical Gel</intervention_name>
    <description>Twice daily for 60 days. Each patient is expected to receive 120 doses</description>
    <arm_group_label>Solaraze</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Twice daily for 60 days. Each patient is expected to receive 120 doses</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed Institutional Review Board (IRB)-approved informed consent form that meets all&#xD;
             criteria of current Food and Drug Administration regulations.&#xD;
&#xD;
          2. Male or non-pregnant, non-lactating female, 18 years of age or older.&#xD;
&#xD;
          3. Diagnosis of AK with at least five and no more than ten clinically typical, visible,&#xD;
             discrete, non-hyperkeratotic, non-hypertrophic AK lesions, each at least 4 mm in&#xD;
             diameter, contained within a contiguous 25 cm2 treatment area on the face and/or bald&#xD;
             scalp.&#xD;
&#xD;
          4. Females of childbearing potential must not be pregnant or lactating at Visit 1 (as&#xD;
             confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/&#xD;
             mL or equivalent units of human chorionic gonadotropin). Women of childbearing&#xD;
             potential must agree to the use of a reliable method of contraception (e.g., total&#xD;
             abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected,&#xD;
             or implanted non-hormonal or hormonal contraceptive) throughout the study. Female&#xD;
             patients using hormonal contraceptives should have been on the same product/dosing&#xD;
             regimen for at least 28 days before Visit 1 and should not change this regimen during&#xD;
             the study. A sterile sexual partner is not considered an adequate form of birth&#xD;
             control.&#xD;
&#xD;
          5. Skin pigmentation that will allow discernment of erythema.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, lactating or planning to become pregnant during the study&#xD;
             period.&#xD;
&#xD;
          2. Active gastrointestinal ulceration or bleeding.&#xD;
&#xD;
          3. Current evidence or history of severe renal or hepatic impairment.&#xD;
&#xD;
          4. Known allergy or hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol&#xD;
             monomethyl ether 359, hyaluronate sodium or other excipients in the test, reference or&#xD;
             vehicle gel.&#xD;
&#xD;
          5. Known allergy or hypersensitivity to other NSAIDs, including aspirin.&#xD;
&#xD;
          6. Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema,&#xD;
             psoriasis, rosacea, sunburn, exfoliative dermatitis, open or recent skin wounds,&#xD;
             active infections or other possible skin conditions on the face or bald scalp that in&#xD;
             the Investigator's opinion would interfere with the study assessments or put the&#xD;
             patient at risk.&#xD;
&#xD;
          7. Use of oral isotretinoin within six months before randomization.&#xD;
&#xD;
          8. Use within six months before Visit 1 on the face or bald scalp of 1) chemical peel, 2)&#xD;
             dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5)&#xD;
             UVB therapy.&#xD;
&#xD;
          9. Use within one month before Visit 1 on the face or bald scalp of 1) cryodestruction or&#xD;
             chemodestruction, 2) curettage, 3) photodynamic therapy, 4) surgical excision, 5)&#xD;
             topical 5-fluorouracil, 6) topical corticosteroids, 7) topical diclofenac, 8) topical&#xD;
             imiquimod, 9) topical retinoids, or 10) other treatments for AK including glycolic&#xD;
             acids or over the- counter (OTC) products containing retinol, alpha or beta hydroxy&#xD;
             acids. The occasional use of ophthalmic, intranasal or inhaled corticosteroids (e.g.,&#xD;
             management of allergic conjunctivitis) is acceptable and not reason for exclusion. Use&#xD;
             of inhaled corticosteroids for the management of chronic and stable conditions (e.g.,&#xD;
             persistent asthma and chronic obstructive pulmonary disease [COPD]) is acceptable as&#xD;
             long as it has been on a stable dose for a minimum of three months before the start of&#xD;
             the study and up to 1 mg/day.&#xD;
&#xD;
         10. Use within one month before Visit 1 of 1) immunomodulators or immunosuppressive&#xD;
             therapies, 2) interferon, 3) systemic corticosteroids or 4) cytotoxic drugs.&#xD;
&#xD;
         11. Receipt of 5-Fluorouracil or other systemic cancer chemotherapy within 6 months before&#xD;
             Visit 1.&#xD;
&#xD;
         12. Any condition, medical, psychological, or social, that, in the Investigator's opinion,&#xD;
             would interfere with participation in the study or put the patient at risk.&#xD;
&#xD;
         13. Inability to understand the requirements of the study and the relative information or&#xD;
             are unable or not willing to comply with the study protocol.&#xD;
&#xD;
         14. Receipt of any drug as part of a research study within 30 days before Visit 1.&#xD;
&#xD;
         15. Employees of the Investigator or research center or their immediate family members.&#xD;
&#xD;
         16. Patients who have participated in this study previously.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermatology Trial Associates</name>
      <address>
        <city>Bryant</city>
        <state>Arkansas</state>
        <zip>71011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Coast Research</name>
      <address>
        <city>San Ramon</city>
        <state>California</state>
        <zip>94582</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universal Medical and Research Center, LLC</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solutions Through Advanced Research, Inc.</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Awareness, Inc.</name>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multi-Speciality Research Associates, Inc.</name>
      <address>
        <city>Lake City</city>
        <state>Florida</state>
        <zip>32055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FXM Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FXM Research Miramar</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ormond Medical Arts Pharmaceutical Research Center</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moore Clinical Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forward Clinical Trials</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33624</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Trials</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>82704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Research</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Research</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Clinical Study Center</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DTRL, Inc.</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Consulting Services</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sterling Research Group</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermDox Centers for Dermatology</name>
      <address>
        <city>Hazleton</city>
        <state>Pennsylvania</state>
        <zip>18201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PEAK Research, LLC</name>
      <address>
        <city>Upper Saint Clair</city>
        <state>Pennsylvania</state>
        <zip>15241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anderson Dermatology</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Dermatology, LLC</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sirius Clinical Research, LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Research of Hampton Roads, Inc.</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 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>Keratosis, Actinic</mesh_term>
    <mesh_term>Keratosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 31, 2019</submitted>
    <returned>June 24, 2019</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/NCT03826550
org study id: ENC16102
nct id: NCT03826550
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Therapeutic Equivalence of Diclofenac Sodium Gel 3% and Solaraze ®, in the treatment of
      Actinic Keratosis
A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site
      Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals)
      Compared to Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the
      Treatment of Actinic Keratosis
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: All study products are blinded and provided to the patients in the same packaging.
measure: proportion of patients in each treatment group with 100% clearance of all AK Lesions
time frame: Day 90 (30 days after completion of a 60 day treatment)
measure: Superiority of the test and reference products against the placebo
time frame: Day 90 (30 days after completion of a 60 day treatment)
arm group label: Diclofenac Sodium Gel3%
arm group type: Experimental
description: Diclofenac Sodium Gel 3%, dosed twice daily for 60 days.
arm group label: Solaraze
arm group type: Active Comparator
description: Solaraze Gel dosed twice daily for 60 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Gel dosed twice daily for 60 days.
intervention type: Drug
intervention name: Diclofenac Sodium Gel
description: Twice daily for 60 days. Each patient is expected to receive 120 doses
arm group label: Diclofenac Sodium Gel3%
intervention type: Drug
intervention name: Solaraze 3% Topical Gel
description: Twice daily for 60 days. Each patient is expected to receive 120 doses
arm group label: Solaraze
intervention type: Other
intervention name: Placebo
description: Twice daily for 60 days. Each patient is expected to receive 120 doses
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Keratosis, Actinic
mesh term: Keratosis
mesh term: Diclofenac
sharing ipd: No
submitted: May 31, 2019
returned: June 24, 2019