Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs 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

Therapeutic Equivalence of Diclofenac Sodium Gel 3% and Solaraze ®, in the treatment of Actinic Keratosis

Study Overview

• Status: Completed
• Conditions: Actinic Keratoses
• Intervention / Treatment: Drug: Diclofenac Sodium Gel; Drug: Solaraze 3% Topical Gel; Other: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 655
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bryant, Arkansas, United States, 71011
      • Dermatology Trial Associates
  • California
    • San Ramon, California, United States, 94582
      • West Coast Research
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Universal Medical and Research Center, LLC
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research, Inc.
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Lake City, Florida, United States, 32055
      • Multi-Speciality Research Associates, Inc.
    • Miami, Florida, United States, 33175
      • FXM Research
    • Miramar, Florida, United States, 33027
      • FXM Research Miramar
    • Ormond Beach, Florida, United States, 32174
      • Ormond Medical Arts Pharmaceutical Research Center
    • Tampa, Florida, United States, 33624
      • Forward Clinical Trials
    • Tampa, Florida, United States, 33618
      • Moore Clinical Research
  • Idaho
    • Boise, Idaho, United States, 82704
      • Northwest Clinical Trials
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Ds Research
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Ds Research
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Nevada
    • Henderson, Nevada, United States, 89052
      • DTRL, Inc.
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Sterling Research Group
  • Pennsylvania
    • Hazleton, Pennsylvania, United States, 18201
      • DermDox Centers for Dermatology
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • PEAK Research, LLC
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Anderson Dermatology
    • Greenville, South Carolina, United States, 29607
      • Greenville Dermatology, LLC
  • Texas
    • Austin, Texas, United States, 78759
      • Sirius Clinical Research, LLC
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current Food and Drug Administration regulations.
2. Male or non-pregnant, non-lactating female, 18 years of age or older.
3. Diagnosis of AK with at least five and no more than ten clinically typical, visible, discrete, non-hyperkeratotic, non-hypertrophic AK lesions, each at least 4 mm in diameter, contained within a contiguous 25 cm2 treatment area on the face and/or bald scalp.
4. Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/ mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.
5. Skin pigmentation that will allow discernment of erythema.

Exclusion Criteria:

1. Females who are pregnant, lactating or planning to become pregnant during the study period.
2. Active gastrointestinal ulceration or bleeding.
3. Current evidence or history of severe renal or hepatic impairment.
4. Known allergy or hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or other excipients in the test, reference or vehicle gel.
5. Known allergy or hypersensitivity to other NSAIDs, including aspirin.
6. Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema, psoriasis, rosacea, sunburn, exfoliative dermatitis, open or recent skin wounds, active infections or other possible skin conditions on the face or bald scalp that in the Investigator's opinion would interfere with the study assessments or put the patient at risk.
7. Use of oral isotretinoin within six months before randomization.
8. Use within six months before Visit 1 on the face or bald scalp of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy.
9. Use within one month before Visit 1 on the face or bald scalp of 1) cryodestruction or chemodestruction, 2) curettage, 3) photodynamic therapy, 4) surgical excision, 5) topical 5-fluorouracil, 6) topical corticosteroids, 7) topical diclofenac, 8) topical imiquimod, 9) topical retinoids, or 10) other treatments for AK including glycolic acids or over the- counter (OTC) products containing retinol, alpha or beta hydroxy acids. The occasional use of ophthalmic, intranasal or inhaled corticosteroids (e.g., management of allergic conjunctivitis) is acceptable and not reason for exclusion. Use of inhaled corticosteroids for the management of chronic and stable conditions (e.g., persistent asthma and chronic obstructive pulmonary disease [COPD]) is acceptable as long as it has been on a stable dose for a minimum of three months before the start of the study and up to 1 mg/day.
10. Use within one month before Visit 1 of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) systemic corticosteroids or 4) cytotoxic drugs.
11. Receipt of 5-Fluorouracil or other systemic cancer chemotherapy within 6 months before Visit 1.
12. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study or put the patient at risk.
13. Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol.
14. Receipt of any drug as part of a research study within 30 days before Visit 1.
15. Employees of the Investigator or research center or their immediate family members.
16. Patients who have participated in this study previously.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Sodium Gel3%; Diclofenac Sodium Gel 3%, dosed twice daily for 60 days.	Drug: Diclofenac Sodium Gel; Twice daily for 60 days. Each patient is expected to receive 120 doses
Active Comparator: Solaraze; Solaraze Gel dosed twice daily for 60 days.	Drug: Solaraze 3% Topical Gel; Twice daily for 60 days. Each patient is expected to receive 120 doses
Placebo Comparator: Placebo; Placebo Gel dosed twice daily for 60 days.	Other: Placebo; Twice daily for 60 days. Each patient is expected to receive 120 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of patients in each treatment group with 100% clearance of all AK Lesions	Day 90 (30 days after completion of a 60 day treatment)
Superiority of the test and reference products against the placebo	Day 90 (30 days after completion of a 60 day treatment)

Collaborators and Investigators

• Sponsor: Encube Ethicals Pvt. Ltd.
• Collaborators: Novum Pharmaceutical Research Services

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 3, 2018

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: ENC16102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No