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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

NCT03826550•Encube Ethicals Pvt. Ltd.

View on ClinicalTrials.gov

Summary

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

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (24)

Dermatology Trial Associates

Bryant, Arkansas, United States

West Coast Research

San Ramon, California, United States

Universal Medical and Research Center, LLC

Coral Gables, Florida, United States

Solutions Through Advanced Research, Inc.

Jacksonville, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Multi-Speciality Research Associates, Inc.

Lake City, Florida, United States

FXM Research

Miami, Florida, United States

FXM Research Miramar

Miramar, Florida, United States

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, Florida, United States

Moore Clinical Research

Tampa, Florida, United States

Key Dates

Start Date

January 12, 2018

Primary Completion Date

June 30, 2018

Completion Date

July 3, 2018

Last Updated

February 1, 2019

Enrollment

655

ACTUAL participants

Conditions

Actinic Keratoses

Interventions

Diclofenac Sodium Gel

DRUG

Solaraze 3% Topical Gel

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis

Inclusion Criteria

Exclusion Criteria

Investigation of the Effect of Lipikar Baume AP+M

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis

Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia

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Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses