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

NCT03826550 | Completed Phase 3 FDA Drug

• 1 other identifier: ENC16102
• Study Type: interventional
• Target: 655
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

Diclofenac Sodium Gel3%

EXPERIMENTAL

Diclofenac Sodium Gel 3%, dosed twice daily for 60 days.

Drug: Diclofenac Sodium Gel

Solaraze

ACTIVE COMPARATOR

Solaraze Gel dosed twice daily for 60 days.

Drug: Solaraze 3% Topical Gel

Placebo

PLACEBO COMPARATOR

Placebo Gel dosed twice daily for 60 days.

Other: Placebo

Interventions

Diclofenac Sodium Gel DRUG

Twice daily for 60 days. Each patient is expected to receive 120 doses

Diclofenac Sodium Gel3%

Solaraze 3% Topical Gel DRUG

Twice daily for 60 days. Each patient is expected to receive 120 doses

Solaraze

Placebo OTHER

Twice daily for 60 days. Each patient is expected to receive 120 doses

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current Food and Drug Administration regulations.
• Male or non-pregnant, non-lactating female, 18 years of age or older.
• 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.
• 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.
• Skin pigmentation that will allow discernment of erythema.

You may not qualify if:

• Females who are pregnant, lactating or planning to become pregnant during the study period.
• Active gastrointestinal ulceration or bleeding.
• Current evidence or history of severe renal or hepatic impairment.
• 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.
• Known allergy or hypersensitivity to other NSAIDs, including aspirin.
• 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.
• Use of oral isotretinoin within six months before randomization.
• 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.
• Use within one month before Visit 1 of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) systemic corticosteroids or 4) cytotoxic drugs.
• Receipt of 5-Fluorouracil or other systemic cancer chemotherapy within 6 months before Visit 1.
• 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.
• Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol.
• Receipt of any drug as part of a research study within 30 days before Visit 1.
• Employees of the Investigator or research center or their immediate family members.
• Patients who have participated in this study previously.

Sponsors & Collaborators

• Encube Ethicals Pvt. Ltd.: lead
• Novum Pharmaceutical Research Services: collaborator

Study Sites (24)

Dermatology Trial Associates

Bryant, Arkansas, 71011, United States

Location

West Coast Research

San Ramon, California, 94582, United States

Location

Universal Medical and Research Center, LLC

Coral Gables, Florida, 33134, United States

Location

Solutions Through Advanced Research, Inc.

Jacksonville, Florida, 32256, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Multi-Speciality Research Associates, Inc.

Lake City, Florida, 32055, United States

Location

FXM Research

Miami, Florida, 33175, United States

Location

FXM Research Miramar

Miramar, Florida, 33027, United States

Location

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, Florida, 32174, United States

Location

Moore Clinical Research

Tampa, Florida, 33618, United States

Location

Forward Clinical Trials

Tampa, Florida, 33624, United States

Location

Northwest Clinical Trials

Boise, Idaho, 82704, United States

Location

DS Research

New Albany, Indiana, 47150, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

DTRL, Inc.

Henderson, Nevada, 89052, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Sterling Research Group

Cincinnati, Ohio, 45246, United States

Location

DermDox Centers for Dermatology

Hazleton, Pennsylvania, 18201, United States

Location

PEAK Research, LLC

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Anderson Dermatology

Anderson, South Carolina, 29621, United States

Location

Greenville Dermatology, LLC

Greenville, South Carolina, 29607, United States

Location

Sirius Clinical Research, LLC

Austin, Texas, 78759, United States

Location

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Diclofenac; Gels

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study products are blinded and provided to the patients in the same packaging.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 1, 2019
• Study Start: January 12, 2018
• Primary Completion: June 30, 2018
• Study Completion: July 3, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)