Clinical trial NCT03826550: Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratoses
Lead sponsor: Encube Ethicals Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Novum Pharmaceutical Research Services
First posted: 2019-02-01
Enrollment: 655
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: proportion of patients in each treatment group with 100% clearance of all AK Lesions
timeFrame: Day 90 (30 days after completion of a 60 day treatment)
measure: Superiority of the test and reference products against the placebo
timeFrame: Day 90 (30 days after completion of a 60 day treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: San Ramon
country: United States
facility: West Coast Research
state: California
city: Coral Gables
country: United States
facility: Universal Medical and Research Center, LLC
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Lake City
country: United States
facility: Multi-Speciality Research Associates, Inc.
state: Florida
city: Miami
country: United States
facility: FXM Research
state: Florida
city: Miramar
country: United States
facility: FXM Research Miramar
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Tampa
country: United States
facility: Moore Clinical Research
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials
state: Florida
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: New Albany
country: United States
facility: DS Research
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Henderson
country: United States
facility: DTRL, Inc.
state: Nevada
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Hazleton
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: PEAK Research, LLC
state: Pennsylvania
city: Anderson
country: United States
facility: Anderson Dermatology
state: South Carolina
city: Greenville
country: United States
facility: Greenville Dermatology, LLC
state: South Carolina
city: Austin
country: United States
facility: Sirius Clinical Research, LLC
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
Study officials:
References: