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

Actinic Keratoses Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826550
• Other study ID #: ENC16102
• Status: Completed
• Phase: Phase 3
• Start date: January 12, 2018
• Est. completion date: July 3, 2018

Study information

• Verified date: January 2019
• Source: Encube Ethicals Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. completion date: July 3, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Diclofenac Sodium Gel
Twice daily for 60 days. Each patient is expected to receive 120 doses
• Solaraze 3% Topical Gel
Twice daily for 60 days. Each patient is expected to receive 120 doses

Other:
• Placebo
Twice daily for 60 days. Each patient is expected to receive 120 doses

Locations

Country	Name	City	State
United States	Anderson Dermatology	Anderson	South Carolina
United States	Sirius Clinical Research, LLC	Austin	Texas
United States	Northwest Clinical Trials	Boise	Idaho
United States	Dermatology Trial Associates	Bryant	Arkansas
United States	Sterling Research Group	Cincinnati	Ohio
United States	Universal Medical and Research Center, LLC	Coral Gables	Florida
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Greenville Dermatology, LLC	Greenville	South Carolina
United States	DermDox Centers for Dermatology	Hazleton	Pennsylvania
United States	DTRL, Inc.	Henderson	Nevada
United States	Dermatology Consulting Services	High Point	North Carolina
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	DS Research	Louisville	Kentucky
United States	FXM Research	Miami	Florida
United States	FXM Research Miramar	Miramar	Florida
United States	DS Research	New Albany	Indiana
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Ormond Medical Arts Pharmaceutical Research Center	Ormond Beach	Florida
United States	West Coast Research	San Ramon	California
United States	Forward Clinical Trials	Tampa	Florida
United States	Moore Clinical Research	Tampa	Florida
United States	PEAK Research, LLC	Upper Saint Clair	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Encube Ethicals Pvt. Ltd.	Novum Pharmaceutical Research Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Superiority of the test and reference products against the placebo		Day 90 (30 days after completion of a 60 day treatment)