A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp

Actinic Keratosis Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611804
• Other study ID #: SYM 2015-01
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2015
• Last updated: May 3, 2017
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: Teva Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy and safety profiles of Teva's Diclofenac Sodium Gel, 5% (test product) to Solaraze® (diclofenac sodium) Gel, 3% (reference product) to demonstrate the clinical equivalence and to show that the efficacy of the 2 active formulations is superior to that of vehicle in treating subjects with actinic keratosis (AK) on the face or bald scalp.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing and able to provide written informed consent for the study.

• At least 18 years of age

• Immunocompetent male or nonpregnant and nonlactating female. Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1, must be willing to use an acceptable form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double-barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device IUD (Mirena®), Essure®, and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active.

• Clinical diagnosis of AK, defined as = 5 and = 10 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions, each at least 4 mm in diameter, contained within a 25-cm2 treatment area on either the face or bald scalp, but not both face and scalp.

• In general good health and free from any clinically significant disease, other than AK, that might interfere with the study evaluations.

• Willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, attend the required visits, comply with therapy prohibitions, and be able to complete the study.

Exclusion Criteria:

• Presence of active gastrointestinal ulceration or bleeding.

• Presence of severe renal or hepatic impairment.

• Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, sunburn, or other possible confounding skin conditions on the treatment area of either the face or bald scalp.

• Clinically significant systemic disease (immunological deficiencies), unstable medical disorder, life-threatening disease, or current malignancies.

• Use within 6 months (180 days) prior to randomization of oral isotretinoin.

• Use within 6 months (180 days) prior to randomization on the face or bald scalp where the designated treatment area is located of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy.

• Use within 6 months (180 days) prior to randomization of systemic cancer chemotherapy medications.

• Use within 1 month (30 days) prior to randomization on the face of bald scalp where the designated treatment are is located 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, 10) other treatments for actinic keratosis.

• Use within 1 month (30 days) prior to randomization of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) systemic (oral and injectable) corticosteroids, 4) cytotoxic drugs. Intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study. Intra-articular injection of steroids is acceptable for this study.

• Known hypersensitivity or allergies to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or any component of the study medication (in any dosage form).

• Previous or current history of allergies to aspirin (ASA) or other NSAIDS.

• Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do not agree to use an acceptable form of birth control during the study.

• Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluation or optimal participation in the study.

• Use of any investigational drug or investigational device within 1 month (30 days) prior to the randomization.

• Previous participation in this study.

• Current involvement in activities that require excessive or prolonged sun exposure.

• Consumption of excessive alcohol, abuse of drugs, or a condition that could compromise the subject's ability to comply with study requirements.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Diclofenac sodium

• Diclofenac sodium

• Placebo

Locations

Country	Name	City	State
United States	Radiant Research	Anderson	South Carolina
United States	DermResearch, Inc.	Austin	Texas
United States	Radiant Research	Cincinnati	Ohio
United States	Olympian Clinical Research	Clearwater	Florida
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Horizons Clinical Research Center	Denver	Colorado
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Greenville Dermatology	Greenville	South Carolina
United States	Dermatology Consulting Services	High Point	North Carolina
United States	The Center for Skin Research	Houston	Texas
United States	Dermatology Associates of Knoxville	Knoxville	Tennessee
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	DS Research	Louisville	Kentucky
United States	The Education and Research Foundation	Lynchburg	Virginia
United States	Agave Clinical Research	Mesa	Arizona
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Renstar Medical Research	Ocala	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	ACRC Trials	Plano	Texas
United States	Dermatology Research Center	Salt Lake City	Utah
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Stephen Miller, M.D.	San Antonio	Texas
United States	Medical Center for Clinical Research	San Diego	California
United States	TCR Medical Corporation	San Diego	California
United States	Clinical Science Institute	Santa Monica	California
United States	Premier Clinical Research	Spokane	Washington
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	DermOne of North Carolina	Wilmington	North Carolina
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients with Treatment Success at Visit 4		Day 90