Clinical trial NCT02611804: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Patients with Treatment Success at Visit 4
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Agave Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Wilmington
country: United States
facility: DermOne of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Greenville
country: United States
facility: Greenville Dermatology
state: South Carolina
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: Plano
country: United States
facility: ACRC Trials
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller, M.D.
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Lynchburg
country: United States
facility: The Education and Research Foundation
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
References: