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
NCT ID: NCT02611804
Last Updated: 2017-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
492 participants
INTERVENTIONAL
2015-10-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Diclofenac Sodium Gel, 3%
Diclofenac Sodium Gel, 3%, applied twice daily for 60 days
Diclofenac sodium
Solaraze®
Solaraze® (diclofenac sodium) Gel, 3%, applied twice daily for 60 days
Diclofenac sodium
Vehicle of Test Product
Vehicle of Test Product, Gel, applied twice daily for 60 days
Placebo
Interventions
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Diclofenac sodium
Diclofenac sodium
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Teva Pharmaceuticals USA
INDUSTRY
Responsible Party
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Locations
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Agave Clinical Research
Mesa, Arizona, United States
Radiant Research, Inc.
Tucson, Arizona, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 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
Horizons Clinical Research Center
Denver, Colorado, United States
Olympian Clinical Research
Clearwater, Florida, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
DS Research
Louisville, Kentucky, United States
Dermatology Consulting Services
High Point, North Carolina, United States
DermOne of North Carolina
Wilmington, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Radiant Research
Cincinnati, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Omega Medical Research
Warwick, Rhode Island, United States
Radiant Research
Anderson, South Carolina, United States
Greenville Dermatology
Greenville, South Carolina, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
The Center for Skin Research
Houston, Texas, United States
ACRC Trials
Plano, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Stephen Miller, M.D.
San Antonio, Texas, United States
Dermatology Research Center
Salt Lake City, Utah, United States
The Education and Research Foundation
Lynchburg, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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Other Identifiers
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SYM 2015-01
Identifier Type: -
Identifier Source: org_study_id
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