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

NCT02611804 | Completed Phase 3

• 1 other identifier: SYM 2015-01
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 30

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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients with Treatment Success at Visit 4

  Day 90

Study Arms (3)

Diclofenac Sodium Gel, 3%

EXPERIMENTAL

Diclofenac Sodium Gel, 3%, applied twice daily for 60 days

Drug: Diclofenac sodium

Solaraze®

ACTIVE COMPARATOR

Solaraze® (diclofenac sodium) Gel, 3%, applied twice daily for 60 days

Drug: Diclofenac sodium

Vehicle of Test Product

PLACEBO COMPARATOR

Vehicle of Test Product, Gel, applied twice daily for 60 days

Drug: Placebo

Interventions

Diclofenac sodium DRUG

Diclofenac Sodium Gel, 3%

Placebo DRUG

Vehicle of Test Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (30)

Agave Clinical Research

Mesa, Arizona, 85202, United States

Location

Radiant Research, Inc.

Tucson, Arizona, 85712, United States

Location

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

TCR Medical Corporation

San Diego, California, 92123, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Horizons Clinical Research Center

Denver, Colorado, 80220, United States

Location

Olympian Clinical Research

Clearwater, Florida, 33757, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

DS Research

Louisville, Kentucky, 40202, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

DermOne of North Carolina

Wilmington, North Carolina, 28401, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Radiant Research

Cincinnati, Ohio, 45249, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Radiant Research

Anderson, South Carolina, 29621, United States

Location

Greenville Dermatology

Greenville, South Carolina, 29607, United States

Location

Dermatology Associates of Knoxville

Knoxville, Tennessee, 37917, United States

Location

The Skin Wellness Center

Knoxville, Tennessee, 37922, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

ACRC Trials

Plano, Texas, 75024, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Stephen Miller, M.D.

San Antonio, Texas, 78249, United States

Location

Dermatology Research Center

Salt Lake City, Utah, 84117, United States

Location

The Education and Research Foundation

Lynchburg, Virginia, 24501, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

US (30)