Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses

Completed · Phase 3 · Has a placebo group

Conditions studied: Actinic Keratosis

In brief

This research study is being done to compare the safety and effectiveness of GDC 695 (test drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to establish that these two drugs work better than placebo in the treatment of actinic keratosis.

Key facts

Study ID

NCT02952898

Run by

Balmoral Medical company

People needed

665

Starts

2016-10-27

Expected to finish

2017-09-06

Last updated by the study team

2020-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has provided written informed consent.
• Immunocompetent male and/or non-pregnant female, 18 years of age or older.
• Willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
• Clinical diagnosis of actinic keratosis.
• In good general health and free of any disease state or physical condition.
• Women, must be post-menopausal, surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).

You may not qualify if…

• Women who are pregnant, breastfeeding, or are planning to become pregnant or breastfeed during the study.
• Is currently enrolled in another investigational drug or device study or has used an investigational drug or investigational device within 30 days prior to the Baseline Visit (Day 1).
• Has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.
• Is immunosuppressed (e.g., human immunodeficiency virus [ HIV], systemic malignancy, graft host disease, etc.) or is taking medications that suppress the immune system.
• Has experienced an unsuccessful outcome from previous topical diclofenac sodium therapy.
• Has a history of sensitivity to any of the ingredients in the test articles or other excipients in the test or reference drug.
• Has signs or symptoms consistent with the aspirin (ASA) triad.
• Has used topical medications: corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >2%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate, aminolevulinic acid (ALA) or prescription retinoids (e.g., tazarotene, adapalene, tretinoin), over-the-counter (OTC) products labeled as scrubs of any kind which are used to smooth the skin (as they contain some form of exfoliant such as nut shells, coffee grounds, polymer particles, etc.) within the selected treatment area (face or bald scalp) within one month prior to the Baseline Visit.
• Has had cryodestruction or chemodestruction, curettage, photodynamic therapy (PDT), surgical excision, or other treatments for AK within the selected treatment area (face or bald scalp) within one month prior to the Baseline Visit.
• Has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within one month prior to the Baseline Visit.
• Has used oral isotretinoin within six months prior to the Baseline Visit.
• Has used chemical peels, including but not limited to alphahydroxy acid, betahydroxy acid, bichloroacetic acid, trichloroacetic acid, and phenol within the selected treatment area (face or bald scalp) within six months prior to the Baseline Visit.
• Has had dermatologic procedures or surgeries such as: laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, ultraviolet B (UVB) therapy, ALA-PDT, or dermabrasion within the selected treatment area (face or bald scalp) within six months prior to the Baseline Visit.
• Has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or bald scalp).
• Has active gastrointestinal ulceration or bleeding or has a history of gastrointestinal bleeds due to use of aspirin or other NSAIDs.
• Has severe renal or hepatic impairment.
• Has any condition which, in the investigator's opinion, could interfere with the evaluation of the test drugs or that could make it unsafe or preclude the subject's ability to fully participate in this research study.

Where it is running

• Site 07 — Fort Smith, Arkansas, United States
• Site 14 — San Diego, California, United States
• Site 24 — San Ramon, California, United States
• Site 22 — Clearwater, Florida, United States
• Site 01 — North Miami Beach, Florida, United States
• Site 27 — Ocala, Florida, United States
• Site 12 — Tampa, Florida, United States
• Site 05 — Carmel, Indiana, United States
• Site 02 — Plainfield, Indiana, United States
• Site 25 — Saint Joseph, Missouri, United States
• Site 21 — Albuquerque, New Mexico, United States
• Site 03 — Warwick, Rhode Island, United States
• Site 26 — Anderson, South Carolina, United States
• Site 04 — Greenville, South Carolina, United States
• Site 28 — Norfolk, Virginia, United States
• Site 10 — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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