Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/12/2019 |
Start Date: | October 27, 2016 |
End Date: | September 6, 2017 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
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.
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.
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
We found this trial at
16
sites
North Miami Beach, Florida 33162
Phone: 305-652-8600
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Greenville, South Carolina 29605
Phone: 864-351-9632
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