Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: GDC 695; Diclofenac Sodium Gel, 3%; Vehicle gel
Intervention description: GDC 695 is a topical gel.; Diclofenac sodium gel, 3% is an FDA-approved drug.; Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs.
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 665.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: solar keratoses

Summary:

      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.
    

Eligibility criteria:

        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.