Clinical trial NCT02952898: Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: solar keratoses
Lead sponsor: Balmoral Medical company
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 665
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Subjects With Complete Clearance of AK Lesions
timeFrame: Day 90 (30 days after completion of 60 days of treatment)
Secondary outcomes:
Other outcomes:
measure: Adverse Events (AEs)
timeFrame: Day 0 through Day 90
Locations:
city: Fort Smith
country: United States
facility: Site 07
state: Arkansas
city: San Diego
country: United States
facility: Site 14
state: California
city: San Ramon
country: United States
facility: Site 24
state: California
city: Clearwater
country: United States
facility: Site 22
state: Florida
city: North Miami Beach
country: United States
facility: Site 01
state: Florida
city: Ocala
country: United States
facility: Site 27
state: Florida
city: Tampa
country: United States
facility: Site 12
state: Florida
city: Carmel
country: United States
facility: Site 05
state: Indiana
city: Plainfield
country: United States
facility: Site 02
state: Indiana
city: Saint Joseph
country: United States
facility: Site 25
state: Missouri
city: Albuquerque
country: United States
facility: Site 21
state: New Mexico
city: Warwick
country: United States
facility: Site 03
state: Rhode Island
city: Anderson
country: United States
facility: Site 26
state: South Carolina
city: Greenville
country: United States
facility: Site 04
state: South Carolina
city: Norfolk
country: United States
facility: Site 28
state: Virginia
city: Spokane
country: United States
facility: Site 10
state: Washington
Study officials:
References: