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

Actinic Keratosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952898
• Other study ID #: GDC-695-001
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2016
• Est. completion date: September 6, 2017

Study information

• Verified date: January 2020
• Source: Gage Development Company, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: September 6, 2017
• Est. primary completion date: July 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• GDC 695
GDC 695 is a topical gel.
• Diclofenac Sodium Gel, 3%
Diclofenac sodium gel, 3% is an FDA-approved drug.
• Vehicle gel
Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gage Development Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events (AEs)	AEs will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported.	Day 0 through Day 90
Primary	Number of Subjects With Complete Clearance of AK Lesions	Complete Clearance was defined as 100% clearance of all Actinic Keratosis (AK) lesions (having a count of zero AKs) in the treatment area (face or bald scalp) at the Day 90 visit (30 Days Post Treatment).	Day 90 (30 days after completion of 60 days of treatment)