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

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: GDC 695; Drug: Diclofenac Sodium Gel, 3%; Drug: Vehicle gel

• Study Type: Interventional
• Enrollment (Actual): 665
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Site 07
  • California
    • San Diego, California, United States, 92117
      • Site 14
    • San Ramon, California, United States, 94582
      • Site 24
  • Florida
    • Clearwater, Florida, United States, 33756
      • Site 22
    • North Miami Beach, Florida, United States, 33162
      • Site 01
    • Ocala, Florida, United States, 34471
      • Site 27
    • Tampa, Florida, United States, 33609
      • Site 12
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Site 05
    • Plainfield, Indiana, United States, 46168
      • Site 02
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Site 25
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Site 21
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Site 03
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Site 26
    • Greenville, South Carolina, United States, 29607
      • Site 04
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Site 28
  • Washington
    • Spokane, Washington, United States, 99202
      • Site 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test Drug; GDC 695 gel applied topically as directed.	Drug: GDC 695; GDC 695 is a topical gel.
ACTIVE_COMPARATOR: Reference Drug; Diclofenac sodium gel, 3% applied topically as directed.	Drug: Diclofenac Sodium Gel, 3%; Diclofenac sodium gel, 3% is an FDA-approved drug.
PLACEBO_COMPARATOR: Placebo; Vehicle gel applied topically as directed.	Drug: Vehicle gel; Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gage Development Company, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2016
• Primary Completion (ACTUAL): July 11, 2017
• Study Completion (ACTUAL): September 6, 2017

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (ESTIMATE): November 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: solar keratoses
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: GDC-695-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO