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

NCT02952898 | Completed Phase 3 Results

• 1 other identifier: GDC-695-001
• Study Type: interventional
• Target: 665
• Locations: 1 country
• Sites: 16

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.

Conditions

Actinic Keratosis

Keywords

solar keratoses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events (AEs)

  Day 0 through Day 90

Study Arms (3)

Test Drug

EXPERIMENTAL

GDC 695 gel applied topically as directed.

Drug: GDC 695

Reference Drug

ACTIVE COMPARATOR

Diclofenac sodium gel, 3% applied topically as directed.

Drug: Diclofenac Sodium Gel, 3%

Placebo

PLACEBO COMPARATOR

Vehicle gel applied topically as directed.

Drug: Vehicle gel

Interventions

GDC 695 DRUG

GDC 695 is a topical gel.

Test Drug

Diclofenac Sodium Gel, 3% DRUG

Diclofenac sodium gel, 3% is an FDA-approved drug.

Reference Drug

Vehicle gel DRUG

Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balmoral Medical company: lead

Study Sites (16)

Site 07

Fort Smith, Arkansas, 72916, United States

Location

Site 14

San Diego, California, 92117, United States

Location

Site 24

San Ramon, California, 94582, United States

Location

Site 22

Clearwater, Florida, 33756, United States

Location

Site 01

North Miami Beach, Florida, 33162, United States

Location

Site 27

Ocala, Florida, 34471, United States

Location

Site 12

Tampa, Florida, 33609, United States

Location

Site 05

Carmel, Indiana, 46032, United States

Location

Site 02

Plainfield, Indiana, 46168, United States

Location

Site 25

Saint Joseph, Missouri, 64506, United States

Location

Site 21

Albuquerque, New Mexico, 87106, United States

Location

Site 03

Warwick, Rhode Island, 02886, United States

Location

Site 26

Anderson, South Carolina, 29621, United States

Location

Site 04

Greenville, South Carolina, 29607, United States

Location

Site 28

Norfolk, Virginia, 23507, United States

Location

Site 10

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Gage Development Company
• Organization: Gage Development Company

clinicalinfo@capstonedevservices.com

1-847-999-0600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: October 27, 2016
• Primary Completion: July 11, 2017
• Study Completion: September 6, 2017
• Last Updated: January 7, 2020
• Results First Posted: January 10, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)