Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Diclofenac

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

GDC 695 gel applied topically as directed.

Diclofenac sodium gel, 3% applied topically as directed.

Vehicle gel applied topically as directed.

GDC 695

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

Diclofenac Sodium Gel, 3%

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

Vehicle gel

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 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

AEs will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported.

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).

Balmoral Medical company

There were a total of four (4) Serious Adverse Events (SAEs) in three (3) subjects in the Reference group (Diclofenac sodium gel); one of these subjects experienced two (2) SAEs: (1) Bladder transitional cell carcinoma and (2) Haematuria. There were a total of six (6) SAEs in the five (5) subjects in the Placebo group (Vehicle gel); one of these subjects experienced two (2) SAEs: (1) Flank pain and (2) Lung infiltration.

GDC 695 gel applied topically as directed.

GDC 695: GDC 695 is a topical gel.

Diclofenac sodium gel, 3% applied topically as directed.

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

Diclofenac Sodium Gel

Vehicle gel applied topically as directed.

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

Placebo

GDC 695 Gel

Total

Age, Continuous

Sex: Female, Male

Ethnicity

Race/Ethnicity, Customized

Race

United States

Region of Enrollment

Baseline demographic information is based on the safety population, which includes all randomized subjects who received at least one dose of the test article. Four subjects (2 in Test Drug group, 1 in Reference Drug group, and 1 in Placebo group) were excluded for not applying any test article.

Gage Development Company

Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of GDC 695 gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.

Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of Diclofenac sodium gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.

Analysis shown is based on the modified Intent-to-Treat (mITT) population, defined as all randomized subjects who met the following requirements, 1) met all inclusion/exclusion criteria; 2) applied at least one dose of test article; 3) and returned for at least one post-baseline evaluation clinic visit (Visits 3, 5, or 6).

Number of Subjects With Complete Clearance of AK Lesions

Adverse Events (AEs)

The test drug is GDC 695 gel applied topically as directed.

GDC 695: GDC 695 is a topical gel.

The reference drug is Diclofenac sodium gel, 3% applied topically as directed.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses	NCT02952898	Actinic Keratos...	GDC 695 Diclofenac Sodi... Vehicle gel	18 Years -	Balmoral Medical company
Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses	NCT02952898	Actinic Keratos...	GDC 695 Diclofenac Sodi... Vehicle gel	18 Years -	Balmoral Medical company

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