NCT02952898

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 665 (actual)
• Sponsor: Balmoral Medical company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2016-10-27
• Primary completion: 2017-07-11
• Completion: 2017-09-06
• First posted: 2016-11-02
• Last updated: 2020-01-07
• Results posted: 2019-01-10

Locations

16 sites across 1 country: United States