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

NCT02952898 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 665

Last updated 2020-01-07

Study results available
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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

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.

Sponsors & Collaborators

  • Balmoral Medical company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-27
Primary Completion
2017-07-11
Completion
2017-09-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02952898 on ClinicalTrials.gov