CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,236 enrolled
Drug / intervention
GDC 268 Lotion +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03717506
NCT03717506Phase 3Completed

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

Balmoral Medical company·interventional·Posted Oct 24, 2018·Updated May 4, 2021

In Brief

A Phase 3 clinical trial evaluating GDC 268 Lotion, Clindamycin Phosphate Lotion 1%, and 1 other intervention for Acne Vulgaris. Completed, enrolled 1,236 participants across 34 sites.

Detailed Summary

The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 24, 2018
Enrollment StartOct 10, 2018
Primary CompletionFeb 17, 2020
Study CompletionApr 16, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.7 years ago

Interventions

GDC 268 Lotiondrug

GDC 268 is a topical lotion

Clindamycin Phosphate Lotion 1%drug

Clindamycin Phosphate Lotion is an FDA-approved drug product

GDC Vehicle Lotiondrug

GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs