CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 820 enrolled
Drug / intervention
IDP 121 Lotion +1 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/NCT02965456
NCT02965456Phase 3Completed
CompareCT.gov

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Bausch Health Americas, Inc.·interventional·Posted Nov 16, 2016·Updated Dec 18, 2019

In Brief

A Phase 3 clinical trial evaluating IDP 121 Lotion and IDP-121 Vehicle Lotion for Acne. Completed, enrolled 820 participants across 34 sites.

Detailed Summary

The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score \[EGSS\] of 3 \[moderate\] or 4 \[severe\]).

Study Details

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

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 16, 2016
Enrollment StartNov 4, 2015
Primary CompletionFeb 23, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.6 years ago

Interventions

IDP 121 Lotiondrug

IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.

IDP-121 Vehicle Lotiondrug

IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.