CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 813 enrolled
Drug / intervention
IDP-123 Lotion +1 moredrug
Likely dose
Tazarotene 0.045% applied as lotionAI-extracted
Key inclusion· 5
  • ✓Age at least 9 years old
  • ✓Moderate or severe acne on Evaluator's Global Severity assessment (score 3 or 4)
  • ✓Facial inflammatory lesion count 20-50 (papules, pustules, nodules)
  • ✓Facial non-inflammatory lesion count 25-100 (comedones)
Key exclusion· 6
  • ✕Use of investigational drug or device within 30 days or concurrent participation in another research study
  • ✕Dermatological conditions on face that interfere with evaluations (acne conglobata, acne fulminans, secondary acne, perioral dermatitis, rosacea, gram-negative folliculitis, dermatitis, eczema)
  • ✕Underlying disease or dermatological condition requiring interfering topical or systemic therapy or making lesion count inconclusive
  • ✕Facial beard or mustache that could interfere with study assessments

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

Search/NCT03168321
NCT03168321Phase 3Completed
CompareCT.gov

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris

Bausch Health Americas, Inc.·interventional·Posted May 30, 2017·Updated Apr 1, 2021

In Brief

A Phase 3 clinical trial evaluating IDP-123 Lotion and IDP-123 Vehicle Lotion for Acne Vulgaris. Completed, enrolled 813 participants across 45 sites in 2 countries.

Detailed Summary

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartJun 29, 2017
Primary CompletionJun 7, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.1 years ago

Interventions

IDP-123 Lotiondrug

Tazarotene 0.045% Lotion

IDP-123 Vehicle Lotiondrug

Vehicle Lotion