Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Phase 3 Completed 820 enrolled Bausch Health Americas, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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 \[severe\]).

Timeline

Start: 2015-11-04
Primary completion: 2017-02-23
Completion: 2017-02-23

Outcome

Met primary endpoint

registry analysis (superiority test); IDP-121 Lotion vs IDP-121 Vehicle Lotion; p <0.001; ANCOVA; note: Threshold for significance at 0.05. NCT02965456 ↗

registry analysis (superiority test); IDP-121 Lotion vs IDP-121 Vehicle Lotion; p = 0.007; Regression, Logistic; note: Threshold for significance at 0.05. NCT02965456 ↗

Publications

Tyring SK, Kircik L, Pariser DM, Woolery-Lloyd HC, Harper JC, Bhatt V, Pillai R, Guenin E. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol. 2020 Dec;21(6):891-899. doi: 10.1007/s40257-020-00559-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tretinoin	Unknown	0.05 %	Topical