NCT02535871

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Valeant Pharmaceuticals · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.

Detailed description

This is a multicenter, randomized, double-blind, parallel group, vehicle-controlled, 12-week study to evaluate relative changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Scale (EGSS) in subjects with moderate to severe acne. IDP-121 is a lotion for the topical treatment of acne.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	IDP-121 Lotion	Investigational Product: IDP-121 Lotion
DRUG	IDP-121 Vehicle Lotion	Comparator Product: IDP-121 Vehicle Lotion

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-08-31
• Last updated: 2015-09-14