NCT02537483

A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (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-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.

Detailed description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel in comparison with IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. IDP-120 is a gel for the topical treatment of acne.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	IDP-120 Gel	Investigational Product: IDP-120 Gel
DRUG	IDP-120 Component A	Comparator Product: IDP-120 Component A
DRUG	IDP-120 Component B	Comparator Product: IDP-120 Component B
DRUG	IDP-120 Vehicle Gel	Comparator Product: IDP-120 Vehicle Lotion

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-09-01
• Last updated: 2015-09-14