NCT00975143

Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne

A Double-Blind, Randomized, Phase III, Parallel Group Study Evaluating the Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 925 (actual)
• Sponsor: Cipher Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 12 Years – 54 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice daily with meals.

Conditions

• Severe Nodular Acne

Interventions

Type	Name	Description
DRUG	CIP-Isotretinoin	0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
DRUG	Isotretinoin	0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-09-11
• Last updated: 2014-07-04
• Results posted: 2014-07-04

Locations

49 sites across 2 countries: United States, Canada