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

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.

Timeline

Start

2009-09

Primary completion

2011-05

Completion

2011-05

Outcome

Met primary endpoint

registry LS Mean Difference 0.1382 (95% CI -0.2712 to 0.5475) NCT00975143 ↗

registry Proportion difference -2.10 (95% CI -7.94 to 3.74) NCT00975143 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isotretinoin	Other / unclassified	1 mg/kg	Oral

Indications