Conditions: Severe Nodular Acne
Keywords: isotretinoin dermatology skin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 925
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: CIP-Isotretinoin intervention 2: Isotretinoin
Intervention descriptions: intervention 1: 0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily. intervention 2: 0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.

Protocol document: