ABSORICA in Patients With Severe Recalcitrant Nodular Acne
Status:
Completed
Trial end date:
2018-04-01
Target enrollment:
Participant gender:
Summary
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males,
non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by
1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or
abstinence are included.
Phase:
Phase 4
Details
Lead Sponsor:
Ranbaxy Inc. Sun Pharmaceutical Industries Limited