Cenon

Researchers are studying moderate acne in patients with darker skin types (Fitzpatrick phototypes IV-VI) to compare the effects of oral isotretinoin against the current standard treatment on acne-related pigmentation (ARP). ARP affects about 65% of these patients and impacts quality of life by causing discoloration. The study aims to see if isotretinoin, usually prescribed only after antibiotics fail, is better as a first-line treatment for ARP severity after six months. This is a Phase 3, multicenter, randomized controlled trial involving 420 subjects. Participants will receive either oral isotretinoin starting at 0.5 mg/kg daily (adjusted based on tolerance and response, with a total cumulative dose target of 120 to 150 mg/kg) or a topical cream (retinoic acid or adapalene) combined with oral antibiotics (doxycycline or lymecycline) for the first three months. After three months, the effectiveness will be checked; if acne improves, antibiotics stop but topical treatment continues. If acne remains moderate or severe, isotretinoin may be started. The study compares these approaches over six months. During the study, participants will be monitored for acne severity and pigmentation changes. They must have a cell phone capable of taking high-quality selfie pictures for monitoring. Safety tests include blood work for liver function and lipids. Women of childbearing potential will have pregnancy tests and require effective contraception. Researchers will assess the severity of acne-related pigmentation at six months as the primary outcome. The study will last six months with close follow-up and clinical evaluations to track treatment response and safety.