Efficacy and Safety of Cysteamine-Isobionicamide Complex in Postinflammatory Hyperpigmentation: A Randomized, Double Blinded, Vehicle-Controlled Trial

Abstract

Postinflammatory hyperpigmentation (PIH) is a common acquired hyperpigmentation disorder that can cause significant psychosocial impacts. Cysteamine has been shown to be an effective depigmenting agent for hyperpigmentation disorders, and a clinical trial was conducted to assess the efficacy and safety of cysteamine-isobionicamide complex for treating PIH. Forty patients were randomized into treatment and control groups, with assessments collected at baseline, week 4, 8, and 16. The treatment group showed significant improvement in dermatological assessments, MASI score, TPHI score, and life quality score compared to the control group. Mexameter® and VISIA skin analysis also showed significant improvement in the melanin index and erythema index score at week 16, with cellular resolution OCT imaging revealing decreased melanosome capping and fewer hyper-reflective melanophages. This study suggests that the cysteamine-isobionicamide complex has the potential to be a viable treatment option for PIH.

Transglutaminase 2 in diabetes mellitus: Unraveling its multifaceted role and therapeutic implications for vascular complications

“…Cysteamine exhibits therapeutic potential for DR and vascular leakage-associated diseases 25 . Additionally, the aminothiol is beneficial in conditions such as cystinosis 117 , nonalcoholic fatty liver disease 118 , neurodegenerative diseases like Alzheimer's, Huntington's, and Parkinson's diseases 119 , 120 , and postinflammatory hyperpigmentation 121 . There is a recent report from three clinical trial programs 122 , suggesting long-term clinical benefits of delayed-release cysteamine bitartrate capsules in patients with nephropathic cystinosis.…”