Abstract
INTRODUCTION: Hydroquinone, used alone or in combination with a retinoid and corticosteroid, is the preferred first-line treatment for melasma. However, it is associated with side effects such as irritation, erythema, dryness, and exogenous ochronosis. As a result, alternative agents like kojic acid, tranexamic acid, and cysteamine are increasingly being prescribed to minimize these adverse effects. AIM: This study compared the effectiveness, safety, and tolerability of 5% cysteamine cream with 2% kojic acid cream in Indian adult females with melasma. METHODS: This prospective, randomized, open-label, comparative clinical study involved 72 adult females with facial melasma, who were randomized 1:1 into two groups and instructed to apply either 5% cysteamine or 2% kojic acid cream once daily at night for 16 weeks. The primary endpoints were improvement in modified Melasma Area Severity Index (mMASI) scores, melanin content, dermatological assessment of cosmetic acceptability, and a subject questionnaire on product characteristics and acceptability. RESULTS: At week 16, the cysteamine group showed a numerically greater mean percentage reduction in mMASI scores (12.25% vs. 10%) and melanin content in lesions by the Mexameter (5.13% vs. 4.81%) (Courage + Khazaka Electronic, Cologne, Germany) from baseline compared to the kojic acid group, though the differences were not statistically significant. No abnormal clinical or functional signs were reported during the study. CONCLUSION: Five percent cysteamine cream demonstrated comparable effectiveness to 2% kojic acid cream in melasma patients, with the cysteamine group showing a numerical superiority in mMASI scores and Mexameter readings. Both treatments were well tolerated with no adverse effects. Therefore, 5% cysteamine cream is a valuable addition to the medical management of melasma.