Trial reportArchives of dermatological research2025
Assessing the efficacy and safety profiles of 0.025% tretinoin in treating axillary hyperpigmentation with acanthosis nigricans: a randomized double-blinded study.
Trial report in Archives of dermatological research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
4 authors.
Funding
Abstract
Acanthosis nigricans (AN) is a dermatological condition, marked by hyperpigmentation and skin thickening, frequently affecting body folds like the axillae. Treatment options for axillary hyperpigmentation remain underexplored. This study evaluated the efficacy of 0.025% tretinoin cream in treating axillary hyperpigmentation associated with AN. In a randomized, intra-individual, split-side design study, participants applied 0.025% tretinoin cream on one axilla and a cream-based on the other. The study spanned 12 weeks, with topical application for the first 8 weeks, followed by a 4-week cessation period. Efficacy was measured using the melanin (M) index via narrowband reflectance spectrophotometry. Overall success was evaluated through investigator- and participant-global evaluation (IGE and PGE) scales, with adverse effects monitored. Twenty participants completed the study. The 0.025% tretinoin cream significantly reduced hyperpigmentation compared to the control (p < 0.001). By week 8, the mean M index reduction with tretinoin was 28.05%±12.20%, versus 6.55%±12.66% with the control. Hyperpigmentation reappeared partially after treatment cessation. By week 8, 75% of participants in the tretinoin group achieved more than 75% improvement in IGE, compared to 35% in the cream-based group. Similarly, 75% of the tretinoin group reported more than 75% improvement in PGE, whereas only 15% of the cream-based group achieved more than 50% improvement. Adverse effects were mild and included slight erythema, peeling, and itching. The 0.025% tretinoin cream significantly improved AN patients' axillary hyperpigmentation, demonstrating a safe and effective treatment option with minimal side effects.
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