Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma

NCT05119413 ↗

Phase 2 Completed 40 enrolled Centre Hospitalier Universitaire de Nice

RandomizedParallel-groupDouble-blindTreatment

Summary

Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.

Timeline

Start: 2021-11-30
Primary completion: 2022-09-16
Completion: 2022-12-15

Outcome

Missed primary endpoint

paper The mean difference between the two groups was -1.49 (IC 95% -3.52 to 0.54, p = 0.14). PMID 37620285 ↗

Publications

Results Bertold C, Fontas E, Singh T, Gastaut N, Ruitort S, Wehrlen Pugliese S, Passeron T. Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydroquinone	Small molecule	—	Topical
Subject	isobutylamido-thiazolyl-resorcinol	Unknown	—	Topical
Background	Retinoic acid	Small molecule	—	Topical