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A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma

Cited 62 time in Web of Science Cited 81 time in Scopus
Authors
Chan, R; Park, K C; Lee, M H; Lee, E-S; Chang, S E; Leow, Y H; Tay, Y-K; Legarda-Montinola, F; Tsai, R-Y; Tsai, T-H; Shek, S; Kerrouche, N; Thomas, G; Verallo-Rowell, V
Issue Date
2008-07-12
Publisher
Wiley-Blackwell
Citation
British Journal of Dermatology 2008; 159(3):697-703
Keywords
Administration, CutaneousAnalysis of VarianceAsian Continental Ancestry GroupDouble-Blind MethodDrug CombinationsFacial Dermatoses/*drug therapyFemaleFluocinolone Acetonide/*administration & dosageHumansHydroquinones/*administration & dosageMaleMelanosis/*drug therapy/ethnology/psychologyOintmentsPatient SatisfactionTreatment OutcomeTretinoin/*administration & dosage
Abstract
BACKGROUND: Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge. OBJECTIVES: To compare the efficacy and safety of a triple combination [TC: fluocinolone acetonide 0.01%, hydroquinone (HQ) 4%, tretinoin 0.05%] vs. HQ 4% after 8 weeks of treatment of moderate to severe facial melasma in Asian patients. METHODS: This was a multicentre, randomized, controlled, investigator-blinded, parallel comparison study. East and South-East Asian patients aged 18 years or older, with a clinical diagnosis of moderate to severe melasma, were enrolled in this study. Patients were enrolled at baseline and treated daily for 8 weeks with TC cream (one application at bedtime) or HQ cream (twice daily). There were four study visits: at baseline and weeks 2, 4 and 8. The primary efficacy variable was the melasma global severity score (GSS). Other outcome measures included Melasma Area and Severity Index, global improvement and patient satisfaction. Safety was assessed through the reporting of adverse events. RESULTS: TC had superior efficacy to HQ for the primary variable: 77/120 patients (64.2%) on TC had GSS 'none' or 'mild' at week 8 vs. 48/122 patients (39.4%) on HQ (P < 0.001). The secondary efficacy variables confirmed these results. Patient satisfaction was in favour of TC (90/127, 70.8%, vs. 64/129, 49.6%; P = 0.005). More patients had related adverse events on TC (63/129, 48.8%) than on HQ (18/131, 13.7%) but most were mild and none was severe. CONCLUSIONS: Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.
ISSN
1365-2133 (Electronic)
Language
English
URI
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18616780

https://hdl.handle.net/10371/67523
DOI
https://doi.org/10.1111/j.1365-2133.2008.08717.x
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College of Medicine/School of Medicine (의과대학/대학원)Dermatology (피부과학전공)Journal Papers (저널논문_피부과학전공)
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