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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

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dc.contributor.authorChan, R-
dc.contributor.authorPark, K C-
dc.contributor.authorLee, M H-
dc.contributor.authorLee, E-S-
dc.contributor.authorChang, S E-
dc.contributor.authorLeow, Y H-
dc.contributor.authorTay, Y-K-
dc.contributor.authorLegarda-Montinola, F-
dc.contributor.authorTsai, R-Y-
dc.contributor.authorTsai, T-H-
dc.contributor.authorShek, S-
dc.contributor.authorKerrouche, N-
dc.contributor.authorThomas, G-
dc.contributor.authorVerallo-Rowell, V-
dc.date.accessioned2010-06-07T04:30:34Z-
dc.date.available2010-06-07T04:30:34Z-
dc.date.issued2008-07-12-
dc.identifier.citationBritish Journal of Dermatology 2008; 159(3):697-703en
dc.identifier.issn1365-2133 (Electronic)-
dc.identifier.urihttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18616780-
dc.identifier.urihttps://hdl.handle.net/10371/67523-
dc.description.abstractBACKGROUND: 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%.en
dc.language.isoenen
dc.publisherWiley-Blackwellen
dc.subjectAdministration, Cutaneousen
dc.subjectAnalysis of Varianceen
dc.subjectAsian Continental Ancestry Groupen
dc.subjectDouble-Blind Methoden
dc.subjectDrug Combinationsen
dc.subjectFacial Dermatoses/*drug therapyen
dc.subjectFemaleen
dc.subjectFluocinolone Acetonide/*administration & dosageen
dc.subjectHumansen
dc.subjectHydroquinones/*administration & dosageen
dc.subjectMaleen
dc.subjectMelanosis/*drug therapy/ethnology/psychologyen
dc.subjectOintmentsen
dc.subjectPatient Satisfactionen
dc.subjectTreatment Outcomeen
dc.subjectTretinoin/*administration & dosageen
dc.titleA 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 melasmaen
dc.typeArticleen
dc.identifier.doi10.1111/j.1365-2133.2008.08717.x-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Dermatology (피부과학전공)Journal Papers (저널논문_피부과학전공)
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