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

R. Chan, K. C. Park, M. H. Lee, E. S. Lee, S. E. Chang, Y. H. Leow, Y. K. Tay, F. Legarda-Montinola, R. Y. Tsai, T. H. Tsai, S. Shek, N. Kerrouche, G. Thomas, V. Verallo-Rowell, Pascale Soto

Research output: Contribution to journalArticle

73 Citations (Scopus)

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%.

Original languageEnglish
Pages (from-to)697-703
Number of pages7
JournalBritish Journal of Dermatology
Volume159
Issue number3
DOIs
Publication statusPublished - Sep 2008

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Fluocinolone Acetonide
Melanosis
Tretinoin
Randomized Controlled Trials
Safety
Patient Satisfaction
Hyperpigmentation
hydroquinone
Research Personnel
Outcome Assessment (Health Care)

Keywords

  • Asiatic skin
  • Hydroquinone
  • Melasma
  • Randomized controlled trial
  • Triple combination

ASJC Scopus subject areas

  • Dermatology

Cite this

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. / 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.; Soto, Pascale.

In: British Journal of Dermatology, Vol. 159, No. 3, 09.2008, p. 697-703.

Research output: Contribution to journalArticle

Chan, R, Park, KC, Lee, MH, Lee, ES, Chang, SE, Leow, YH, Tay, YK, Legarda-Montinola, F, Tsai, RY, Tsai, TH, Shek, S, Kerrouche, N, Thomas, G, Verallo-Rowell, V & Soto, P 2008, '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', British Journal of Dermatology, vol. 159, no. 3, pp. 697-703. https://doi.org/10.1111/j.1365-2133.2008.08717.x
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. ; Soto, Pascale. / 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. In: British Journal of Dermatology. 2008 ; Vol. 159, No. 3. pp. 697-703.
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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{\%}.",
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T1 - 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

AU - Chan, R.

AU - Park, K. C.

AU - Lee, M. H.

AU - Lee, E. S.

AU - Chang, S. E.

AU - Leow, Y. H.

AU - Tay, Y. K.

AU - Legarda-Montinola, F.

AU - Tsai, R. Y.

AU - Tsai, T. H.

AU - Shek, S.

AU - Kerrouche, N.

AU - Thomas, G.

AU - Verallo-Rowell, V.

AU - Soto, Pascale

PY - 2008/9

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N2 - 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%.

AB - 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%.

KW - Asiatic skin

KW - Hydroquinone

KW - Melasma

KW - Randomized controlled trial

KW - Triple combination

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