The DOI matches its Crossref record; 27 of the 28 references it cites were found in a registry or an index.
A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 001, hydroquinone 4, tretinoin 005) compared with hydroquinone 4 cream in Asian patients with moderate to severe melasma
Open accessAbstract
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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In the citing paper
“The level of evidence for this study is graded as Level 2b according to the Oxford Centre for Evidence‐Based Medicine.”
From Cosmeceuticals in photoaging: A review. (2024) · cites this paper as [69]
In the citing paper
“The study found that the triple combination treatment was significantly more effective in reducing pigmentation and improving melasma compared to hydroquinone alone.”
From Cosmeceuticals in photoaging: A review. (2024) · cites this paper as [69]
In the citing paper
“However, the study had some limitations including a small sample size and a relatively short follow‐up period of 12 weeks. Additionally, the study did not report any adverse events or long‐term outcomes of the triple combination treatment.”
From Cosmeceuticals in photoaging: A review. (2024) · cites this paper as [69]
Citations
Cites
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Topical retinoic acid (tretinoin) for melasma in black patients. A vehicle-controlled clinical trial
Kimbrough-Green, C. K. (1994) · Archives of Dermatology · doi:10.1001/archderm.130.6.727 · Cited by 418
Melasma: histopathological characteristics in 56 Korean patients
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Self-citationEthnic skin types: are there differences in skin structure and function? 1
Rawlings, A. V. (2006) · International Journal of Cosmetic Science · doi:10.1111/j.1467-2494.2006.00302.x · Cited by 389
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Pandya, A. G., & Guevara, I. L. (2000) · Dermatologic Clinics · doi:10.1016/s0733-8635(05)70150-9 · Cited by 248
Rendon, M. I., Berneburg, M., Arellano, I., & Picardo, M. (2006) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2005.12.039 · Cited by 215
Light Microscopic, Immunohistochemical, and Ultrastructural Alterations in Patients with Melasma
Grimes, P. E., Yamada, N., & Bhawan, J. (2005) · American Journal of Dermatopathology · doi:10.1097/01.dad.0000154419.18653.2e · Cited by 209
Acquired, bilateral nevus of Ota-like macules
Hori, Y., Kawashima, M., Oohara, K., & Kukita, A. (1984) · Journal of the American Academy of Dermatology · doi:10.1016/s0190-9622(84)80313-8 · Cited by 207
Efficacy and safety of a new triple-combination agent for the treatment of facial melasma.
Taylor, S. C., Torok, H., Jones, T., Lowe, N. J., Rich, P. A., Tschen, E. H., Menter, A., Baumann, L., Wieder, J. J., Jarratt, M., et al. (2003) · PubMed · Cited by 170
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- Mosher, 1999, Fitzpatricks Dermatology in General Medicine, 945
- Kumarasinghe, 2005, The Asian Skin A Reference Color Atlas of Dermatology, 48
Cited by
Sorted by citations
Melasma: an Up-to-Date Comprehensive Review
Ogbechie-Godec, O. A., & Elbuluk, N. (2017) · Dermatology and Therapy · doi:10.1007/s13555-017-0194-1 · Cited by 418
“01% was superior to HQ 4% monotherapy in improving melasma [72].”
BackgroundDavis, E. C., & Callender, V. D. (2010) · PubMed Central · Cited by 412
Del Bino, S., Duval, C., & Bernerd, F. (2018) · International Journal of Molecular Sciences · doi:10.3390/ijms19092668 · Cited by 315
Melasma, a photoaging disorder
Passeron, T., & Picardo, M. (2018) · Pigment Cell & Melanoma Research · doi:10.1111/pcmr.12684 · Cited by 274
“The Kligman formula (corticosteroid, retinoic acid and hydroquinone mixture) is the most effective treatment, especially in its stabilized form (Chan et al., 2008).”
BackgroundMelasma Treatment: An Evidence-Based Review
McKesey, J., Tovar‐Garza, A., & Pandya, A. G. (2019) · American Journal of Clinical Dermatology · doi:10.1007/s40257-019-00488-w · Cited by 251
“also reported higher efficacy using TCC when compared with 4% HQ twice daily [46].”
Method
Metadata
- 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.
- Affiliations
- National Skin Centre (SG)
- Seoul National University Bundang Hospital (KR)
- Kyung Hee University (KR)
- Ajou University Hospital (KR)
- Asan Medical Center (KR)
- Changi General Hospital (SG)
- Makati Medical Center (PH)
- Wan Fang Hospital (TW)
- Queen Mary Hospital (CN)
- Galderma (France) (FR)
- Corresponding author
- Chan, R.
- Venue
- British Journal of Dermatology
- Publisher
- Oxford University Press (OUP)
- Published
- 2008-06
- Volume
- 159
- Issue
- 3
- Pages
- ???-???
- ISSN
- 0007-0963 (ISSN-L)
- 1365-2133
- OpenAlex
- W1980482640
- Cited by
- 132
- References
- 28
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 13 · 2023: 4 · 2022: 15 · 2021: 3 · 2020: 7 · 2019: 7 · 2018: 8 · 2017: 14 · 2016: 6 · 2015: 7 · 2014: 12 · 2013: 3 · 2012: 8
- FWCI
- 7.15
- Type
- journal article
- Language
- en
- Open access
- Locations
- British Journal of Dermatology (publishedVersion)
- PubMed (publishedVersion)
- AJOU Open Repository (Ajou University) (submittedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- Galderma
- Topics
- Health Sciences › Medicine › Dermatology › Dermatologic Treatments and Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › melanin and skin pigmentation
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Keywords
- melasma, triple combination therapy, fluocinolone acetonide, hydroquinone, all-trans retinoic acid, Asian patients, facial hyperpigmentation, Melasma Area and Severity Index, patient satisfaction, adverse events, topical treatment efficacy
- MeSH terms
- Administration, Cutaneous, Adult, Analysis of Variance, Double-Blind Method, Drug Combinations, Facial Dermatoses, Female, Fluocinolone Acetonide, Humans, Hydroquinones, Male, Melanosis, Middle Aged, Ointments, Tretinoin, Treatment Outcome, Patient Satisfaction, Asian People
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