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İngiltere’de yayınlanan prestijli bir dergi Journal Of Cosmetic Dermatology (kozmetik dermatoloji dergisi) de yayınlanan’ melasmada 3lü kombinasyon tedavisinin tekli tedaviden daha üstün olduğunu gösteren bir çalışma. Ülkemizde yaptığımız gibi 3 ayrı ürünü farklı zamanda kullanmak yerine üç molekülü birleştirip bir ürün geliştirmişler. Tabi bu bizim üçünü aynı
kutuda karıştırmamıza benzemez.

Original Contribution

A comparison of triple combination cream and hydroquinone 4% cream for the treatment of moderate to severe facial melasma

Tania Ferreira CestariMD ¹ ¹Department of Dermatology, Federal University of Rio Grande do Sul – Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil,
Karime Hassun, MD ² ²Department of Dermatology, Federal University of São Paulo, São Paulo, Brazil ,
Alexandre Sittart, MD ³ ³Hospital do Servidor Publico Estadual, São Paulo, Brazil , &
Maria de Lourdes Viegas, MD ⁴ ⁴Hospital da Lagoa, Rio de Janeiro, Brazil

¹Department of Dermatology, Federal University of Rio Grande do Sul – Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
²Department of Dermatology, Federal University of São Paulo, São Paulo, Brazil
³Hospital do Servidor Publico Estadual, São Paulo, Brazil
⁴Hospital da Lagoa, Rio de Janeiro, Brazil

The authors received payments for the recruitment of subjects for this clinical trial. None of the authors has any financial interest in Galderma Laboratories to disclose.

Correspondence: Tania Cestari, MD, Rua Mostardeiro 333, conjunto 415, Moinhos de Vento, CEP 90430-001, Porto Alegre/RS, Brazil. E-mail: Bu mail adresi spam botlara karşı korumalıdır, görebilmek için Javascript açık olmalıdır

Keywords : facial melasma, fluocinolone acetonide, hydroquinone, stable fixed combination, topical therapy, tretinoin

The aim of this study was to compare the efficacy and safety of a triple combination (TC) cream and monotherapy with hydroquinone (HQ) cream in the treatment of moderate to severe facial melasma. A total of 120 patients applied TC cream once daily or HQ cream twice daily for 8 weeks. Evaluations included static global severity assessment of melasma, improvement of melasma over time, local tolerability, and adverse events. TC cream was significantly more effective than HQ cream from week 4 onwards: lesions were approximately equivalent to the surrounding skin in 35% of all TC-treated patients, compared to 5% of those who used HQ cream (P = 0.0001). Improvement of more than 75% was achieved by 73% of TC cream patients and 49% of HQ cream patients (P = 0.007). The incidence of adverse events (erythema, burning sensation, and desquamation) was similar in both groups. No patient dropped out of the study because of drug-related adverse events. TC cream was more effective than the HQ cream for the treatment of moderate to severe facial melasma. Both products had similar safety profiles

Discussion

This was a multicenter, open-label, randomized, 8-week clinical trial comparing the once-a-day application of TC cream with the twice-a-day application of HQ cream in the treatment of moderate to severe melasma of the face.

Significantly more patients treated with TC cream had their melasma cleared at week 8 (P < 0.0001; 35% vs. 5.1% with HQ cream) and significantly (P < 0.0007) more patients treated with TC cream showed improved clearance of melasma at the same time point. Thus, the results of this study demonstrated that the treatment effect of TC cream was significantly more effective from week 4 on than HQ cream at treating moderate to severe facial melasma.

These results further confirm findings of other authors that a combination of HQ with fluocinolone acetonide and a corticosteroid is more effective than HQ alone. ¹⁵ Furthermore, the results of the present study are in accordance with findings made in another 8-week study showing that TC cream was significantly more effective in achieving total clearing of melasma than any of its dyads (i.e., dual combinations: HQ + RA, HQ + FA, or FA + RA). ¹⁸

Some authors have expressed concerns regarding the risk of telangiectasia and skin atrophy following long-term topical administration of corticosteroids. ⁷ A total of 14 cases of telangiectasia were reported at the end of treatment: nine patients (15%) treated with TC cream relative to five patients (9%) treated with HQ cream. The incidence of this adverse event is possibly related to the fact that certain patients applied the studied drugs to the whole face, hence exposing a greater surface and is not related to the treatment of melasma using the medications. However, none of these events resulted in the discontinuation of the study. Previous clinical long-term investigations confirmed that the incidence of telangiectasia with TC cream did not exceed 4% of the total study population. ¹⁹

The absence of skin atrophy with TC cream may be related to the presence of RA, preventing corticosteroid-induced atrophy without lessening the anti-inflammatory effect, as proposed by Kligman et al. and McMichael et al. ^16,17 Furthermore, the relatively low incidence of side effects commonly associated with corticosteroids may be due to the fact that fluocinolone acetonide in a concentration of 0.01% is a medium to low potency (Class VI) corticosteroid.

Local adverse events, such as erythema, burning sensation, and desquamation, were equally distributed in both groups.

In conclusion, an 8-week treatment with a once-a-day application of TC cream was shown to be significantly more effective (73% vs. 49%) than a twice-a-day application of HQ in the treatment of moderate to severe facial melasma, while showing similar and good safety profiles.

SON PARAGRAFI ÇEVİRİYORUM: YÜZDEKİ ORTA VE ŞİDDETLİ MELAZMANIN 8 HAFTALIK GÜNDE 1 DEFA UYGULANAN 3LÜ KOMBİNE KREM TEDAVİSİ ,GÜNDE 2 DEFA UYGULANAN HİDROKİNONDAN (ülkemizde expigment de var) BELİRGİN OLARAK DAHA ETKİLİ OLDUĞU GÖSTERİLMİŞTİR.

KARŞILAŞTIRMASI YAPILAN HER 2 İLAÇ YAN ETKİLER AÇISINDAN GÜVENLİ BULUNMUŞTUR.

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