Triple combination cream improves melasma

February 1, 2008

Cutaneous melasma is a common dermatologic disease, occuring more frequently in Asian and Hispanic women with dark skin and of childbearing age. A recent study with a triple combination cream confirms significant clinical success in the treatment of facial melasma.

Key Points

Porto Alegre, Brazil - A recent study shows that a triple combination cream, consisting of hydroquinone 4 percent, tretinoin 0.05 percent and fluocinolone acetonide 0.01 percent, achieves far superior results in the treatment of facial melasma compared with hydroquinone 4 percent cream used alone, according to a Brazilian expert.

Tania Ferreira Cestari, M.D., department of dermatology, Federal University of Rio Grande do Sul - Hospital de Clinicas de Porto Alegre, conducted a randomized, controlled, open-label clinical trial on 120 patients with facial melasma, comparing the clinical efficacy of the triple combination cream and hydroquinone 4 percent cream used as a monotherapy.

Sixty patients received the triple combination cream (hydroquinone 4 percent, tretinoin 0.05 percent and fluocinolone 0.01 percent) once a day, and 60 patients received hydroquinone 4 percent cream (Claripel, Stiefel) twice a day. Patients treated their facial melasma for a total of eight weeks, and they were followed at weeks zero, two, four, six and eight.

"Our results were remarkable, showing that the patients who applied the triple combination cream had significantly better clinical results at follow-up weeks four, six and eight, compared to those patients who used the hydroquinone cream alone," Dr. Cestari says.

"Lesions were approximately equivalent to the surrounding skin in 35 percent of all of the triple combination-treated patients, compared to only 5 percent of those patients who only used the hydroquinone cream.

"Furthermore, overall improvement of more than 75 percent was achieved by 73 percent of the patients using the triple combination cream, compared to only 49 percent of the patients using the hydroquinone cream," Dr. Cestari says.

Results not surprising

Dr. Cestari says the most common adverse events recorded by patients included erythema, a burning sensation and desquamation, but these events were similar in both groups.

Other adverse events, recorded at the end of the study, included facial telangiectasia in nine patients from the triple combination group and five patients from the hydroquinone group. Out of the 120 patients who were admitted in the eight-week study, only one patient in the hydroquinone monotherapy group dropped out at week six due to a non-drug related adverse event.

"The results of this study clearly demonstrate that the treatment effect of the triple combination cream was significantly more effective from the fourth week of therapy onward than the hydroquinone cream used as a monotherapy for the treatment of moderate-to-severe facial melasma," Dr. Cestari said.

According to Dr. Cestari, the results from this study were not very surprising, as similar studies found that a combination of hydroquinone and fluocinolone acetonide is more effective in the treatment of melasma than hydroquinone alone.

"Some physicians have expressed concern regarding the risk of skin atrophy following the long-term topical application of corticosteroids. In our study, the absence of skin atrophy in the patients who applied the triple combination may be related to the presence of retinoic acid, preventing corticosteroid-induced atrophy without lessening the anti-inflammatory effect. 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 percent is a class IV corticosteroid or medium-to-low potency," Dr. Cestari says.