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Pharmacology and therapeutics, clinical trial - Dermage

Pharmacology and therapeutics, clinical trial - Dermage

Pharmacology and therapeutics, clinical trial -

Blackwell Oxford, IJD International 0011-9059 Blackwell 41 UK Science, Journal Ltd 2002 of Dermatology Pharmacology and therapeutics, clinical trial Skin Haddad whitening et al. complex and hydroquinone in melasma treatment A clinical, prospective, randomized, double-blind trial comparing skin whitening complex with hydroquinone vs. placebo in the treatment of melasma Alessandra Lima Haddad, MD, Luiz Fernando Matos, MD, Flavia Brunstein, Lydia Masako Ferreira, MD, PhD, Ademir Silva, and Divaldo Costa Jr From Escola Paulista de Medicina, Federal University of São Paulo, São Paulo, Brazil UNIFESP-EPM Correspondence Alessandra Haddad, MD Rua Dr Alceu de Campos Rodrigues 229 cj. 711/712 São Paulo SP Brazil E-mail: alehaddad@aol.com Introduction Melasma is a frequent clinical condition, characterized by a slowly progressive symmetrical hypermelanosis with an irregular coloration, ranging from light brown to gray and dark brown, which affects patients of all races and both sexes, with 1 a greater frequency in females (90%) due to pregnancy and the use of oral contraceptives. Although less frequent, other factors involved in the pathogenesis deserve to be mentioned, such as genetic influences, exposure to ultraviolet rays, cosmetics, phototoxic drugs, and anticonvulsants. Melasma can be classified clinically into: (i) epidermal: light brown color – melanin in the basal and suprabasal layer of the epidermis; (ii) dermal: grayish coloration – melanophages Abstract Objectives To compare, in a double-blind, randomized, prospective study, the clinical improvement of hyperpigmentation in 30 patients with melasma using hydroquinone or skin whitening complex topically on one side of the face vs. a placebo cream on the other. The study was performed during the period November 2000 to March 2001 at the Federal University of São Paulo, Escola Paulista de Medicina. Methods Thirty patients received three tubes of cream and were divided into two groups: group 1, one tube containing hydroquinone 4% cream and one tube containing placebo to be applied to opposite sides of the face at night, and standardized sunscreen [sun protection factor (SPF) 25] for daily use; group 2, one tube containing skin whitening complex 5% cream and one tube containing placebo to be applied to opposite sides of the face at night, and standardized sunscreen (SPF 25). All of the tubes had the same appearance and the creams had the same characteristics. The only person who knew what was being used by each patient on each side of the face was the pharmacist. A professional photographer took photographs before and after treatment, which lasted for 3 months. Clinical evaluation was performed by two independent observers and by the patients themselves. Statistical evaluation was by the chi-squared and kappa methods. Results Twenty-five patients completed the study, with an overall improvement of 72% in comparison with placebo. Group 1 (hydroquinone and placebo) presented an improvement of 76.9% with 25% side-effects, and group 2 (skin whitening complex and placebo) presented an improvement of 66.7% with 0% side-effects. Conclusions Both depigmentation agents were useful in the treatment of melasma. The hydroquinone group presented more collateral effects than the skin whitening complex group. Considering that the patients showed Fitzpatrick skin types IV to VI and the study was conducted in the summer, skin whitening complex seems to be an excellent choice for the treatment of melasma. loaded with melanin in the papillary dermis; (iii) mixed: dark brown (iv) indeterminate or not apparent; occurs in black-skinned patients in visible in daylight but is not visible under wood’s lamp examination. In all subtypes, there is a moderate increase in the number of melanocytes and also in 2 the cellular activity. The management of melasma is a challenge, as there is no gold standard treatment and recurrences are common. The principles which govern therapy are based on the following strategies: (i) sunscreen use; (ii) inhibition of the exacerbated activity of melanocytes; (iii) removal of melanin; (iv) dispersion of melanin granules. Hydroquinone, a hydroxyphenol that blocks the synthesis of melanin by inhibiting the tyrosinase enzyme, is the © 2003 The International Society of Dermatology International Journal of Dermatology 2003, 42, 153–156 153

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