A Comparative Study of 20% Azelaic Acid Cream Monotherapy versus a Sequential Therapy in the Treatment of Melasma in Dark-Skinned Patients

Abstract

Background: Melasma is a commonly found hyperpigmentary disorder in dark-complexioned persons, which is rather difficult to treat. Azelaic acid (AZA) 20% is considered efficacious in the treatment of melasma, although the response is rather slow. It has also been combined synergistically with topical retinoic acid, where the results were satisfactory. Objective: The study was done to evaluate the usefulness of a sequential therapy of potent topical steroids +20% AZA cream versus only 20% AZA cream in the treatment of melasma. Methods: This was a prospective, single-blind, right-left comparison pilot study with (1) twice daily application of 20% AZA to one half of the face for 24 weeks and (2) a potent topical steroid, 0.05% clobetasol propionate cream, to be applied for 8 weeks only and then to be followed by 20% AZA cream only for the next 16 weeks on the other half. Concomitant use of a broad-spectrum sunscreen was also mandatory. Thirty Indian patients (25 females, 5 males), whose ages ranged from 21 to 45 years and who were not pregnant, nursing or on any concurrent therapy, completed the study. Clinical evaluation, photography and the overall response were assessed at 4, 8, 16 and 24 weeks. Results: At 4, 8 and 16 weeks, the lightening of melasma was significantly more marked on the side receiving the sequential therapy rather than the side receiving only 20% AZA cream (p < 0.001). However, at 24 weeks, although the difference was still significant (p = 0.0052), as many as 96.7 and 90% of patients of each group (sequential therapy and AZA) had good to excellent responses to treatment. The side-effects noted were mostly mild and transient and mainly local irritant effects. Conclusions: A sequential therapy of topical potent steroids +20% AZA cream can be considered as another alternative treatment for melasma, which combines the beneficial effects of both besides perhaps increasing the compliance of the patients. 20% AZA monotherapy itself is also an effective and well-tolerated therapy for melasma in dark-skinned races.

Modifying skin pigmentation – approaches through intrinsic biochemistry and exogenous agents

“…Its efficacy in treating hypermelanosis, which has been reported to be as good or even better than HQ [118], has been confirmed by several clinical studies [119].…”

Hypopigmenting agents: an updated review on biological, chemical and clinical aspects

“…In an open-label randomized study of 50 patients, 24 weeks of treatment with azelaic acid 20% and azelaic acid 20% plus tretinoin 0.05% resulted in good results in 5.3% and 34.8% of patients respectively (Zaumseil and Graupe, 1995). Sarkar et al (2002) have also studied sequential therapy of the topical steroid clobetasol propionate and azelaic acid. Ninety-seven percent and 90% of patients had excellent responses with azelaic acid plus steroid and azelaic acid, respectively.…”

“…The efficacy of a topical cream, with kojic acid, phytic acid and buthyl methoxydibenzoylmethane, in treating facial melasma in all Fitzpatrick skin types has been assessed in a doubleblind controlled comparative study (Levy et al, 2005). Sarkar et al (2002) have demonstrated that serial glycolic acid peels can significantly improve the clinical efficacy of a modified Kligman's formula. Improvement of pigmented spots has been observed in Asian women treated with daily application of 10% glycolic acid and 2% hydroquinone in association with 70% glycolic acid peels every 3 weeks (Lim and Than, 1997).…”

Treatment of melasma

“…In an open-label randomized study of 50 patients, 24 weeks of treatment with azelaic acid 20% and azelaic acid 20% plus tretinoin 0.05% resulted in excellent results in 5.3% and 34.8% of patients, respectively. 15 Sarkar, Bhalla, and Kanwar 16 have also studied sequential therapy of the potent topical steroid clobetasol propionate and azelaic acid. Thirty Indian patients with melasma had azelaic acid 20% applied to one half of the face twice daily for 24 weeks and to the other half, clobetasol propionate 0.05% for just 8 weeks followed by azelaic acid 20% for the remaining 16 weeks.…”