An Efficacy Study of 3 Commercially Available Hydroquinone 4% Treatments for Melasma

Melasma is a common disorder of hyperpigmentation typically characterized by relatively symmetric brown or gray-brown patches on sun-exposed facial areas. Treating melasma is challenging because of the prolonged time to response and the substantial relapse rate when therapy is discontinued. The objective of this 12-week study was to compare the clinical efficacy and tolerability of 3 hydroquinone 4%–containing creams in the treatment of melasma. The 3 creams were cream A (microencapsulated hydroquinone 4% and retinol 0.15% with antioxidants); cream B (hydroquinone 4% and retinol 0.3% with antioxidants); and cream C (fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%). This 2-arm, split-face, right-left bilateral, evaluator-blinded study compared cream A and cream B in treatment arm 1, and cream A and cream C in treatment arm 2. Evaluator-blinded study assessments were conducted at baseline and weeks 4, 8, and 12. Results from treatment arm 1 demonstrated that at weeks 8 and 12, treatment with cream A showed statistically significant improvements over cream B in the efficacy assessments of overall disease severity (week 8, P=.005; week 12, P=.028), lesion area (week 8, P=.005; week 12, P=.003), pigmentation intensity (week 8, P=.012; week 12, P=.012), and Melasma Area and Severity Index (MASI) score (week 8, P=.002; week 12, P=.012). Results from treatment arm 2 demonstrated that at weeks 4 and 8, treatment with cream A was similar to cream C in the efficacy assessments of overall disease severity, lesion area, pigmentation intensity, MASI score, and global evaluation of response to treatment. At week 12, cream A continued to demonstrate sustained improvements in each of the above efficacy assessments; however, cream C showed a decrease in improvement of these efficacy assessments because subjects were switched to placebo for the last 4 weeks of treatment. All 3 treatments were well-tolerated. These data confirm previous findings that the unique delivery system of microencapsulated hydroquinone 4% and retinol 0.15% with antioxidants is safe and effective for use in treating melasma, and the data show that this novel nonsteroidal product should be considered when weighing long-term treatment options.