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

By Pearl E. Grimes, M.D.
Published in Lasers Surg Med 2008, 40;2:113–23
Published in Cutis 2007, 80;6:497–502

Objective

To compare 3 hydroquinone 4% creams for tolerability and clinical efficacy in the treatment of melasma.

Methods

Three creams, 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%) were studied over 12 weeks. The study observed improvements in disease severity, lesion area, pigmentation intensity and colorimetry measurements over 2-arm, split-face, right-left bilateral. Measurements were taken by a blinded evaluator, using a 9-point scale for disease severity and response to treatment and a 6-point scale for lesion area, pigmentation and symptoms of irritation. Any visible signs of irritation, such as erythema, peeling, oiliness or dryness, as well as any adverse events experienced, were noted at each visit. A Melasma Area and Severity Index (MASI) score was calculated at each visit, which took place at base, and weeks 4, 8, and 12.

Cream A and cream B was applied to each side of the face in treatment arm 1; 14 subjects with melasma were in this group. Cream A and cream C were applied in treatment arm 2; 21 subjects were enrolled in this treatment group. Creams A and B were applied twice daily for 12 weeks, and cream C was applied once daily for 8 weeks with a placebo used for the remaining 4 weeks, due to labeling restrictions which have since been lifted. Subjects were 18 years or older, clinically diagnosed with mild to moderate melasma that was relatively symmetric, and were not taking any form of hormones, not pregnant or lactating, and had not used any other form of topical bleaching agents within 4 weeks of the study.

Results

Cream A demonstrated significant improvement over cream B at weeks 8 and 12, in overall disease severity, lesion area and pigmentation intensity. At week 4, both creams had shown a significant difference over baseline, but not statistically different from each other. Cream A and C showed similar improvement over baseline in all areas measured at weeks 4 and 8; no statistically significant differences were shown between the two creams. At week 12, cream A showed continued improvement; cream C had been switched to placebo at this point so no further improvement was noted. No significant differences between the 3 creams were noted in the measurement of tolerability. All were well tolerated with a few isolated incidences of dryness and erythema.

Comments

This study supports previous findings of the importance of long-term strategies to maintain results in treating pigmentation. Cream A, containing encapsulated hydroquinone 4% and retinol 0.15%, showed to be a safe and effective for treatment of melasma. Because it is steroid free, yet still showed results equal to the steroid used in cream C, cream A should be considered an appropriate alternative for long-term treatment for melasma.

Reprint requests: Dr. Pearl E. Grimes, 5670 Wilshire Boulevard, Suite 650, Los Angeles, CA 90036.