A Comparative Study of the Safety and Efficacy of 75% Mulberry (Morus alba) Extract Oil Versus Placebo as a Topical Treatment for Melasma: A Randomized, Single-Blind, Placebo-Controlled Trial
September 2011 | Volume 10 | Issue 9 | Original Article | 1025 | Copyright © 2011
Glen Alvin MD, Nino Catambay MD, Ailynne Vergara MD, Maria Jasmin Jamora MD
Skin & Cancer Foundation (SCF), Manila, Philippines
Background: Melasma is an aesthetically undesirable skin condition which remains difficult to treat. Mulberry is a whitening agent with antioxidant properties.
Objective: To evaluate the safety and efficacy of 75% mulberry extract oil as a treatment for melasma versus placebo.
Patients and Methods: 50 patients were recruited and randomly assigned into two groups, with 25 treated with 75% mulberry extract oil and the other 25 treated with placebo. All patients had a negative repeat open application test (ROAT) to both mulberry extract and placebo. Patients were followed up regularly at four-week intervals for a total of eight weeks. The severity of the melasma was assessed using the melasma area and severity score (MASI), Mexameter reading, melasma quality of life score (MelasQOL) and any adverse events noted.
Results: The mean MASI score significantly improved from 4.076 (±0.24) at baseline to 2.884 (±0.25) at week 8 for the 75% mulberry extract oil group while the placebo group showed an improvement of a lesser magnitude. Mexameter readings for the mulberry group showed a significant drop from 355.56 (±59.51) at baseline to 312.52 (±57.03) at week 8 compared to the placebo group, whose Mexameter readings deteriorated from 368.24 (±46.62) at baseline to 372.12 (±44.47) at week 8. The MelasQOL score also improved tremendously for the 75% mulberry extract oil group, falling from 58.84 (SD: ±3.18) at baseline to 44.16 (SD: ±4.29) at week 8, unlike the placebo group that showed a less dramatic improvement from 57.44 (SD: ±4.66) at baseline to 54.28 (SD: ±4.79) at week 8. With regards to the adverse events, only mild itching was reported in four patients from the 75% mulberry extract oil group while there were 12 cases of either itching or erythema reported from the placebo group.
J Drugs Dermatol. 2011;10(9):1025-1031.
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Melasma is an aesthetically undesirable hyperpigmentation that occurs mainly on the face, but can occur on any sun-exposed area.1 Melasma is mainly found in women of reproductive age.4 People with skin phototypes III-V from regions of the world with intense sun exposure are prone to developing melasma.2,3
Melasma can be difficult to treat, with most treatments beneficial only in the short-term and carrying associated adverse effects like irritation, contact dermatitis and leukoderma.6 The current gold standard for treatment is hydroquinone.7 However, there have been reports of contact dermatitis, nail bleaching and ochronosis.8 Newer topical treatment options for melasma include lincomycin, vitamin C, soy, arbutin, linoleic acid, burner root extract, dithiaoctanediol, beta-carotene, scutellaria extract and mulberry extract.6,9 Mulberry extract has been found to contain flavinoids and anti-oxidant properties.10 Its tyrosinase-inhibiting activity is comparable to hydroquinone and kojic acid.9
The purpose of this study is to clinically evaluate the safety and efficacy of mulberry extract oil as a skin lightening agent in the treatment of facial melasma. We sought to assess the clinical response objectively by evaluating the melasma area and severity index (MASI), Mexameter readings, assessment by both the physician and a patient quality of life assessment (MELASQOL) taken at baseline and during follow ups, and noting any adverse events.