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A randomized, double‐blind, placebo‐controlled clinical trial on the efficacy and safety of 3% R umex occidentalis cream versus 4% hydroquinone cream in the treatment of melasma among F ilipinos
Author(s) -
Mendoza Clarisse G.,
Singzon Ivan A.,
Handog Evangeline B.
Publication year - 2014
Publication title -
international journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 93
eISSN - 1365-4632
pISSN - 0011-9059
DOI - 10.1111/ijd.12690
Subject(s) - medicine , melasma , placebo , double blind , dermatology , hydroquinone , randomized controlled trial , clinical trial , traditional medicine , surgery , alternative medicine , pathology , chemistry , organic chemistry
Background Melasma is a commonly acquired hyperpigmentation symmetrically distributed on the face, neck, and arms. The skin‐lightening properties of R umex occidentalis make it a therapeutic alternative to the reference standard treatment of hydroquinone ( HQ ). Objectives This study was conducted to evaluate the safety and efficacy of 3% R . occidentalis cream versus 4% HQ cream in the management of epidermal and mixed melasma. Methods This was a randomized, double‐blind, placebo‐controlled trial. Forty‐five subjects with epidermal and mixed melasma were recruited to compare 3% R . occidentalis cream, 4% HQ cream, and placebo cream applied twice daily for eight weeks. Changes in pigmentation were measured every two weeks using the M elasma A rea S everity I ndex ( MASI ) and a mexameter. Adverse events were noted on every visit. Patient and investigator global evaluations were performed at the end of the study. Results Overall mean MASI and mexameter readings in the three groups decreased from baseline to week 8. The greatest decline in score from weeks 2 to 6 was achieved by the HQ group, followed by the R . occidentalis group. By week 8, the R . occidentalis group showed a greater mean ± standard deviation decline in MASI and mexameter readings from baseline ( MASI : 0.60 ± 0.86; mexameter: 50.56 ± 25.63) than the HQ group ( MASI : 0.55 ± 0.62; mexameter: 45.89 ± 47.83). The efficacy of R. occidentalis cream and HQ cream were assessed as similarly favorable by both study subjects and investigators. Conclusions R umex occidentalis 3% cream is a safe and effective skin‐lightening agent for melasma and is comparable in efficacy with 4% HQ cream.