A randomized, double-blind, placebo-controlled clinical trial on the efficacy and safety of 3% Rumex occidentalis cream versus 4% hydroquinone cream in the treatment of melasma among Filipinos.

BACKGROUND

Melasma is a commonly acquired hyperpigmentation symmetrically distributed on the face, neck, and arms. The skin-lightening properties of Rumex 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 Melasma Area Severity Index (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

Rumex occidentalis 3% cream is a safe and effective skin-lightening agent for melasma and is comparable in efficacy with 4% HQ cream.