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.
RCT Entities:
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.