French maritime pine bark extract (pycnogenol) in association with triple combination cream for the treatment of facial melasma in women: a double-blind, randomized, placebo-controlled trial.
J Eur Acad Dermatol Venereol. 2020 Aug 25. Epub 2020 Aug 25. PMID: 32841433
Paula Basso Lima
BACKGROUND: Melasma can be recalcitrant to treatment, and relapses are common. Pycnogenol has been reported to be effective in treating melasma.
OBJECTIVE: To compare the efficacy, safety, and tolerability of 75 mg pycnogenol taken orally twice a day versus a placebo, in association with the triple combination and broad-spectrum sunscreen for the treatment of facial melasma.
METHODS: A randomized, double-blind, parallel, placebo-controlled study was conducted on 44 women with facial melasma in a single centre from May 2019 through November 2019. Patients with melasma were randomly assigned to orally take 75 mg pycnogenol (PYC) or a placebo (PLAC) twice a day for 60 days. Both groups also received tinted sunscreen (SPF 50; PPD 17) for daytime use and a topical triple combination at bedtime. The primary outcome was a change from the baseline mMASI score. Secondary outcomes were improvements in the patients' quality of life (MELASQoL), colorimetric indices, and Global Aesthetic Improvement Scale (GAIS).
RESULTS: All participants completed the trial. The mean (SD) age of the participants was 39 (7) years, and 91% were phototypes III-IV. Both groups exhibited a reduction in mMASI scores, MELASQoL scores, and colour contrast (p<0.01). The mean (CI 95%) reductions of the mMASI scores were 49% (36-61%) for PYC and 34% (16-47%) for PLAC. The reductions in mMASI scores and colorimetric contrast were superior for the PYC group (p<0.05). The analysis of GAIS resulted in an improvement of 86% (CI 95% 68-96%) for the participants in the PYC group and 55% (CI 95% 32-73%) for those in the PLAC group. There were no adverse effects related to oral treatment.
CONCLUSION: Pycnogenol is well-tolerated and increases the effectiveness of broad-spectrum sunscreen and the triple combination in the treatment of facial melasma in women.