Evaluation of the Efficacy and Safety of A New Pigment Correction Cosmetic Protocol in Caucasian Women with Melasma

Abstract

Melasma is one of the most prevalent acquired pigmentation disorders, especially among women due to its hormonal background. There is a wide variety of therapeutic alternatives available for its treatment given its multifactorial origin and complexity. Cosmetic protocols based on depigmenting agents remain one of the cornerstones of melasma treatment. Aim: To evaluate the efficacy and safety of a new cosmetic pigment correction protocol in the treatment of melasma in Caucasian women. Methods: A single-blind, prospective, single-center study was conducted in 20 women between 25 and 65 years of age, phototypes II-IV with mildmoderate facial melasma. For 90 days patients applied a sunscreen and moisturizing cream in the morning and a pigment correction protocol at night consisting of a skin retinization regime combining two formulations with Retinsphere® technology. (Neoretin DC Ultra emulsion and Neoretin DC transition cream). Treatment results were evaluated by clinical assessment, Observ® photography and non-invasive instrumental measurements such as the erythema and melanin index by Mexameter. The Melasma Area and Severity Index (MASI) were recorded, and patients completed both a quality of life questionnaire (MELASQoL) and a subjective evaluation. Results: MASI score was significantly reduced at all study visits, with a significant reduction in the area and severity of melasma already observed at 30 days and a 48% reduction at the end of treatment. In the opinion of the investigator and patients, some degree of improvement was reported in 95% of patients at the end of treatment and neither patients nor the investigator reported worsening of melasma at the end of treatment as compared to baseline. The degree of melasma improvement observed by patients increased progressively and significantly from day 45 onwards, reaching an improvement of almost 70% at the end of the treatment. The adverse effects evaluated, (peeling, erythema, burning, tightness, irritation, and itching) increased gradually, being higher at T45 and T60, coinciding with the greater frequency of application of the formulations. Effects were however transient and in no case reached statistical significance or required treatment discontinuation. Conclusion: The cosmetic pigment correction protocol under study appears to be an effective therapeutic option for the treatment of melasma. The retinization regime, which consisted in the gradual application of the more powerful formulation alternated with a transition formulation, made it possible to achieve both efficacy and good tolerability to the therapeutic regimen.