A A prospective, observational study of Cosmelite NextTM therapy to evaluate the efficacy and safety of a novel plant-derived combination in the treatment of Melasma at dermatological centers in Hyderabad.

Abstract

Background and objectives: Melasma, an acquired condition of skin hyperpigmentation, is adifficult condition to treat. This study was conducted to evaluate the efficacy and safety of a novelplant-derived combination for Melasma, Cosmelite NextTM, containing a combination of silymarin(0.7%), soy Isoflavones (0.25%), pTerowhite (0.10%), kojic acid (2%), ascorbic acid (1%),niacinamide (4%) and mandelic acid (3%).

Material and Methods: This was an open-label, single-arm, prospective, multi-centre observational study at dermatological centres in Hyderabad, India.Patients diagnosed with Melasma of either gender and skin type consistent with Fitzpatrickphototypes I-IV categories were enrolled across Hyderabad, India. Outcomes included melasma areaand severity index (MASI) score, lesion score, physician's global assessment (PGA) and patient'sglobal assessment score.

Results: In terms of the primary variable, the change from baseline scoreto 12 weeks in MASI was statistically significant (mean difference 1.46 (95% CI 1.39–1.52);p=0.001), and the decreasing trend was observed from week four onwards. Lesion scores alsodecreased from the baseline to week 12, with a mean difference of 1.46 (95% CI 1.39–1.52;p=0.001). At the end of the study period, 91% of the patients showed some improvement in thePGA, whereas 93% showed improvement in the patients' global assessment score.

Conclusion:Cosmelite NextTM was safe and efficacious, and the improvements in assessment scores were seenas early as four weeks. The novel combination could be an effective alternative to conventionaltreatments such as hydroxyquinone, retinoids and steroid preparations.