Skin Diseases & Skin Care

Novel Supplement with Phenolic Compounds for Treatment of Melasma: Double Blind Placebo Controlled Trial Safety and Efficacy Evaluation

Melasma (or chloasma) is a chronic acquired dyschromia that is distributed mostly on sun-exposed areas of the face and neck. While melasma is seen in both sexes, women are most commonly word originates from the Greek root “melas,” which means black and refers to its dark clinical presentation.  pathogenesis of melasma is not fully understood. It includes genetic factors, exposure to UV radiation, hormonal contraceptives, photosensitizing drugs, inflDmmDtor\ processes of the skin, and stressful events [1,2]. Melasma has a profound impact on appearance; patients commonly report feelings of shame and low self-esteem and a lack of motivation to go out. Population incidence of melasma is not precisely known; however, higher prevalence is reported among East Asians, Indians, Pakistani, Middle Eastern, and Mediterranean-African populations. In the Americas, it is common in intertropical areas with greater exposure to ultraviolet radiation [3]. Sunscreen with a high protective factor may reduce the intensity of the disease in up to 50% of cases; oxidative stress plays a major role in the biological acts produced by UVA and UVB radiation [4]. the disease is triggered by pregnancy or oral contraceptives in approximately 40%-50% of female patients. Improvement in the non-transient erythema score was observed. At 90 days, the non-transient erythema score significDntl\ (p Current treatments involve the elimination of potential causative factors and diligent use of broad-spectrum sunscreen products that regulate the pigmentation pathway.  also include external application of hypopigmented agents (tretinoin/hydroquinones), chemical peels and laser therapy and administration of vitamin C and/or vitamin E and in some countries — intravenous injection of vitamin C and/or glutathiones. Furthermore, clinical studies have documented protective acts of carotenoid phytonutrients against UVR-related skin damage. Recently, a product with enhanced bioavailability of monomeric phenolic compounds was clinically evaluated. Its complex addresses multiple pathways in pigmentation and UV exposure management and was shown to be the safe and active goal of this study was to investigate NanoMD Bright™ (Boston Sante, Inc., Boston, MA), a unique complex of monomeric phenolic compounds (pine bark extract) and specific carotenoids with bioavailability enhanced by utilizing nanotechnology for the control of melasma. Forty subjects with Fitzpatrick skin types III-V in good general health between the ages of 22 and 59 are presented in these pages. 20 subjects used the supplement (in tablet form) orally once a day over 12 weeks, with evaluations at the baseline period, at 60 days and 90 days and 20 subjects used the placebo (in tablet form) orally once a day over 12 weeks, with evaluations at the baseline period, at 60 days and 90 days.  modified melasma area and severity index (ASI) tool was used for evaluating melasma. Melasma was assessed by a blinded evaluator in four sections of the face (forehead, right malar,  malar, and chin).  overall hyperpigmentation scale tool was used by a blinded evaluator for evaluating hyperpigmentation. Additionally, all subjects completed a questionnaire using the 5-point Likert Scale evaluating their satisfaction with the product at 90 days. Progressive improvement in melasma (clinical trial primary objective) was observed. At 60 days, the MSI score improved by 49%, and at 90 days it improved by 57%. In the placebo group, the MSI score improved by 10% at 60 days and 11% at 90 days. In the non-placebo treatment group, the plateau for these parameters was not seen at 90 days; subjects showed an 8% increase in MSI reduction. was a greater decrease in MAI for the supplement group vs. placebo (-3.28 for the active arm vs. -0.73 for the placebo arm. There are several treatments available to control melasma. Results from this study suggest that this oral supplement is active in the treatment and management of melasma. An optimal supply of antioxidant micronutrients ensures an increased basal dermal defense against UV irradiation and contributes toward long-term protection and maintenance of skin health [6,7].  the study provides a strong rationale for the use of a product that uses a complex of monomeric phenolic compounds and selected carotenoids enhanced by nanotechnology for the control of melasma and suggests such products may provide an alternative treatment for overall hyperpigmentation and non-transient erythema. Conclusion Consistent, statistically significant reductions in melasma, as measured by MSI scores, overall hyperpigmentation, and nontransient erythema scores were achieved while meeting patient expectations at the 90-day follow-up evaluation point when compared to placebo.  product was well tolerated, with no reports of adverse events or side effects. Consistent, statistically significant reductions in melasma, as measured by MSI scores, overall hyperpigmentation, and non-transient erythema scores were achieved while meeting patient expectations at the 90-day follow-up evaluation point when compared to placebo. Results from this clinical trial suggest that this oral supplement is an effective treatment for melasma and may provide an alternative treatment for overall hyperpigmentation and non-transient erythema while meeting the expectations of patients. The product was well tolerated, with no reports of adverse events or side effects.

Author(s):

Jeanine Downiel and Nurul Ain Abdullah

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