Development of polymeric microneedles for treatment of melasma

Abstract

Melasma is a common and acquired hyperpigmentation disorder that affects approximately 7.2 million women in Brazil during their childbearing and reproductive age. It is characterized by irregular light to dark brown spots on the face, which negatively impacts the patient’s well-being and quality of life. Although its pathogenesis remains unclear, several etiological factors have already been identified as risk factors for the development of melasma, including exposure to sunlight and visible light, genetic predisposition, pregnancy and use of exogenous hormone (combined contraceptives and hormone replacement therapy). Although its global prevalence is still unknown, it is estimated that 9-50% of the population exposed to the risk factors have melasma. In addition, 8-34% of women who use exogenous hormone and 10-70% of pregnant women, develop melasma in the world. Unfortunately, among the treatments currently available, most produce inconsistent and generally unsatisfactory results in the long term, in addition to being, for the most part, irritating and aggressive to the skin. Therefore, given the negative impact of melasma on quality of life and the clinical and therapeutic challenges associated with it, the search for a more effective alternative with a sustained and long-term effect for patients with this frustrating and therapeutically challenging disorder has been one of the main focus of the global Pigmentation Disorders Treatment (TDP) market. During the Phase I of this project, a prototype containing depigmenting actives in a biodegradable and biocompatible polymeric matrix was developed, which was shaped in microneedles (MNs) with adequately skin penetration property. Therefore, this PIPE phase II project is aimed to evaluate the in vitro and in vivo safety and efficacy of this MNs for the treatment of melasma. After two years, it is expected to obtain a more effective, painless and minimally invasive treatment for melasma and other skin hyperpigmentation disorders, overcoming the limitations of conventional therapies. (AU)