Assessment of the efficacy and tolerance of a new combination of retinoids and depigmenting agents in the treatment of melasma
October 21, 2014
María T. Truchuelo1, Natalia Jiménez1, María Vitale2, 1Department of Dermatology, University Hospital Ramón y Cajal, 2Medical Department, IFC, Madrid, Spain
Melasma is a common hyperpigmentation disorder which mainly affects women with a high phototype and often remains active for several years, being associated with a considerable psychological impact. The exact aetiology is unknown but several factors have been suggested to promote it, such as genetics, ultraviolet and visible radiation, and hormone alterations. The management of melasma is often challenging, because it is very resistant to treatments and requires long-term therapeutic protocols. Conventional treatment includes depigmenting products, such as hydroquinone (HQ), retinoids, mequinol, azelaic acid, arbutin, kojic acid, etc., which exert their action at different stages of melanogenesis. In addition, avoidance of aggravating factors is strongly indicated.
Combination therapy is usually prescribed, with a typical association of HQ and retinoic acid. However, HQ’s safety has been questioned in certain cases, and prolonged use may lead to adverse effects such as depigmentation and ochronosis, so it cannot be considered as a golden standard. In the search for safer alternatives, a treatment regimen based on RetinSphere® technology has been designed (serum & gelcream). It incorporates two topical retinoids: retinol glycospheres and hydroxypinacolone retinoate, which directly interacts with the retinoic acid receptor but does not induce irritation. Additionally, the products include other depigmenting active ingredients, such as N-acetylglucosamine, kojic acid and niacinamide, among others, and photoprotective ingredients (SPF 50). The objective has been to create a treatment regimen which may reduce or even substitute the use of HQ in the management of melasma patients.
To determine the efficacy and safety of a new combination of retinoids and depigmenting agents in the improvement of melasma.
Prospective, double-blind, vehicle-controlled and randomized study in 30 adult patients with melasma, and without any concomitant diseases or treatments. The active treatment (Neoretin® gelcream and serum-IFC Pharmaceuticals) was applied twice daily during 3 months on one side of the face, and vehicle gelcream with SPF 50 and vehicle serum on the other. The observation period was 3 months, organized into three visits at baseline (T0), one and a half months (T1) and three months (T2). Standardized photographs were taken using Reveal® System with RBX technology at each visit. The main variable to determine the efficacy was the improvement of the hemifacial Melasma Area Severity Index (MASI).
28 patients (27 females and 1 male; average age: 39 years) completed the study. The photographic analysis with RBX technology demonstrated that 89% of the patients showed some degree of improvement on the side treated with the products, compared to only 56% on the vehicle side (p = 0.005). The reduction of the MASI score at 3 months of treatment on the side treated with the products was 74% compared to 55% on the side that received vehicle (p = 0.009). No remarkable side effects were detected, in spite of a significant percentage (67%) of patients included in the study citing a history that could be indicative of sensitive skin.
This new treatment regimen based on the combination of retinoids and depigmenting agents proved to be effective in reducing melasma hyperpigmentation, while being safe and not yielding any side effects after 3 months of treatment.