This study shows topical melatonin improves the clinical signs of skin again by use of Melatosphere™, which is a new lipid-based delivery system used in topical formulations. title Isvanti-Aging Efficacy of Melatonin-Based Cream. There are 31 references.

Introduction: There are several studies published in support that skin is a complete and independent melatoninergic system. Mel Receptors (MT1, MT2 and MT3) are presented in both human and animal skins. Release of Melatonin from the pineal gland activates MT1 and MT2 receptors. Mel has both direct and indirect antioxidant properties and it is an active mitochondrial, cytoprotective and antioxidant molecule. Mel can increase the production of antioxidative enzymes like superoxide dismutase. It also increases the effect of Sirtuin 1, an anti-degenerative molecule. Several studies are in support of the concept that the use of Melatonin before UV irradiation can prevent the skin from sun damage and can also reverse the damage caused by the sun (UVB). Mel reduces hyperpigmentation processes through direct and indirect actions. Mel can easily penetrate through stratum corneum and acts as an anti-ageing molecule. Melatosphere™ is a new delivery system able to improve stability and skin penetration of Mel when used in a topical cream. Melatosphere™ is a cream containing glycerin and 0.1% melatonin in oleospheres of Opuntia ficus Indica seed oil and Persea gratissima oil. No clinical studies, using objective instrumental data, are available so far regarding the positive effect of Melatosphere™ cream in improving coarse wrinkles in women with mild-to-moderate skin ageing.

Methodology: In this study, fifteen women were enrolled after providing their informed consent. These women have mild to moderate facial skin ageing problems. These women also consent to the publication of any pictures. All the women were above 45 years of ages and the inclusion criteria were women with moderate-severe facial skin ageing (Glogau score of 2–4). All the women with any acute or chronic skin conditions, which could interfere with the parameters of evaluation and a positive history of allergic contact dermatitis to any of the component of the tested cream were excluded from this study. This trial was approved in February 2018 by the local institutional review board (IRB; Independent Ethical Committee, c/o Derma Medica, Modena, Italy). The study was carried out by following the ethical principles of the Declaration of Helsinki and consistently with the Good Clinical Practice (GCP) regulatory requirements. A Melatosphere™ cream was prescribed to all 15 women and they applied this cream twice daily for two consecutive months and compliance was evaluated by collecting the returned used cream tubes at the last visit. ANTERA 3D contains a camera for image acquisition and software for analysis of the skin which can shoot any part of the body and measures an area of 3136 mm2 (56 × 56 mm). With the help of An ANTERA 3D two skin analysis was done, first was at baseline and second was on the final visit. This skin analysis was used for the assessment of coarse and fine wrinkles of the periorbital area and melanin contents. The skin topography and the chromophore concentration are derived from the spatial and spectral analysis of the acquired image data, obtained by illuminating the skin with LEDs of different wavelengths from different directions. On baseline visit, the target area was defined and ANTERA 3D uses to analyze the differences between these images and reconstruct the surface in two and three dimensions. ANTARA 3D images can be used to evaluate skin colour, wrinkles, texture, melanin, haemoglobin, pores, depressions, and elevation. An evaluator-blinded Investigator Global Assessment of skin elastosis, roughness, level of dyschromia, skin dryness and the presence of actinic damage was also performed at the same time points using a 4-grade score from 0 (no sign) to 3 (severe sign). Statistical analysis was performed using GraphPad Statistical Software (GraphPad Software, Inc., Version 5, La Jolla, CA, USA). Continuous variables were expressed as mean ± standard deviation (SD). As indicated by the way this was a pilot study, not a formal sample size calculation was performed. We decided to enrol at least 15 subjects.

Data & Result:

This study was conducted in an outpatient Drema-aesthetic clinic (Italy) between March 2018 and September 2018. All 15 women completed the study. At baseline, the mean (SD) IGA score was 8.2(1.0). After 2 months there was an improvement and the IGA score significantly dropped to 4.2(1.4) (a 49% reduction) (P=0.0007; Wilcoxon test). While comparing the two, baseline and after 2 months evaluation, ANTERA 3D showed a significant reduction in coarse, fine and periorbital wrinkles volume in the target area of - 31%, -18% and -17% respectively. Target area coarse wrinkles volume decreased from 25.7 mm3 to 17.8 mm3. Target area fine wrinkles decreased from 9.0 mm3 to 6.0 mm3. Melanin content was also reduced significantly by 17% (Figure 5, a and b), from 0.6(0.03) to 0.5(0.03)

Discussion: This paper explains the anti-ageing effect of topical melatonin. This primary trial was evaluated clinically. In this trial 15 women aged more than 45 years with mild to moderate facial skin ageing (Glogau score ≥2) were participated and treated with topical melatonin for over a period of two months. Mel has both direct and indirect antioxidant properties and it is an active mitochondrial, cytoprotective and antioxidant molecule. Skin is a complete and independent melatoninergic system and can produce and metabolize melatonin and presents with specific receptors for melatonin (MT1, MT2 and MT3). In the skin level, Mel is also a potent protecting molecule for mitochondria. Mitochondrial functional activity declines with age, mainly due to chronic and cumulative oxidative damage to the skin. That why Mel protective action could slow down the ageing process. Mel can increase the production of antioxidative enzymes like superoxide dismutase. It also increases the effect of Sirtuin 1, an anti-degenerative molecule. There are several studies are in support of the concept that the use of Melatonin before UV irradiation can prevent the skin from sun damage and can also reverse the damage caused by the sun (UVB). Topical melatonin cream (day and night products) improves the hydration and tonicity of the ageing skin of women, with a significant reduction in skin roughness, reduces the wrinkles and improves clinical signs of skin ageing of the face. In our trial, we evaluated the anti-ageing effects of melatonin cream by means of a computerized, operator-independent skin analysis system. The results of the present trial are promising and show that topical melatonin can significantly reduce coarse and fine wrinkles. Interestingly, it also reduces melanin content in the target area. The discovery of Mel by Lerner et al in 1958 was characterized by the fact that this “pineal factor” was able to lighten melanocytes. Some limitations should be taken into account in evaluating our results. We performed an open, non-controlled trial. To increase the internal validity of the trial results, we used an objective procedure to evaluate the efficacy of the tested product (skin wrinkle profilometry and melanin content). Photodamaged skin is characterized by the presence of coarse and fine wrinkles, hyper and hypopigmentation, roughness and sallowness. The ANTERA 3D CS device could measure all these parameters in a reproducible and sensitive way. We conclude that the Topical melatonin vehiculated in Melatosphere improves the signs of skin ageing evaluated clinically and instrumentally in women with mild to moderate skin ageing.