ABSTRACT
OBJECTIVE: Hyaluronic acid has been used for a long time as a biorevitalizer to treat skin aging both in single formulation and in association with other compounds such as amino acids or vitamins. The purpose of this study was to evaluate the efficacy and safety of class III medical devices SKIN B, SKIN R, SKIN OX, SKIN COLIN, for the treatment of wrinkles on the face, neck, décolleté and hands. These medical devices are all based on hyaluronic acid and supplemented with amino acids (SKIN B and SKIN R) and glutathione (SKIN OX) or colin (SKIN COLIN). This gives broader possibilities to the aesthetic surgeon for personalization and pharmacological diversification based on the patient's deficits to treat. PATIENTS AND METHODS: A total of 60 subjects affected by skin damage such as rhytidids, dehydration, reduced sebum production and skin hypoxia were enrolled. The patients were treated with a session of mesotherapy every 7 days for 30 days, followed by other 2 sessions every 15 days for 30 days and the follow-up on day 90. The primary efficacy endpoint was evaluated by means of a 0-10 visual analog scale at day 60; the secondary efficacy endpoint was evaluated by means of a 0-10 visual analog scale at day 90. RESULTS: All patients completed the 3-month follow-up. Treatment with SKIN B, SKIN OX, SKIN COLIN and SKIN R medical devices for the prevention and treatment of wrinkles on the face, neck, décolleté and hands were associated with favorable and positive results. A clear reduction of wrinkles has been clinically observed with improvement in the texture, brightness, and turgor of the skin. No adverse events were reported. CONCLUSIONS: The medical devices SKIN B, SKIN SKIN OX, SKIN COLIN produce an aesthetic improvement in patients affected by skin defects, when administered by mesotherapy technique. This study confirms the safety and efficacy of the medical devices based on hyaluronic acid supplemented with amino acids and glutathione or colin.
