A New Minimally Invasive Mesotherapy Technique for Facial Rejuvenation

Antonella Savoia 0 1 Simone Landi 0 1 Alfonso Baldi 0 1 0 A. Baldi (&) Department of Biochemistry, Sect. Pathology, Second University of Naples , Via L. Armanni 5, 80138 Naples, Italy 1 A. Savoia S. Landi Promoitalia Group S.p.A, Pozzuoli, Naples, Italy Introduction: This study describes a pivotal clinical trial of a new minimally invasive mesotherapy technique for facial rejuvenation. Methods: The authors utilized two formulations: formulation A with hyaluronic acid, vitamins, amino acids, minerals, coenzymes, and antioxidant substances; formulation B with hyaluronic acid and idebenone. Fifty participants were enrolled in the study and divided in two groups. Group 1 (50-65 years) treated with formulation A. Group 2 (35-50 years) treated with formulation B. The groups underwent four sessions of mesotherapy involving multiple injections. Treatment was conducted at 15 day intervals. All participants had pre- and posttreatment photographs. Punch biopsies were taken from randomly selected participants, baseline and after 6 weeks, and stained for interleukin (IL)-6, IL1b, matrix metalloproteinase (MMP)-1, and collagen 1. Clinical evaluation was based on the Global Aesthetic Scale (GAIS) and on the Wrinkle Severity Rating Scale (WSRS). Results: The results produced were statistically analyzed and resulted in a significant and long-lasting effect on facial rejuvenation. Evaluation of photographs at 0, 1, and 2 months revealed significant clinical improvement: brightness, texture, and firmness of the skin. The analysis of the GAIS and WSRS scores in the two groups demonstrated statistically significant results after 2 months. The biopsies taken from randomly selected participants at baseline and after 3 months showed a decrease in IL1b, IL-6, and MMP1, and an increase in collagen 1. Conclusion: The new minimally invasive mesotherapy technique described can improve the clinical appearance of the skin in different age groups. - INTRODUCTION Aging is an increasing concern of modern society, particularly aging of the face. This is a complex process involving two important factors: volume loss throughout the face, and repetitive muscle movements that cause wrinkles and folds [1]. Traditionally, facial rejuvenation has focused on various dermatologic cosmetic procedures such as carbon dioxide laser resurfacing, microdermabrasion, and electric stimulation leading to collagen production in human skin fibroblasts [2, 3]. In recent years there has been an increasing emphasis on mesotherapy as an anti-aging strategy. Mesotherapy is a medical procedure introduced by Pistor in 1958, which consists of intradermal injection of pharmacologic substances, such as nutrients, hormones, vitamins, enzymes, and other reagents that have been diluted and are administered directly into the region to be treated [4]. The aim of mesotherapy in skin rejuvenation is maintenance and/or restoration of healthy and youthful texture of the skin [5, 6]. The desired final effect is firm, bright, moisturized skin obtained by the injection in the superficial dermis of suitable products that are perfectly biocompatible and totally absorbable [7]. In fact, injection of mesotherapy products promotes skin rejuvenation by increasing both hydration and fibroblast activation [8, 9]. Several experimental studies have demonstrated that hyaluronic acid injected into the skin can stimulate fibroblasts to express collagen type 1 (Col-1), matrix metalloprotease-1 (MMP-1), and tissue inhibitor of matrix metalloproteinase-1 (TIMP) [10]. Another study suggested that dermal injection of vitamins results in stimulation of collagen production in skin cells [11]. It is also well known that antioxidant substances are able to reverse aging. One the most studied hypotheses regarding aging is that it is caused by oxidative stress, and oxidation can damage proteins, DNA, and lipids. The present study describes a pivotal comparative clinical study of a minimally invasive technique of skin rejuvenation consisting of multiple intradermal injections with two formulations with the goal of maintenance and/or restoration of healthy and youthful skin texture. MATERIALS AND METHODS In this clinical study two different formulations were used: formulation A, which was composed of hyaluronic acid, vitamins, amino acids, minerals, coenzymes, and antioxidants (Table 1), and formulation B, which was composed of hyaluronic acid, idebenone, polysorbate 20, water, acetyl cysteine, sodium chloride. Fifty healthy patients of both genders were enrolled in the study and were divided into two groups: group 1 (32 patients), aged between 50 and 60 years (older patients) and group 2 (18 patients), aged between 35 and 50 years (younger patients). Formulation A was used for patients in group 1 and formulation B was used for patients in group 2. Exclusion criteria for the study were: patients that had undergone other medical-aesthetical treatments, and pregnant or breastfeeding women. Inclusion criteria were: Table 1 Characteristics of formulation A Amino acids Nucleotides Coenzymes Sodium chloride Adenine Sodium hyaluronate Acetyl cysteine Polysorbate 20 Pyridoxine HCL Thiamine HCL Ascorbic acid Calcium pantothenate Phenylalanine Histidine hydrochloride Glutamic acid Aspartic acid HCL hydrochloride patients in good health, patients that were not using any other treatments, and patients that presented mild/moderate to severe photo-aging. The patients did not modify their lifestyle. All patients gave written consent for enrollment into the clinical study, and ethical approval was obtained for the study. Treatment and Evaluation Protocol Each treatment was carried out according to a default protocol, which was similar for the two groups. Briefly, all participants underwent four sessions of mesotherapy involving multiple injections with a 30 G/4 mm needle in the face, neck, and decollete. The hands of eight patients were additionally treated. Treatments were conducted over 2 months. The objective examination was carried out with inspection using a Woods light (GIMA S.p.A., Gessate, Milano, Italy) and palpation to verify cutaneous elasticity. The areas of the body treated were examined by the sense of touch and pressure. The results were defined with a score derived from the Global Aesthetic Improvement Scale (GAIS), used as a reference parameter (Table 2); a summary of the patients characteristics and of GAIS scores obtained is provided in Table 3. The photographic evaluation was performed at the beginning and at the end of the treatment. 1 Exceptional 2 Very improved patient 3 Improved patient Table 2 Global aesthetic improvement scale Excellent corrective result after a session with the Spherofill device Marked improvment of the appearance, but not completely optimal. A touch-up would slightly improve the result Improvement of the appearance, better compared to the initial condition, but a touch-up is advised 4 Unaltered patient The appearance substanti (...truncated)