INTRODUCTION: This study describes a pivotal clinical trial of a new minimally invasive cosmetic procedure for facial rejuvenation and for the treatment of scars and wrinkles. METHODS: The procedure consisted of a combination of techniques such as fillers, biorevitalization, peeling, and intradermal radiofrequency, emitted from a new device denominated by Spherofill Medical Plus (SMP; Spherofill MD, PromoItalia Group S.p.A., Pozzuoli, Italy), for treating cutaneous regeneration, depressions, and striae. One hundred and twelve patients, divided into five groups, were treated. RESULTS: The results produced were statistically analyzed and resulted in significant and long-lasting effects for facial rejuvenation. Indeed, the analysis of the Global Aesthetic Improvement Scale (GAIS) scores in the five groups demonstrated statistically significant results between 3 and 9 months after the treatments. CONCLUSION: Evaluating the patients included in the study, it is possible to conclude that the treatment with SMP represents a safe and efficient solution for the treatment of wrinkles, acne lesions, striae, and of degenerated tissues caused by aging.
INTRODUCTION: This study describes a pivotal clinical trial of a new minimally invasive cosmetic procedure for facial rejuvenation and for the treatment of scars and wrinkles. METHODS: The procedure consisted of a combination of techniques such as fillers, biorevitalization, peeling, and intradermal radiofrequency, emitted from a new device denominated by Spherofill Medical Plus (SMP; Spherofill MD, PromoItalia Group S.p.A., Pozzuoli, Italy), for treating cutaneous regeneration, depressions, and striae. One hundred and twelve patients, divided into five groups, were treated. RESULTS: The results produced were statistically analyzed and resulted in significant and long-lasting effects for facial rejuvenation. Indeed, the analysis of the Global Aesthetic Improvement Scale (GAIS) scores in the five groups demonstrated statistically significant results between 3 and 9 months after the treatments. CONCLUSION: Evaluating the patients included in the study, it is possible to conclude that the treatment with SMP represents a safe and efficient solution for the treatment of wrinkles, acne lesions, striae, and of degenerated tissues caused by aging.