Acne Scars, Stretch Marks, and Similar Skin Defects Qualify as Medical Problems. A Real-World Survey on a Hyaluronic Acid Medical Device

Abstract

Introduction: Beyond impacting the quality of life, unpleasant stretch marks, skin aging, the dermal scars secondary to acne and chickenpox, and wrinkles expose those harboring these skin defects to psychiatric problems like anxiety, depression, ADHD, and insomnia more often than one might suspect. Remodeling skin scarring and supporting the deteriorated networks of dermal elastic fibers also have medical value. The moisturizing properties and skin-protective scavenger action against free radicals rapidly developed by non-cross-linked hyaluronic acid offer a powerful rationale to help with those problems. Methods: The study focused on a survey questionnaire administered by the investigators to a prospective cohort of 45 subjects of both genders with stretch marks, dermal scars, and skin aging. Before the survey, all individuals had undergone a three-session treatment cycle with a Class-III CE-marked medical device containing 40 mg of non-cross-linked HA in 2-mL prefilled disposable syringes with 30G½ needles (IALEST®, Mastelli Srl, Sanremo, Italy). The primary observational efficacy assessment tool was the six-score Wrinkle Severity Rating Scale (WSRS); the secondary efficacy assessment tool was the five-score Global Aesthetic Improvement Scale (GAIS). Timing of WSRS and GAIS assessments: at baseline (T0), before the first intradermal treatment session, and three to four weeks after T2 (end of the treatment cycle). Results: The mean WSRS scores for skin quality significantly improved between the T0 baseline visit (2.8 ± 1.17) and the T2 final follow-up visit (1.6 ± 1.09; –42.9%, p <0.001). The cohort distribution of the GAIS skin quality descriptors assessed by the investigators improved by one severity level in 66.7% of surveyed subjects, two severity levels in 20.0%, and four levels in 2.2%. Only a tiny cohort minority (2 individuals out of 45, 4.4%) reported no subjective improvement in skin quality. Among surveyed participants, 95.6% reported a clinically meaningful skin quality improvement. The device safety was high. Conclusions: The real-world survey, performed within the framework of a long-term program to monitor the device’s clinical performance and safety over time, demonstrated that the HA-based medical device retains its long-standing record of efficient performance and excellent safety with no variations over time.