Microneedle patch based on dissolving, detachable microneedle technology for improved skin quality of the periorbital region. Part 2: Clinical Evaluation.

OBJECTIVE Microneedle patches based on dissolving, detachable micro-needle technology (Russian patent No. 2652567; US patent EFS No. 32735812; WO/2019/231360) are novel dermatological products that allow safe, painless and effective reduction of epidermal wrinkles after 6 procedures. The purpose of this study was two-fold a) to assess the safety and efficacy of micro-needle patches comprising 650 micro-needles containing hyaluronic and ferulic acids after 6 procedures of applying the applicator to the skin for 25 minutes; and b) to correlate our previously reported ex-vivo findings. METHODS The micro-needle applicator contains 650 micro-needles, which dissolve in 25 minutes of exposure. The effectiveness of micro-needle applicators was confirmed by a randomized split-phase study involving 82 subjects. Applications of micro-needle patches were performed at intervals of 2 times per week, and the effectiveness was assessed at 6 weeks after the start of the study. RESULTS The results of the profilometric evaluation of skin smoothness demonstrated a significant reduction in the average roughness index by 65.32±2.99% and in the mean skin waviness by 66.84±1.6% compared to these indicators in the control group (p<0.05). The therapeutic effect of the procedure was confirmed by an ultrasound examination that registered a 72.2±5.4% and 25±1.4% increase in echo-density of the epidermis and dermis, respectively. An independent blinded skin evaluation by dermatologists revealed steady decrease in puffiness of the application area in 89.9% of patients, increased elasticity in 78.3% of the patients, and reduced severity of epidermal wrinkles in 89.9% of the patients. CONCLUSIONS The applicator with 650 soluble micro-needles on its surface containing hyaluronic and ferulic acids is considered a safe, effective and convenient way to improve the skin quality in the periorbital region after 6 procedures. Nevertheless, additional studies of soluble micro-needles are required to fully assess the amount and distribution area of the injected hyaluronic acid and other active components, as well as to detail the mechanism of action of soluble micro-needles to improve skin quality.