Won Joon Choi1, Seung Won Han1, Jung Eun Kim1, Hye Won Kim2, Moon Beom Kim3, Hoon Kang4. 1. Department of Dermatology, St. Paul Hospital, College of Medicine, The Catholic University of Korea, 180 Wangsan-ro Dongdaemun-gu, 130-709, Seoul, Korea. 2. Department of Dermatology, Gangnam Sacred Heart Hospital, College of Medicine, Hallym University of Korea, Seoul, Korea. 3. Department of Dermatology, Pusan National University Hospital, College of Medicine, Pusan National University, Pusan, Korea. 4. Department of Dermatology, St. Paul Hospital, College of Medicine, The Catholic University of Korea, 180 Wangsan-ro Dongdaemun-gu, 130-709, Seoul, Korea. johnkang@catholic.ac.kr.
Abstract
BACKGROUND: The use of injectable hyaluronic acid-based gel is well established in aesthetic facial procedures especially on the nasolabial fold (NLF). OBJECTIVE: To compare the efficacy and safety of PP-501-A-Lidocaine dermal filler with RestylaneLidocaine(®) when administered to the NLF. METHODS:Sixty-six subjects seeking correction of NLFs, with moderate or severe wrinkle severity, were recruited for this multicenter, randomized, patient and evaluator-blind, matched pairs, and active-controlled design clinical study. PP-501-A-Lidocaine and RestylaneLidocaine(®) were injected into the deep layer of the dermis and/or subcutis of the NLF. The first validity evaluation variable was the average wrinkle severity rating scale (WSRS), as scored by independent blinded evaluators at week 24. The second validity evaluation variable including the global aesthetic improvement scale (GAIS), the WSRS, and adverse event reporting at weeks 8, 16, and 24 were also performed. RESULTS: The mean improvement in the WSRS from baseline was 1.58 ± 0.68 for the PP-501-A-Lidocaine and 1.51 ± 0.66 for the RestylaneLidocaine(®) at week 24. The average value at week 8 after the final application was 1.62 ± 0.78 and 1.60 ± 0.75 in parts subject to PP-501-A-Lidocaine and RestylaneLidocaine(®), respectively, and 1.58 ± 0.70 and 1.57 ± 0.68 at week 16, respectively. Both improvement and duration of the treatment effect were similar between the two groups. GAIS data rated by the treating investigator and participants showed no statistically significant differences. Both fillers were well tolerated and adverse reactions were mild and transient in most cases. CONCLUSION:PP-501-A-Lidocaine showed an equivalent efficacy and safety observed after 6 months of follow-up compared to RestylaneLidocaine(®). LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266.
RCT Entities:
BACKGROUND: The use of injectable hyaluronic acid-based gel is well established in aesthetic facial procedures especially on the nasolabial fold (NLF). OBJECTIVE: To compare the efficacy and safety of PP-501-A-Lidocaine dermal filler with RestylaneLidocaine(®) when administered to the NLF. METHODS: Sixty-six subjects seeking correction of NLFs, with moderate or severe wrinkle severity, were recruited for this multicenter, randomized, patient and evaluator-blind, matched pairs, and active-controlled design clinical study. PP-501-A-Lidocaine and RestylaneLidocaine(®) were injected into the deep layer of the dermis and/or subcutis of the NLF. The first validity evaluation variable was the average wrinkle severity rating scale (WSRS), as scored by independent blinded evaluators at week 24. The second validity evaluation variable including the global aesthetic improvement scale (GAIS), the WSRS, and adverse event reporting at weeks 8, 16, and 24 were also performed. RESULTS: The mean improvement in the WSRS from baseline was 1.58 ± 0.68 for the PP-501-A-Lidocaine and 1.51 ± 0.66 for the RestylaneLidocaine(®) at week 24. The average value at week 8 after the final application was 1.62 ± 0.78 and 1.60 ± 0.75 in parts subject to PP-501-A-Lidocaine and RestylaneLidocaine(®), respectively, and 1.58 ± 0.70 and 1.57 ± 0.68 at week 16, respectively. Both improvement and duration of the treatment effect were similar between the two groups. GAIS data rated by the treating investigator and participants showed no statistically significant differences. Both fillers were well tolerated and adverse reactions were mild and transient in most cases. CONCLUSION:PP-501-A-Lidocaine showed an equivalent efficacy and safety observed after 6 months of follow-up compared to RestylaneLidocaine(®). LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266.
Authors: Tomasz Stefura; Artur Kacprzyk; Jakub Droś; Marta Krzysztofik; Oksana Skomarovska; Marta Fijałkowska; Mateusz Koziej Journal: Aesthetic Plast Surg Date: 2021-07-13 Impact factor: 2.708