BACKGROUND:Injectable hyaluronic acid is frequently used to correct volume loss in nasolabial folds. OBJECTIVE: To compare the safety and efficacy of a novel hyaluronic acid gel to a non-animal stabilized hyaluronic acid (Comparator) gel for the correction of nasolabial folds (NLF). METHODS: Qualified subjects had NLF with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe). NLFs were treated with Test Product on one side of the face and Comparator on the other side of the face (facial side randomly assigned). Improvement from baseline was evaluated at weeks 1, 2, 4, 12, and 24 weeks. The primary study endpoint was the mean change in WSRS score from baseline to week 24. RESULTS: The mean changes in WSRS score from baseline were 1.02 ±0.689 for Test Product and 0.91±0.762 for Comparator. The mean difference in change from baseline in WSRS scoring (Comparator minus Test Product) at week 24 was -0.11 (-0.225-0.001, 95% confidence interval [CI]). The upper boundary (0.001) of the 95% CI was less than the prespecified non-inferiority limit of 0.50, indicating that the Test Product was non-inferior to the Comparator. No subject discontinued the study due to adverse events. CONCLUSION: The Test Product is safe and non-inferior to the Comparator for the correction of nasolabial folds. The Test Product was associated with less swelling, pain, and overall severity of treatment-emergent adverse events than the Comparator. <p><em>J Drugs Dermatol. 2018;17(1):66-73.</em></p>.
RCT Entities:
BACKGROUND: Injectable hyaluronic acid is frequently used to correct volume loss in nasolabial folds. OBJECTIVE: To compare the safety and efficacy of a novel hyaluronic acid gel to a non-animal stabilized hyaluronic acid (Comparator) gel for the correction of nasolabial folds (NLF). METHODS: Qualified subjects had NLF with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe). NLFs were treated with Test Product on one side of the face and Comparator on the other side of the face (facial side randomly assigned). Improvement from baseline was evaluated at weeks 1, 2, 4, 12, and 24 weeks. The primary study endpoint was the mean change in WSRS score from baseline to week 24. RESULTS: The mean changes in WSRS score from baseline were 1.02 ±0.689 for Test Product and 0.91±0.762 for Comparator. The mean difference in change from baseline in WSRS scoring (Comparator minus Test Product) at week 24 was -0.11 (-0.225-0.001, 95% confidence interval [CI]). The upper boundary (0.001) of the 95% CI was less than the prespecified non-inferiority limit of 0.50, indicating that the Test Product was non-inferior to the Comparator. No subject discontinued the study due to adverse events. CONCLUSION: The Test Product is safe and non-inferior to the Comparator for the correction of nasolabial folds. The Test Product was associated with less swelling, pain, and overall severity of treatment-emergent adverse events than the Comparator. <p><em>J Drugs Dermatol. 2018;17(1):66-73.</em></p>.
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