IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines
| Autor: | Martina Kerscher, Michael H. Gold, Corey S. Maas, Steve Yoelin, Susanna Roll, John H Joseph, Tanja C. Fischer, Berthold Rzany, Welf Prager, Sabrina G. Fabi, Gudrun Klein |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Time Factors Esthetics Facial Muscles Cosmetic Techniques Toxicology Injections Intramuscular Botulinum toxin a law.invention Young Adult 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Humans Medicine Prospective Studies Forehead Botulinum Toxins Type A Young adult Duration of effect Prospective cohort study Adverse effect Aged Facial wrinkle scale Dose-Response Relationship Drug business.industry Incidence (epidemiology) General Medicine Middle Aged Dose-ranging study Skin Aging Clinical trial Safety profile Dose–response relationship Treatment Outcome Neuromuscular Agents 030220 oncology & carcinogenesis Anesthesia Female business |
| Zdroj: | Journal of Drugs in Dermatology. 19:985-991 |
| ISSN: | 1545-9616 |
| DOI: | 10.36849/jdd.2020.5454 |
| Popis: | Background To further explore clinical trial results indicating increasing doses of botulinum toxin A prolong duration of effect, a 2-stage, phase 2, randomized, double-blind study investigated the duration of effect and safety of incobotulinumtoxinA (INCO; Xeominr, Bocouturer) doses higher than the US Food and Drug Administration-approved 20 units (U) for glabellar frown lines (GFL). The stage 1 primary efficacy and safety results were reported previously. Here, we report the results of the final analysis (stage 1 and 2), including primary and secondary efficacy and safety endpoints. Methods A total of 241 subjects with moderate-to-severe GFL were randomized to receive a single treatment with 20 (N=61), 50 (N=60), 75 (N=61), or 100U (N=59) INCO. The primary efficacy endpoint was duration of g 1-point improvement from baseline assessed by investigator at maximum frown on the Facial Wrinkle Scale. Results The median duration of effect was 175 days for the 20U group (95% CI 142, 185), 185 days for the 50U group (95% CI 182, 205), 210 days for the 75U group (95% CI 182, 217), and 215 days for the 100U group (95% CI 183, 237). The incidence of treatment-related adverse events was low across all doses and there were no treatment-related serious adverse events. Conclusions These results demonstrate that all INCO doses were well tolerated, consistent with the known safety profile of 20U, and increasing dose prolongs the duration of effect for GFL. J Drugs Dermatol. 2021;20(10):1052-1060. doi:10.36849/JDD.6377THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS. |
| Databáze: | OpenAIRE |
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