A multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of 3 doses of botulinum toxin A in the treatment of glabellar lines
| Autor: | Benjamin Zakine, Ali Bougara, Philippe Kestemont, Benjamin Ascher, José Santini, Martine Baspeyras |
|---|---|
| Rok vydání: | 2004 |
| Předmět: |
Adult
Male medicine.medical_specialty Placebo-controlled study Facial Muscles Dermatology Placebo complex mixtures Drug Administration Schedule law.invention Patient satisfaction Double-Blind Method Randomized controlled trial law Photography Humans Medicine Forehead Botulinum Toxins Type A Adverse effect Aged Intention-to-treat analysis business.industry Middle Aged Skin Aging Surgery Clinical trial Treatment Outcome medicine.anatomical_structure Patient Satisfaction Female business |
| Zdroj: | Journal of the American Academy of Dermatology. 51:223-233 |
| ISSN: | 0190-9622 |
| DOI: | 10.1016/j.jaad.2003.11.084 |
| Popis: | Botulinum toxin A (BTX-A) is used to treat glabellar lines but the rigorous demonstration of its efficacy in a well-designed study had never been reported.This study was designed to evaluate the efficacy and the safety of 3 doses of BTX-A in the treatment of glabellar lines.A total of 119 patients with moderate to severe glabellar lines at rest were treated with 25, 50, or 75 U of BTX-A (Dysport, Ipsen) or placebo divided into 5 intramuscular glabellar sites. Outcome measures included evaluations of glabellar lines by independent experts from blinded standardized photographs at rest 1 month after treatment, physician evaluations, and patient assessments during a 6-month period.A significant efficacy was reported for the 3 BTX-A groups for at least 3 months after injection (at least P.015). Investigator and patient evaluations suggested that 50 U was the optimal dose. BTX-A was well tolerated. No blepharoptosis was reported. An evaluation in blinded conditions by independent experts was necessary because the results were overestimated by the investigators.BTX-A is an effective and safe treatment for glabellar lines. |
| Databáze: | OpenAIRE |
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