Clinical Assessment of 2 Licensed AbobotulinumtoxinA Injection Volumes for the Treatment of Glabellar Lines

• Published in: Dermatologic surgery Vol. 45; no. 10; pp. 1274 - 1284
• Main Authors: Kaufman, Joely, Cohen, Joel L, Peredo, Marina I, Jonas, Brandie, Down, Rebecca, Nogueira, Alessandra
• Format: Journal Article
• Language: English
• Published: United States by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved 01-10-2019
• Subjects: Acetylcholine Release Inhibitors - administration & dosage; Acetylcholine Release Inhibitors - adverse effects; Adolescent; Adult; Botulinum Toxins, Type A - administration & dosage; Botulinum Toxins, Type A - adverse effects; Cosmetic Techniques - adverse effects; Dose-Response Relationship, Drug; Facial Muscles - drug effects; Female; Forehead; Headache - chemically induced; Headache - epidemiology; Humans; Injection Site Reaction - epidemiology; Injections, Subcutaneous; Male; Middle Aged; Patient Satisfaction; Prospective Studies; Skin Aging - drug effects; Time Factors; Treatment Outcome; Young Adult
• ISSN: 1076-0512; 1524-4725
• DOI: 10.1097/DSS.0000000000001926

BACKGROUNDTwo licensed reconstitution volumes may be used to achieve the recommended abobotulinumtoxinA (ABO) dose for glabellar line correction.
OBJECTIVEComparison of efficacy, safety, and subject satisfaction concerning treatment of moderate to severe glabellar lines with 2 different ABO reconstitution volumes.
MATERIALS AND METHODSPhase IV, prospective, randomized, multicenter, subject- and evaluator-blinded study60 subjects received 1 ABO (50 units) treatment, administered as a 1.5- or 2.5-mL reconstitution. Primary objective was Day 30 improvements (≥1-point) in glabellar line severity. Onset of effect, duration, subject satisfaction, and treatment-related adverse events (AEs) were assessed.
RESULTSAt Day 30, 90.0% and 86.7% of subjects achieved ≥1-point improvements with 1.5- and 2.5-mL reconstitutions, respectively. Median time to onset of effect was 48 hours after treatment. At 24 hours, 26.7% achieved ≥1-point improvements with the 2.5-mL reconstitution versus 6.7% with the 1.5-mL reconstitution. Maximum response was at Day 14, and >40% maintained efficacy through Day 120 in each group. High subject satisfaction was sustained throughout observation. Most AEs were mild. No serious AEs were reported.
CONCLUSIONBoth ABO reconstitutions were well tolerated and effective in correcting glabellar lines with no significant differences concerning efficacy or duration of effect. No serious AEs were reported.