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Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment for Moderate to Severe Glabellar Lines.

Abstract

BACKGROUND

The aesthetic use of botulinum toxins is widely accepted in routine treatment of glabellar lines.

OBJECTIVE

To strengthen existing efficacy and safety data, and examine subject satisfaction concerning abobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines.

MATERIALS AND METHODS

A 150-day prospective, single-dose, multicenter, randomized, parallel-group, placebo-controlled, double-blind study of 300 subjects treated with ABO (50 Units [U]). Response was defined as having no or mild glabellar lines after treatment (primary objective was Day 30 response). Glabellar line severity, onset and duration of effect, satisfaction, treatment emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs) were assessed.

RESULTS

Median time to onset of effect was 2 days. Day 30, ABO treatment response was 89% and 85% for investigator and subject assessments, respectively (p < .001 vs placebo). At Day 120, 60% of subjects demonstrated ≥1 grade improvement and 45% at Day 150. Subject satisfaction concerning glabellar line appearance was high (93%) at Day 14 and maintained by 35% through Day 150 with ABO treatment. No serious AEs were related to study treatment.

CONCLUSION

Most ABO-treated subjects sustained ≥1 grade glabellar line improvements over 120 days, and satisfaction was maintained by >30% of subjects throughout 150 days. ABO was well tolerated.

Authors+Show Affiliations

Departments of Dermatology and Ophthalmology, University of Alabama at Birmingham, Birmingham, Alabama.Baumann Cosmetic and Research Institute and Division of Cosmetic Dermatology, University of Miami, Miami, Florida.Mass Clinic, San Francisco, California.Rhonda Rand MD Inc., Beverly Hills, California.Zenith Healthcare Communications Ltd., Chester, Cheshire, United Kingdom.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31356432

Citation

Monheit, Gary D., et al. "Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment for Moderate to Severe Glabellar Lines." Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [et Al.], 2019.
Monheit GD, Baumann L, Maas C, et al. Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment for Moderate to Severe Glabellar Lines. Dermatol Surg. 2019.
Monheit, G. D., Baumann, L., Maas, C., Rand, R., & Down, R. (2019). Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment for Moderate to Severe Glabellar Lines. Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [et Al.], doi:10.1097/DSS.0000000000002013.
Monheit GD, et al. Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment for Moderate to Severe Glabellar Lines. Dermatol Surg. 2019 Jul 23; PubMed PMID: 31356432.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment for Moderate to Severe Glabellar Lines. AU - Monheit,Gary D, AU - Baumann,Leslie, AU - Maas,Corey, AU - Rand,Rhonda, AU - Down,Rebecca, Y1 - 2019/07/23/ PY - 2019/7/30/entrez PY - 2019/7/30/pubmed PY - 2019/7/30/medline JF - Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] JO - Dermatol Surg N2 - BACKGROUND: The aesthetic use of botulinum toxins is widely accepted in routine treatment of glabellar lines. OBJECTIVE: To strengthen existing efficacy and safety data, and examine subject satisfaction concerning abobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines. MATERIALS AND METHODS: A 150-day prospective, single-dose, multicenter, randomized, parallel-group, placebo-controlled, double-blind study of 300 subjects treated with ABO (50 Units [U]). Response was defined as having no or mild glabellar lines after treatment (primary objective was Day 30 response). Glabellar line severity, onset and duration of effect, satisfaction, treatment emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs) were assessed. RESULTS: Median time to onset of effect was 2 days. Day 30, ABO treatment response was 89% and 85% for investigator and subject assessments, respectively (p < .001 vs placebo). At Day 120, 60% of subjects demonstrated ≥1 grade improvement and 45% at Day 150. Subject satisfaction concerning glabellar line appearance was high (93%) at Day 14 and maintained by 35% through Day 150 with ABO treatment. No serious AEs were related to study treatment. CONCLUSION: Most ABO-treated subjects sustained ≥1 grade glabellar line improvements over 120 days, and satisfaction was maintained by >30% of subjects throughout 150 days. ABO was well tolerated. SN - 1524-4725 UR - https://www.unboundmedicine.com/medline/citation/31356432/Efficacy,_Safety,_and_Subject_Satisfaction_After_AbobotulinumtoxinA_Treatment_for_Moderate_to_Severe_Glabellar_Lines L2 - http://dx.doi.org/10.1097/DSS.0000000000002013 DB - PRIME DP - Unbound Medicine ER -