Tags

Type your tag names separated by a space and hit enter

A double-blind, randomized, placebo-controlled, two-dose comparative study of botulinum toxin type A for treating glabellar lines in Japanese subjects.
Aesthetic Plast Surg. 2008 Sep; 32(5):724-30.AP

Abstract

BACKGROUND

Systematic, well-controlled clinical trials of botulinum toxin type A (BoNTA) in diverse patient populations are needed. The aim of this study was to characterize the safety and efficacy of 10-U and 20-U BoNTA doses versus placebo for treating glabellar lines in Japanese subjects.

METHODS

A 16-week, multicenter, double-blind, randomized, placebo-controlled trial comparing 10 or 20 U of BoNTA versus placebo in 142 Japanese subjects with glabellar lines of at least moderate severity at maximal contraction. The primary efficacy endpoint was physician-rated line severity at maximal contraction 4 weeks after treatment. Secondary efficacy endpoints included physician/subject ratings and estimates of the effect's duration.

RESULTS

Response rates by physician-rated line severity at maximal contraction (week 4) were 86.4% (10 U), 88.6% (20 U), and 0% (placebo, p < 0.001). Line severity at maximal contraction in each BoNTA group (p < 0.001) improved significantly from baseline at each visit. BoNTA and placebo differed significantly on all other efficacy measures. Mean duration of effect was 9.4 weeks in the 20-U group and 7.9 weeks in the 10-U BoNTA group. No serious adverse events occurred.

CONCLUSION

Doses of BoNTA of 10 and 20 U are effective and safe for treating glabellar lines in Japanese subjects, and the 20-U dose provides greater efficacy and longer duration of effect.

Authors+Show Affiliations

Department of Plastic and Reconstructive Surgery, School of Medicine, Kyorin University, Mitaka-shi, Tokyo, Japan. harii@kyorin-u.ac.jpNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18663516

Citation

Harii, Kiyonori, and Makoto Kawashima. "A Double-blind, Randomized, Placebo-controlled, Two-dose Comparative Study of Botulinum Toxin Type a for Treating Glabellar Lines in Japanese Subjects." Aesthetic Plastic Surgery, vol. 32, no. 5, 2008, pp. 724-30.
Harii K, Kawashima M. A double-blind, randomized, placebo-controlled, two-dose comparative study of botulinum toxin type A for treating glabellar lines in Japanese subjects. Aesthetic Plast Surg. 2008;32(5):724-30.
Harii, K., & Kawashima, M. (2008). A double-blind, randomized, placebo-controlled, two-dose comparative study of botulinum toxin type A for treating glabellar lines in Japanese subjects. Aesthetic Plastic Surgery, 32(5), 724-30. https://doi.org/10.1007/s00266-008-9199-6
Harii K, Kawashima M. A Double-blind, Randomized, Placebo-controlled, Two-dose Comparative Study of Botulinum Toxin Type a for Treating Glabellar Lines in Japanese Subjects. Aesthetic Plast Surg. 2008;32(5):724-30. PubMed PMID: 18663516.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, randomized, placebo-controlled, two-dose comparative study of botulinum toxin type A for treating glabellar lines in Japanese subjects. AU - Harii,Kiyonori, AU - Kawashima,Makoto, Y1 - 2008/07/29/ PY - 2008/03/14/received PY - 2008/05/30/accepted PY - 2008/7/30/pubmed PY - 2009/1/17/medline PY - 2008/7/30/entrez SP - 724 EP - 30 JF - Aesthetic plastic surgery JO - Aesthetic Plast Surg VL - 32 IS - 5 N2 - BACKGROUND: Systematic, well-controlled clinical trials of botulinum toxin type A (BoNTA) in diverse patient populations are needed. The aim of this study was to characterize the safety and efficacy of 10-U and 20-U BoNTA doses versus placebo for treating glabellar lines in Japanese subjects. METHODS: A 16-week, multicenter, double-blind, randomized, placebo-controlled trial comparing 10 or 20 U of BoNTA versus placebo in 142 Japanese subjects with glabellar lines of at least moderate severity at maximal contraction. The primary efficacy endpoint was physician-rated line severity at maximal contraction 4 weeks after treatment. Secondary efficacy endpoints included physician/subject ratings and estimates of the effect's duration. RESULTS: Response rates by physician-rated line severity at maximal contraction (week 4) were 86.4% (10 U), 88.6% (20 U), and 0% (placebo, p < 0.001). Line severity at maximal contraction in each BoNTA group (p < 0.001) improved significantly from baseline at each visit. BoNTA and placebo differed significantly on all other efficacy measures. Mean duration of effect was 9.4 weeks in the 20-U group and 7.9 weeks in the 10-U BoNTA group. No serious adverse events occurred. CONCLUSION: Doses of BoNTA of 10 and 20 U are effective and safe for treating glabellar lines in Japanese subjects, and the 20-U dose provides greater efficacy and longer duration of effect. SN - 1432-5241 UR - https://www.unboundmedicine.com/medline/citation/18663516/A_double_blind_randomized_placebo_controlled_two_dose_comparative_study_of_botulinum_toxin_type_A_for_treating_glabellar_lines_in_Japanese_subjects_ L2 - https://dx.doi.org/10.1007/s00266-008-9199-6 DB - PRIME DP - Unbound Medicine ER -