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Phase IV study comparing incobotulinumtoxinA and onabotulinumtoxinA using a 1:1.5 dose-conversion ratio for the treatment of glabellar frown lines.
J Cosmet Dermatol 2012; 11(4):267-71JC

Abstract

BACKGROUND

IncobotulinumtoxinA and onabotulinumtoxinA are effective treatments for glabellar frown lines, and a dose of 20 U is recommended for both preparations. However, debate continues over using the same dosages of these products, although a 1:1 dose ratio has been proven in several head-to-head clinical trials in neurological and esthetic indications.

OBJECTIVES

To investigate whether a 50% higher dose of onabotulinumtoxinA was nonsuperior to incobotulinumtoxinA in the treatment of glabellar frown lines in the short and long term.

METHODS AND MATERIALS

Subjects aged 18-65 years with symmetrical moderate-to-severe glabellar frown lines (score: ≥2 on a validated Merz 5-point scale) at maximum frown were enrolled. Corrugator muscles on both sides were treated with two injections of either 4 U incobotulinumtoxinA or 6 U onabotulinumtoxinA (equivalent to 20 and 30 U, respectively, if corrugator muscles on both sides and the procerus are treated) allowing intra-individual comparison. Glabellar frown line severity was assessed from standardized photographs every 4 weeks for 4 months and, in a subset of subjects, for up to 6 months posttreatment. The primary efficacy endpoint was the percentage of subjects with an improvement of ≥1 point on the 5-point scale at week 4. Nonsuperiority was assessed by comparing the response rates of each product.

RESULTS

Nonsuperiority of a 50% higher dose of onabotulinumtoxinA to that of incobotulinumtoxinA was confirmed at 4 weeks, 4 months, and 6 months posttreatment.

CONCLUSION

There is generally no reason to increase the dose of either incobotulinumtoxinA or onabotulinumtoxinA above the 20 U recommended for glabellar frown lines.

Authors+Show Affiliations

Dermatologikum, Hamburg, Germany. prager@dermatologikum.deNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Controlled Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23174049

Citation

Prager, Welf, and Thomas Rappl. "Phase IV Study Comparing incobotulinumtoxinA and onabotulinumtoxinA Using a 1:1.5 Dose-conversion Ratio for the Treatment of Glabellar Frown Lines." Journal of Cosmetic Dermatology, vol. 11, no. 4, 2012, pp. 267-71.
Prager W, Rappl T. Phase IV study comparing incobotulinumtoxinA and onabotulinumtoxinA using a 1:1.5 dose-conversion ratio for the treatment of glabellar frown lines. J Cosmet Dermatol. 2012;11(4):267-71.
Prager, W., & Rappl, T. (2012). Phase IV study comparing incobotulinumtoxinA and onabotulinumtoxinA using a 1:1.5 dose-conversion ratio for the treatment of glabellar frown lines. Journal of Cosmetic Dermatology, 11(4), pp. 267-71. doi:10.1111/jocd.12001.
Prager W, Rappl T. Phase IV Study Comparing incobotulinumtoxinA and onabotulinumtoxinA Using a 1:1.5 Dose-conversion Ratio for the Treatment of Glabellar Frown Lines. J Cosmet Dermatol. 2012;11(4):267-71. PubMed PMID: 23174049.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase IV study comparing incobotulinumtoxinA and onabotulinumtoxinA using a 1:1.5 dose-conversion ratio for the treatment of glabellar frown lines. AU - Prager,Welf, AU - Rappl,Thomas, Y1 - 2012/10/02/ PY - 2012/07/04/accepted PY - 2012/11/24/entrez PY - 2012/11/24/pubmed PY - 2013/5/29/medline SP - 267 EP - 71 JF - Journal of cosmetic dermatology JO - J Cosmet Dermatol VL - 11 IS - 4 N2 - BACKGROUND: IncobotulinumtoxinA and onabotulinumtoxinA are effective treatments for glabellar frown lines, and a dose of 20 U is recommended for both preparations. However, debate continues over using the same dosages of these products, although a 1:1 dose ratio has been proven in several head-to-head clinical trials in neurological and esthetic indications. OBJECTIVES: To investigate whether a 50% higher dose of onabotulinumtoxinA was nonsuperior to incobotulinumtoxinA in the treatment of glabellar frown lines in the short and long term. METHODS AND MATERIALS: Subjects aged 18-65 years with symmetrical moderate-to-severe glabellar frown lines (score: ≥2 on a validated Merz 5-point scale) at maximum frown were enrolled. Corrugator muscles on both sides were treated with two injections of either 4 U incobotulinumtoxinA or 6 U onabotulinumtoxinA (equivalent to 20 and 30 U, respectively, if corrugator muscles on both sides and the procerus are treated) allowing intra-individual comparison. Glabellar frown line severity was assessed from standardized photographs every 4 weeks for 4 months and, in a subset of subjects, for up to 6 months posttreatment. The primary efficacy endpoint was the percentage of subjects with an improvement of ≥1 point on the 5-point scale at week 4. Nonsuperiority was assessed by comparing the response rates of each product. RESULTS: Nonsuperiority of a 50% higher dose of onabotulinumtoxinA to that of incobotulinumtoxinA was confirmed at 4 weeks, 4 months, and 6 months posttreatment. CONCLUSION: There is generally no reason to increase the dose of either incobotulinumtoxinA or onabotulinumtoxinA above the 20 U recommended for glabellar frown lines. SN - 1473-2165 UR - https://www.unboundmedicine.com/medline/citation/23174049/Phase_IV_study_comparing_incobotulinumtoxinA_and_onabotulinumtoxinA_using_a_1:1_5_dose_conversion_ratio_for_the_treatment_of_glabellar_frown_lines_ L2 - https://doi.org/10.1111/jocd.12001 DB - PRIME DP - Unbound Medicine ER -