Full-Face Injections of Variable Total Doses of Abobotulinum Toxin Type A: A Randomized, Phase IV Clinical Trial of Safety and Efficacy
December 2013 | Volume 12 | Issue 12 | Original Article | 1356 | Copyright © 2013
Doris Hexsel MD,a,b Cristiano Brum MD Ms,a,c Manoela D. Porto MD,a Mariana Soirefmann MD Ms,a,b Carolina Siega BSc,a Juliana Schilling-Souza BPharm,a and Ticiana C. Rodrigues MD PhDa,d
aBrazilian Center for Studies in Dermatology, Porto Alegre, Brazil
bCosmetic Dermatology, Department of Dermatology, Pontificia Universidade Catolica do Rio Grande do Sul, Porto Alegre, Brazil
cComplexo Hospitalar Santa Casa, Porto Alegre, Brazil
dDepartment of Internal Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
BACKGROUND: Botulinum toxin type A (BoNT-A) has been used for almost 20 years in cosmetic dermatology to reduce dynamic wrinkles
on single or multiple facial areas.
OBJECTIVE: To evaluate the safety and efficacy of full-face treatments with various total doses of abobotulinum toxin A (ABO).
METHODS: A total of 90 participants were enrolled. Subjects had at least two indications for BoNT-A treatments on each third of the face (upper, middle and lower). They were randomized into 3 groups, with pre-defined total dose range of ABO, varying from 120 to 250 U.
RESULTS: Most of the subjects were women (96.5%). The statistically significant improvement from baseline lasted for more than 24 weeks for glabellar lines, and more than 16 weeks for forehead wrinkles and crow's feet, all P<0.001, with no differences between groups. The most frequent adverse event (excessive perioral weakness) was related to high dose in the perioral area.
CONCLUSIONS: This is the first study to compare safety and efficacy of different doses of ABO administered to the entire face simultaneously. As long as the recommended doses are used, concomitant injections of ABO are safe and efficient, with no increase in adverse events.
J Drugs Dermatol. 2013;12(12):1356-1362.
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Botulinum toxin type A (BoNT-A) has been used for almost 20 years in cosmetic dermatology to reduce various facial dynamic wrinkles and for other cosmetic indications.1 The clinical benefits occur within 1 week after the injections, with an average duration of 4-5 months.2,3 Cosmetic treatment with BoNTA has been used in single or multiple facial areas, according to patient needs.4-6 Several articles have shown efficacy of BoNT-A injections in specific areas of the upper face3,7-11 as well as middle and lower face.12-16 When multiple indications for BoNT-A are present, the full-face approach is recommended. A single touch up can be done after the treatment, usually 15 to 30 days later.17
Although this full-face approach has been used frequently on dermatologic practice, there is no available data on the literature about the efficacy and safety when multiple indications in more than two thirds of the face are treated in a single session with BoNT-A. Moreover, no studies have evaluated the optimal total and consensus doses of BoNT-A in the full-face approach.
This study evaluated the safety and efficacy of full-face treatments with three different total doses of abobotulinum toxin A (ABO) (Dysport®, Ipsen Biopharm Ltd., Wrexham, UK).
MATERIAL AND METHODS
Study Design and Subjects
This was a prospective, single-center, randomized, open-label study of full-face injections of three different doses of ABO. It was conducted at the Brazilian Center for Studies in Dermatology, in Porto Alegre, Brazil, and was approved by the ethics committee of Hospital Moinhos de Vento (ClinicalTrials.gov Identifier: NCT01032954). All subjects were fully informed about the study in accordance with the applicable regulations and GCP/ICH guidelines and provided written informed consent prior to the study. The main inclusion criterion was the presence of at least two indications for BoNT-A treatment on each third of the face (upper, middle and lower). Eligible subjects were 30 to 60 years old, naïve to BoNT-A or had not received BoNT-A treatment in the previous six months, and agreed not to undergo other cosmetic or dermatologic procedures during the study. The main exclusion criteria were pregnancy, presence of scars or other dermatological conditions that could interfere with the evaluation of the results, and muscular or neurological diseases.
The randomization list was generated by a statistician and subjects were sequentially allocated into 3 groups in a 1:1:1 proportion, with pre-defined total dose ranges of ABO: group