Quality of Life and Satisfaction of Patients After Full-Face Injections of Abobotulinum Toxin Type A: A Randomized, Phase IV Clinical Trial
December 2013 | Volume 12 | Issue 12 | Original Article | 1363 | 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: Although botulinum toxin type A (BoNT-A) has been used effectively and safely to reduce facial dynamic wrinkles, few
studies assessed patients' quality of life and satisfaction after treatment.
OBJECTIVE: To assess the quality of life and satisfaction of patients treated with full-face injections of variable doses of abobotulinum toxin A (ABO).
METHODS: Ninety subjects were randomized into 3 different groups, receiving 120-165 U, 166-205 U and 206-250 U, respectively. WHOQOL- BREF and Satisfaction and Self-assessment Questionnaire (SSQ) were completed by subjects up to 6 months after treatment.
RESULTS: Most of the subjects were women (96.5%). For the physical domain in WHOQOL, a difference was observed between baseline and visit 2 (p = 0.036). There was no difference between groups for mean grades regarding amount of wrinkles, beauty, harmony and symmetry. However, there was a significant difference in the mean grades between visits. Patients' opinions also showed an improvement in their self-image up to four months after treatment, according to the self-grading.
CONCLUSION: The results presented in this study show improvements in patients' quality of life during the peak of action of BoNT-A treatment, regarding the physical aspect. In addition, patients reported good satisfaction after a full-face approach.
J Drugs Dermatol. 2013;12(12):1363-1367.
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The clinical benefits of botulinum toxin type A (BoNT-A) in cosmetic dermatology occur very quickly, and can be seen approximately 2 to 4 days1 after the injections, with an average duration of 4 to 5 months.2,3 Several articles have shown safety and efficacy of BoNT-A injections in the upper face4-9 as well as the lower face10-13, reinforcing the use of a full-face procedure. Although patient satisfaction has been evaluated in some studies of BoNT-A, with wrinkle improvements and high levels of satisfaction12,14- 20 no trials have studied the influence of BoNT-A injections on the quality of life, assessed by the WHOQOL questionnaire. One study has correlated the use of BoNT-A with a more positive mood21 and more recently, BoNT-A was associated with improvement on depression score of depressed patients.22 Therefore, this study aimed to assess the quality of life and satisfaction of patients treated with full-face injections (upper, mid and lower face) of variable doses of abobotulinum toxin type A (ABO) (Dysport®, Ipsen Biopharm Ltd., Wrentham, UK) based on the recommendations of the International Board on Botulinum Toxin Azzalure (IBBA).23,24
MATERIAL AND METHODS
Study Design and Subjects
This was a prospective, single-center, randomized, and open-label study of full-face injections of variable doses of BoNT-A.23,24
It 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 treatments on each third of the face (upper, middle and lower). Eligible subjects were 30 to 60 years old, naïve to BoNT-A treatment or had not received BoNT-A 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 (1:1:1) with a specific dose range of ABO for the full-face treatment: group 1 - 120 to 165 U; group 2 - 166 to 205 U; and group 3 - 206 to 250 U.
There were a total of 7 visits in the study: baseline, injection, and weeks 4, 5, 16, 20, and 24 after the injections. Demographic