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The primary objective of this study is to determine the alterations in quality of life and self-steem after BOTOX® injections in the glabella in depressed and non-depressed patients.
The secondary objective of this study are:
- to elaborate a description of the muscles involved in the Veraguth Fold
- to evaluate depressive symptoms using Beck Depression Inventory before and after Botox® injections.
- to elucidate that depression is not a contraindication for botulinum toxin injections.
The study consists of two groups: one with diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0) and other without diagnosis of depression.
Subjects with depression will be part of group 1. They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.
Subjects with no diagnosis of depression will be part of group 2. Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.
Four visits will be scheduled. Visit 0 (baseline), Visit 1 (intervention), visit 2 (4 weeks), visit 3 (8 weeks) visit 4 (12 weeks).
The scales for the assessment of depressive symptoms, Beck Depression Inventory (BDI), will be applied at visits 1,2,3,4; WHOQOL BREF will be applied at baseline visit and 4.
Rosenberg Self-Esteem Scale will be applied in all visits. Photographs will be taken as well as the dermatological evaluation of the wrinkles and folds will be assessed using a 4-points validated Severity Wrinkles Scale, and psychiatric evaluation as well, in both groups.
Allocation: Non-Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Botulinum Toxin Type A - BOTOX
Brazilian Center for Studies in Dermatology
Rio Grande do Sul
Brazilan Center for Studies in Dermatology
Published on BioPortfolio: 2014-08-27T03:18:21-0400
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