The primary objective of this study is to determine the alterations in quality of life and self-esteem after BOTOX® injections in the glabella in depressed and non-depressed patients. The secondary objective of this study are: * to assess wrinkles improvement * 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, Brazil
Rosenberg Self-Esteem Scale
Measure of self esteem for research purposes. Ten questions graded from 0 to 3 as described below: Questions 1, 3, 4, 7, 10 0 - Totally agree 1. \- Agree 2. \- Disagree 3. \- Totally disagree Questions 2, 5, 6, 8, 9 3 - Totally agree 2 - Agree 1 - Disagree 0 - Totally disagree The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Beck Depression Inventory (BDI)
BDI is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Each question is graded from 0 to 3. 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
WHOQOL-BREF
The WHOQOL-BREF is a scale for the quality of life assessment developed by the World Health Organization. It is composed by 26 questions graded from 1 to 5. Scoring: 1 to 2.9 - needs improvement 3 to 3.9 - regular 4 to 4.9 - good 5 - very good Question 1 asks about the individual's overall perception of quality of life. Results refer to question 1.
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Wrinkle Severity Scale (WSS) at Rest
The injection of botulinum toxin type A causes muscle paralysis, reducing facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The WSS is a 4-point validated scale for forehead lines: 0 - None 1. \- Mild 2. \- Moderate 3. \- Severe
Time frame: Baseline, Week 4, Week 8, Week 12
Wrinkle Severity Scale (WSS) at Maximum Contraction
The injection of botulinum toxin type A causes muscle paralysis, reducing facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The WSS is a 4-point validated scale for forehead lines: 0 - None 1. \- Mild 2. \- Moderate 3. \- Severe
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Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12