NCT01004042

Quality of Life and Self-esteem After Botox® Injections in Depressed and Non-depressed Patients

Evaluation of Quality of Life and Self-esteem After Botulinum Toxin type-a (Botox®) Injections in Depressed and Non-depressed Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hexsel Dermatology Clinic · Academic / Other
• Sex: Female
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Depression
• Quality of Life

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A	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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2009-10-29
• Last updated: 2021-01-26
• Results posted: 2021-01-26

Locations

1 site across 1 country: Brazil