CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Botulinum Toxin Type Adrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01004042
NCT01004042Phase 4Completed
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Evaluation of Quality of Life and Self-esteem After Botulinum Toxin type-a (Botox®) Injections in Depressed and Non-depressed Patients

Hexsel Dermatology Clinic·interventional·Posted Oct 29, 2009·Updated Jan 26, 2021

In Brief

A Phase 4 clinical trial evaluating Botulinum Toxin Type A for Depression and Quality of Life. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Quality of Life
CountriesBrazil
CollaboratorsAllergan

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2009
Enrollment StartOct 1, 2009
Primary CompletionMar 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.7 years ago

Interventions

Botulinum Toxin Type Adrug

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.