MedTrace Logo

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

NCT01004042 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-26

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Brazilan Center for Studies in Dermatology

    lead OTHER

Principal Investigators

  • Doris M Hexsel, MD · Brazilian Center For Studies in Dermatology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01004042 on ClinicalTrials.gov