DepressionPhase 4NCT01004042

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

A Phase 4 study testing Botulinum Toxin Type A in people with Depression and Quality of Life, run by Hexsel Dermatology Clinic at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 25 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Depression, Quality of Life
What is being tested?: Botulinum Toxin Type A
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteBrazil
Study dates: Oct 2009to Apr 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female subjects,aged between 25 to 60 years;
Subjects diagnosed as having major depression according to the criteria of DSM-IV, MINI International Neuropsychiatric Interview (MINI Brazilian version 5.0.0);
Subjects who are being administered a therapeutic dose of an approved, prescribed antidepressant medication (pattern doses of the literature), and have been using mentioned medication at a stable therapeutic dose for at least three months prior to the randomization visit;
Subjects with mild (1), moderate (2) or severe (3) glabellar frown lines while at rest according the Severity Wrinkles Scales;
Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method;
Subjects who had never received botulinum toxin A previously;

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Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form;
Subjects who will be available throughout the duration of the study;
Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol;
Subjects with Critical appreciation preserved, attested by their assistant psychiatrist (for group1);
Subjects who reside with other family members who assume co-responsibility in the study.

Who cannot join

Subjects whose medical history and physical examination present clinical pathology, as myasthenia gravis, Eaton-Lambert Syndrome, neoplasm, muscular diseases, motor neuron diseases, systemic autoimmune or neurological diseases;
Pregnant or women in breastfeeding, or women planning to become pregnant
Subjects with suicide risk;
Subjects addicted to alcohol or illegal drugs within the last 6 months;
Subjects using amino glycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers;
Subjects using medications that, in the opinion of the investigator may cause depression, such as beta-blockers, oral corticosteroids and interferon;

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Subjects who, in the opinion of the investigator, may potentially require psychiatric hospitalization during the course of the study;
Subjects with inflammation or active infection in the area to be injected;
Subjects with a history of non-adherence to medical treatment, or who demonstrate unwillingness to adhere to the study protocol;
The presence of any additional active DSM-IV Axis I diagnosis, or mental retardation;
History of psychiatric hospitalization within the past three years.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, 90570 040

Other trials in Brazil

About this study

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

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.

Read the 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
Being tested: Botulinum Toxin Type A
Keywords: Depression, Botulinum toxin, Glabella, Quality of life, Self-steem
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botulinum Toxin Type ADrug
Also called Botox®
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.

Study groups in NCT01004042
Study group	Role	What they receive
Depressed subjects	Active comparator	Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist. Receives: Drug: Botulinum Toxin Type A
Non Depressed subjects	Active comparator	Subjects with no diagnosis of depression Receives: Drug: Botulinum Toxin Type A

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

Secondary outcomes (3)

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.
Measured: 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
Measured: 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
Measured: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Apr 2010

First posted29 Oct 2009 (estimated)
Study startOct 2009
Primary completionMar 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01004042
Sponsor's protocol ID: 09-CBED09-02
Status last verified: Jan 2021
First submitted: 28 Oct 2009
Last updated: 26 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Quality of Life and Self-esteem After Botulinum Toxin type-a (Botox®) Injections in Depressed and Non-depressed Patients
ClinicalTrials.gov ID: NCT01004042
Acronym / sponsor ID: 09-CBED09-02
Conditions: Depression, Quality of Life
Keywords: Depression, Botulinum toxin, Glabella, Quality of life, Self-steem
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Hexsel Dermatology ClinicUniversity, hospital or other
Collaborators: Allergan
Study start: Oct 2009
Primary completion: Mar 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 29 Oct 2009 (estimated)
Results: Posted 26 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Depressed subjects	Active comparator	Drug: Botulinum Toxin Type ADiagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.
Non Depressed subjects	Active comparator	Drug: Botulinum Toxin Type ASubjects with no diagnosis of depression

Who may qualify

Ages: 25 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Female subjects,aged between 25 to 60 years;
Subjects diagnosed as having major depression according to the criteria of DSM-IV, MINI International Neuropsychiatric Interview (MINI Brazilian version 5.0.0);
Subjects who are being administered a therapeutic dose of an approved, prescribed antidepressant medication (pattern doses of the literature), and have been using mentioned medication at a stable therapeutic dose for at least three months prior to the randomization visit;
Subjects with mild (1), moderate (2) or severe (3) glabellar frown lines while at rest according the Severity Wrinkles Scales;
Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method;

Key exclusion criteria (11 listed)

Subjects whose medical history and physical examination present clinical pathology, as myasthenia gravis, Eaton-Lambert Syndrome, neoplasm, muscular diseases, motor neuron diseases, systemic autoimmune or neurological diseases;
Pregnant or women in breastfeeding, or women planning to become pregnant
Subjects with suicide risk;
Subjects addicted to alcohol or illegal drugs within the last 6 months;
Subjects using amino glycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Botulinum Toxin Type AAlso: Botox®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.	Drug	Depressed subjects, Non Depressed subjects

Primary outcome

Rosenberg Self-Esteem Scale
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
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.
Beck Depression Inventory (BDI)
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
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.

3 secondary outcomes

WHOQOL-BREF
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Wrinkle Severity Scale (WSS) at Rest
Time frame: Baseline, Week 4, Week 8, Week 12
Wrinkle Severity Scale (WSS) at Maximum Contraction
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

Results and safety

Results posted to the registry on 26 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Depressed Subjects	25	21
Non Depressed Subjects	25	25

Primary outcome: Rosenberg Self-Esteem Scale

Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Depressed Subjects n = 21	Non Depressed Subjects n = 25
Baseline	13.9 (5.3)	24.6 (4.3)
Day 1 (intervention)	13.5 (5.0)	23.3 (5.3)
Week 4	15.2 (5.8)	23.5 (4.9)
Week 8	17.1 (5.9)	24.4 (4.6)
Week 12	16.9 (6.5)	24.2 (4.9)

Population analysed: per protocol.

Primary outcome: Beck Depression Inventory (BDI)

Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Depressed Subjects n = 21	Non Depressed Subjects n = 25
Baseline	27.4 (5.2)	6.7 (5.5)
Day 1 (intervention)	24.3 (8.8)	5.8 (4.5)
Week 4	17.0 (7.9)	5.3 (4.1)
Week 8	14.9 (9.9)	4.5 (4.4)
Week 12	12.5 (7.9)	4.0 (3.4)

Population analysed: Per protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Depressed Subjects	0 of 25 (0%)	1 of 25 (4%)	Not reported
Non Depressed Subjects	0 of 25 (0%)	1 of 25 (4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Doris M Hexsel, MD principal investigator

Brazilian Center For Studies in Dermatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Botulinum Toxin Type A in people with Depression and Quality of Life, run by Hexsel Dermatology Clinic at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rosenberg Self-Esteem Scale (time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01004042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.