Trial Outcomes & Findings for Quality of Life and Self-esteem After Botox® Injections in Depressed and Non-depressed Patients (NCT NCT01004042)
NCT ID: NCT01004042
Last Updated: 2021-01-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
Depressed Subjects
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.
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.
|
Non Depressed Subjects
Subjects with no diagnosis of depression
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quality of Life and Self-esteem After Botox® Injections in Depressed and Non-depressed Patients
Baseline characteristics by cohort
| Measure |
Depressed Subjects
n=25 Participants
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.
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.
|
Non Depressed Subjects
n=25 Participants
Subjects with no diagnosis of depression
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 7 • n=5 Participants
|
48 years
STANDARD_DEVIATION 7 • n=7 Participants
|
49 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Fitzpatrick Skin Phototype I · Phototype I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Fitzpatrick Skin Phototype I · Phototype II
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Fitzpatrick Skin Phototype I · Phototype III
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Fitzpatrick Skin Phototype I · Phototype IV
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Fitzpatrick Skin Phototype I · Phototype V
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Fitzpatrick Skin Phototype I · Phototype VI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Marital status
Married or steady relationship
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Marital status
Single
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital status
Divorced
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Education
College
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Education
College (not completed)
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
High School
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Education
Middle School
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12Population: per protocol.
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.
Outcome measures
| Measure |
Depressed Subjects
n=21 Participants
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.
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.
|
Non Depressed Subjects
n=25 Participants
Subjects with no diagnosis of depression
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.
|
|---|---|---|
|
Rosenberg Self-Esteem Scale
Baseline
|
13.9 units on a scale
Standard Deviation 5.3
|
24.6 units on a scale
Standard Deviation 4.3
|
|
Rosenberg Self-Esteem Scale
Day 1 (intervention)
|
13.5 units on a scale
Standard Deviation 5.0
|
23.3 units on a scale
Standard Deviation 5.3
|
|
Rosenberg Self-Esteem Scale
Week 4
|
15.2 units on a scale
Standard Deviation 5.8
|
23.5 units on a scale
Standard Deviation 4.9
|
|
Rosenberg Self-Esteem Scale
Week 8
|
17.1 units on a scale
Standard Deviation 5.9
|
24.4 units on a scale
Standard Deviation 4.6
|
|
Rosenberg Self-Esteem Scale
Week 12
|
16.9 units on a scale
Standard Deviation 6.5
|
24.2 units on a scale
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12Population: Per protocol.
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.
Outcome measures
| Measure |
Depressed Subjects
n=21 Participants
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.
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.
|
Non Depressed Subjects
n=25 Participants
Subjects with no diagnosis of depression
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.
|
|---|---|---|
|
Beck Depression Inventory (BDI)
Baseline
|
27.4 units on a scale
Standard Deviation 5.2
|
6.7 units on a scale
Standard Deviation 5.5
|
|
Beck Depression Inventory (BDI)
Day 1 (intervention)
|
24.3 units on a scale
Standard Deviation 8.8
|
5.8 units on a scale
Standard Deviation 4.5
|
|
Beck Depression Inventory (BDI)
Week 4
|
17.0 units on a scale
Standard Deviation 7.9
|
5.3 units on a scale
Standard Deviation 4.1
|
|
Beck Depression Inventory (BDI)
Week 8
|
14.9 units on a scale
Standard Deviation 9.9
|
4.5 units on a scale
Standard Deviation 4.4
|
|
Beck Depression Inventory (BDI)
Week 12
|
12.5 units on a scale
Standard Deviation 7.9
|
4.0 units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12Population: Per protocol.
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.
Outcome measures
| Measure |
Depressed Subjects
n=21 Participants
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.
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.
|
Non Depressed Subjects
n=25 Participants
Subjects with no diagnosis of depression
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.
|
|---|---|---|
|
WHOQOL-BREF
Day 1 (intervention)
|
2.9 units on a scale
Standard Deviation 0.85
|
4.0 units on a scale
Standard Deviation 0.81
|
|
WHOQOL-BREF
Baseline
|
2.9 units on a scale
Standard Deviation 0.77
|
3.9 units on a scale
Standard Deviation 0.49
|
|
WHOQOL-BREF
Week 4
|
3.6 units on a scale
Standard Deviation 0.60
|
4.1 units on a scale
Standard Deviation 0.53
|
|
WHOQOL-BREF
Week 8
|
3.5 units on a scale
Standard Deviation 0.89
|
4.1 units on a scale
Standard Deviation 0.57
|
|
WHOQOL-BREF
Week 12
|
3.4 units on a scale
Standard Deviation 0.81
|
4.1 units on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Population: Per protocol
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
Outcome measures
| Measure |
Depressed Subjects
n=21 Participants
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.
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.
|
Non Depressed Subjects
n=25 Participants
Subjects with no diagnosis of depression
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.
|
|---|---|---|
|
Wrinkle Severity Scale (WSS) at Rest
Baseline
|
1.6 units on a scale
Standard Deviation 0.76
|
1.5 units on a scale
Standard Deviation 0.51
|
|
Wrinkle Severity Scale (WSS) at Rest
Week 4
|
0.4 units on a scale
Standard Deviation 0.61
|
0.5 units on a scale
Standard Deviation 0.59
|
|
Wrinkle Severity Scale (WSS) at Rest
Week 8
|
0.4 units on a scale
Standard Deviation 0.62
|
0.4 units on a scale
Standard Deviation 0.58
|
|
Wrinkle Severity Scale (WSS) at Rest
Week 12
|
0.4 units on a scale
Standard Deviation 0.62
|
0.7 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12Population: Per protocol.
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
Outcome measures
| Measure |
Depressed Subjects
n=21 Participants
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.
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.
|
Non Depressed Subjects
n=25 Participants
Subjects with no diagnosis of depression
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.
|
|---|---|---|
|
Wrinkle Severity Scale (WSS) at Maximum Contraction
Baseline
|
2.6 units on a scale
Standard Deviation 0.69
|
2.7 units on a scale
Standard Deviation 0.48
|
|
Wrinkle Severity Scale (WSS) at Maximum Contraction
Week 4
|
1.1 units on a scale
Standard Deviation 0.64
|
1.2 units on a scale
Standard Deviation 0.65
|
|
Wrinkle Severity Scale (WSS) at Maximum Contraction
Week 8
|
0.9 units on a scale
Standard Deviation 0.80
|
1.2 units on a scale
Standard Deviation 0.80
|
|
Wrinkle Severity Scale (WSS) at Maximum Contraction
Week 12
|
1.4 units on a scale
Standard Deviation 0.70
|
1.7 units on a scale
Standard Deviation 0.56
|
Adverse Events
Non Depressed Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Depressed Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non Depressed Subjects
n=25 participants at risk
Subjects with no diagnosis of depression
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.
|
Depressed Subjects
n=25 participants at risk
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.
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Edema
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Mild eyebrow ptosis
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
Additional Information
Dr. Doris Hexsel
Brazilian Center for Studies in Dermatology
Phone: +55 51 30262633
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place