Trial Outcomes & Findings for Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face (NCT NCT00986570)
NCT ID: NCT00986570
Last Updated: 2015-12-11
Results Overview
Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.
COMPLETED
PHASE3
121 participants
Baseline (pre-treatment) and Visit 3 (Day 15)
2015-12-11
Participant Flow
Date of recruitment : 01-Sep-2009 to 09-Feb-2010 Location: Outpatient clinic; Cosmiatry, surgery and oncology unit, Department of Dermatology, UNIFESP, Sao Paulo, Brazil
Participant milestones
| Measure |
Xeomin®
Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)
|
|---|---|
|
Overall Study
STARTED
|
121
|
|
Overall Study
COMPLETED
|
114
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Xeomin®
Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Potential bias for objective assessment
|
1
|
Baseline Characteristics
Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face
Baseline characteristics by cohort
| Measure |
Xeomin®
n=121 Participants
Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)
|
|---|---|
|
Age, Customized
Between 30 and 50 years
|
121 participants
n=5 Participants
|
|
Age, Continuous
|
42.52 years
STANDARD_DEVIATION 0.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
121 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment) and Visit 3 (Day 15)Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.
Outcome measures
| Measure |
Xeomin®
n=121 Participants
Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)
|
|---|---|
|
Treatment Success
|
89.08 % of participants
Interval 83.48 to 94.68
|
Adverse Events
Xeomin®
Serious adverse events
| Measure |
Xeomin®
n=121 participants at risk
Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)
|
|---|---|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.83%
1/121 • Number of events 1
|
Other adverse events
| Measure |
Xeomin®
n=121 participants at risk
Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Eyelid edema
|
1.7%
2/121 • Number of events 2
|
|
Surgical and medical procedures
Injection-site bleeding
|
32.2%
39/121 • Number of events 41
|
|
Surgical and medical procedures
Injection-site pain
|
7.4%
9/121 • Number of events 9
|
|
Surgical and medical procedures
Injection-site pruritus
|
3.3%
4/121 • Number of events 4
|
|
Surgical and medical procedures
Deformity
|
5.0%
6/121 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Worsening of baseline wrinkles
|
1.7%
2/121 • Number of events 2
|
|
Surgical and medical procedures
Site-injection edema
|
0.83%
1/121 • Number of events 1
|
|
Nervous system disorders
Headache
|
20.7%
25/121 • Number of events 25
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/121 • Number of events 2
|
|
Infections and infestations
Sore throat
|
0.83%
1/121 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.83%
1/121 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.83%
1/121 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.83%
1/121 • Number of events 1
|
Additional Information
Priscilla Padilha, MD
Biolab Sanus Farmacêutica Ltda.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place