Trial Outcomes & Findings for Botulinum Toxin is a Potential Prophylactic Therapy for Minimizing Post-excisional Scarring (Allergan Botox Scar Study) (NCT NCT02623829)
NCT ID: NCT02623829
Last Updated: 2020-12-08
Results Overview
MMSS scores range 5-18, higher score indicates poorer health outcomes. The MMSS assesses color, texture, distortion and contour of the scar.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
6 months
Results posted on
2020-12-08
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin
subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
|
Saline
subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Botulinum Toxin
subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
|
Saline
subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Botulinum Toxin is a Potential Prophylactic Therapy for Minimizing Post-excisional Scarring (Allergan Botox Scar Study)
Baseline characteristics by cohort
| Measure |
Botulinum Toxin
n=20 Participants
subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
|
Saline
n=20 Participants
subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
59 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Smoking history
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Autoimmune conditions
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Scar location
Median forehead
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Scar location
Paramedian forehead
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Scar location
Lateral forehead
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Scar length
|
58 mm
n=5 Participants
|
54 mm
n=7 Participants
|
55 mm
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsMMSS scores range 5-18, higher score indicates poorer health outcomes. The MMSS assesses color, texture, distortion and contour of the scar.
Outcome measures
| Measure |
Botulinum Toxin
n=20 Participants
subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
|
Saline
n=20 Participants
subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
|
|---|---|---|
|
Modified Manchester Scar Scale (MMSS) Score
|
8 score on a scale
Interval 6.0 to 11.0
|
11.5 score on a scale
Interval 9.0 to 14.0
|
SECONDARY outcome
Timeframe: 6 monthsVisual Analog Scar Scale (VASS), full score range 0-10 higher score indicates poorer health outcomes
Outcome measures
| Measure |
Botulinum Toxin
n=20 Participants
subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
|
Saline
n=20 Participants
subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
|
|---|---|---|
|
Visual Analog Scar Scale
|
2 score on a scale
Interval 1.0 to 3.0
|
3.5 score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 6 monthsScar width at 6 months after treatment
Outcome measures
| Measure |
Botulinum Toxin
n=20 Participants
subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
|
Saline
n=20 Participants
subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
|
|---|---|---|
|
Scar Width
|
2.2 mm
Interval 1.8 to 3.0
|
3.2 mm
Interval 2.8 to 3.6
|
Adverse Events
Botulinum Toxin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Botulinum Toxin
n=20 participants at risk
subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
|
Saline
n=20 participants at risk
subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
|
|---|---|---|
|
Eye disorders
mild unilateral eyelid ptosis
|
5.0%
1/20 • 6 months
|
0.00%
0/20 • 6 months
|
Additional Information
Dr. Daniel Bernstein
Icahn School of Medicine at Mount Sinai
Phone: 212-731-3311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place