Trial Outcomes & Findings for Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair (NCT NCT02247193)
NCT ID: NCT02247193
Last Updated: 2021-11-03
Results Overview
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
COMPLETED
PHASE1/PHASE2
30 participants
6 months
2021-11-03
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
Number Who Underwent Cleft Lip Repair Surgery
|
15
|
15
|
|
Overall Study
Number Who Received Botox or Placebo
|
15
|
15
|
|
Overall Study
Number Who Completed the 6-month Follow up
|
15
|
15
|
|
Overall Study
Number Who Completed the 12-month Follow up
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair
Baseline characteristics by cohort
| Measure |
Botulinum Toxin
n=15 Participants
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
n=15 Participants
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
129.53 days
STANDARD_DEVIATION 27.27 • n=93 Participants
|
135.67 days
STANDARD_DEVIATION 17.41 • n=4 Participants
|
132.6 days
STANDARD_DEVIATION 22.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Number of Participants with Syndromic Cleft Lip
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Number of Participants with Presurgical Nasoalveolar Molding (PNAM)
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Number of Participants with Complete Cleft Lip
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Number of Participants with Unilateral Cleft Lip
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Number of Participants with Cleft Palate
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure.
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
Outcome measures
| Measure |
Botulinum Toxin
n=9 Participants
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
n=11 Participants
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
|---|---|---|
|
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons
|
7 score on a scale
Interval 7.0 to 10.0
|
9 score on a scale
Interval 8.0 to 10.0
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure.
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
Outcome measures
| Measure |
Botulinum Toxin
n=9 Participants
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
n=11 Participants
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
|---|---|---|
|
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons
|
7 score on a scale
Interval 6.5 to 7.0
|
9 score on a scale
Interval 6.5 to 9.5
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure.
The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
Outcome measures
| Measure |
Botulinum Toxin
n=9 Participants
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
n=11 Participants
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
|---|---|---|
|
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Blinded Plastic Surgeons
|
7 score on a scale
Interval 6.0 to 8.0
|
8 score on a scale
Interval 6.0 to 8.0
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure.
The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
Outcome measures
| Measure |
Botulinum Toxin
n=9 Participants
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
n=11 Participants
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
|---|---|---|
|
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Blinded Plastic Surgeons
|
6 score on a scale
Interval 6.0 to 7.0
|
7 score on a scale
Interval 6.5 to 7.5
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure.
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.
Outcome measures
| Measure |
Botulinum Toxin
n=9 Participants
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
n=11 Participants
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
|---|---|---|
|
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Crowdsourced Raters
|
7.40 score on a scale
Standard Deviation 0.74
|
8.29 score on a scale
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Only 8 in the Botulinum Toxin arm and 12 in the Saline arm were analyzed for this outcome measure.
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.
Outcome measures
| Measure |
Botulinum Toxin
n=8 Participants
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
n=12 Participants
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
|---|---|---|
|
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Crowdsourced Raters
|
7.48 score on a scale
Standard Deviation 0.78
|
7.72 score on a scale
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure.
The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.
Outcome measures
| Measure |
Botulinum Toxin
n=9 Participants
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
n=11 Participants
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
|---|---|---|
|
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Crowdsourced Raters
|
5.96 score on a scale
Standard Deviation 0.74
|
6.74 score on a scale
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Only 8 in the Botulinum Toxin arm and 12 in the Saline arm were analyzed for this outcome measure.
The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.
Outcome measures
| Measure |
Botulinum Toxin
n=8 Participants
Injection of botulinum toxin into cleft lip at time of surgical repair.
Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
Saline
n=12 Participants
Injection of normal saline into cleft lip at time of surgical repair.
Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
|
|---|---|---|
|
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Crowdsourced Raters
|
6.01 score on a scale
Standard Deviation 0.75
|
6.19 score on a scale
Standard Deviation 0.69
|
Adverse Events
Botulinum Toxin
Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Matthew R. Greives, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place