Phase 2
N=30
Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair
Cleft Lip · Scarring · Cleft Palate
Bottom Line
View on ClinicalTrials.gov: NCT02247193 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons — 7; 9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Botulinum Toxin Type A (Drug); Normal Saline Injection (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons |
7; 9 | — |
| PRIMARY Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons |
7; 9 | — |
| PRIMARY Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Blinded Plastic Surgeons |
6; 7 | — |
| PRIMARY Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Blinded Plastic Surgeons |
6; 7 | — |
| PRIMARY Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Crowdsourced Raters |
7.48; 7.72 | — |
| PRIMARY Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Crowdsourced Raters |
7.48; 7.72 | — |
| PRIMARY Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Crowdsourced Raters |
6.01; 6.19 | — |
| PRIMARY Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Crowdsourced Raters |
6.01; 6.19 | — |
Summary
Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar
Eligibility Criteria
Inclusion Criteria
- complete unilateral cleft lip with or without cleft palate
- planned for a primary cleft lip repair
Exclusion Criteria
-bilateral cleft lip
Data sourced from ClinicalTrials.gov (NCT02247193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.