Trials / Completed
CompletedNCT02247193
Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Accepted
Summary
Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| DRUG | 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. |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2020-01-13
- Completion
- 2020-01-13
- First posted
- 2014-09-23
- Last updated
- 2021-11-03
- Results posted
- 2021-11-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02247193. Inclusion in this directory is not an endorsement.