Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair
Purpose
Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar
Conditions
- Cleft Lip
- Scarring
- Cleft Palate
Eligibility
- Eligible Ages
- Under 6 Months
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- complete unilateral cleft lip with or without cleft palate - planned for a primary cleft lip repair
Exclusion Criteria
- bilateral cleft lip
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Botulinum Toxin |
Injection of botulinum toxin into cleft lip at time of surgical repair. |
|
Placebo Comparator Saline |
Injection of normal saline into cleft lip at time of surgical repair. |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center, Houston