Houston, Texas 77030


Objectives: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the scar Study Design: Double blinded randomized controlled trial Methods: Study to be completed at an academic tertiary hospital. Patients must be 6 months of age or younger with a unrepaired complete unilateral cleft lip and palate requiring a primary cheiloplasty. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair. Control subjects will receive a placebo injection in place of the toxin. Surgeons will be blinded to patients that receive the experimental injection. Outcomes will be determined using 3D-videography preoperatively and post operatively at scheduled visits with a total of one year follow up. A scar assessment questionnaire will be completed by parents at select post operative visits. Videography images will also be assessed by a blinded expert panel at the completion of the study.


Inclusion Criteria: Unilateral cleft lip with or without cleft palate, less than 6 months of age Exclusion Criteria: Bilateral cleft lip, older than 6 months of age



Primary Contact:

Principal Investigator
Jaecel O Shah, MD

Jaecel O Shah, MD
Email: jaecel.o.shah@uth.tmc.edu

Backup Contact:

Email: John.F.Teichgraeber@uth.tmc.edu
John F Teichgraeber, MD
Phone: 713.500.7285

Location Contact:

Houston, Texas 77030
United States

Carol Underwood, BSN/RN
Phone: 713-704-4230

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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