Improvement of the Appearance of Cleft Lip Scars Using Botox



Status:Recruiting
Conditions:Cosmetic, Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:5/24/2018
Start Date:December 2015
End Date:December 31, 2019
Contact:Jaecel O Shah, MD
Email:jaecel.o.shah@uth.tmc.edu

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Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair

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
We found this trial at
1
site
Houston, Texas 77030
Phone: 713-704-4230
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Houston, TX
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