Home › Cleft Lip and Palate › NCT07880860
Cleft Lip Scarring After Botox
The Impact of Botulinum Toxin on Scar Formation Following Cleft Lip Repair
Who can join
0 Days – 12 Months · All sexes
Full eligibility criteria
Inclusion Criteria: * Infants undergoing cleft lip repair * Age less than 12 months at the time of surgery * Parent or legal guardian able to provide informed consent * Eligible to undergo study procedures and follow-up evaluations Exclusion Criteria: * Known hypersensitivity or contraindication to botulinum toxin type A or any study-related medication components * Medical conditions that would preclude safe participation as determined by the investigator * Previous treatment that may significantly affect scar assessment * Inability to complete required follow-up evaluations * Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results
About the study
This study is investigating whether botulinum toxin type A (Botox) can improve scar appearance after cleft lip repair surgery. Cleft lip repair is commonly performed during infancy, but visible scarring can occur as the incision heals. Botox may reduce muscle movement around the surgical site during healing, which could decrease tension on the wound and improve scar formation.
In this study, infants undergoing cleft lip repair will be randomly assigned to receive either Botox or a placebo injection at the time of surgery. Researchers will evaluate scar appearance during follow-up visits over the first year after surgery and will monitor participants for any treatment-related side effects.
The goal of this study is to determine whether Botox is a safe and effective method for improving scar quality following cleft lip repair.
What is being tested
- Botulinum Toxin Type A (BOTOX) Injection (drug)
- Normal Saline (drug)
Sponsor: Children's National Research Institute · Participants: 40 · Started: Feb 19, 2026
Contact the study team
- Logan Stratton · Phone: 443-922-6012
Official record on ClinicalTrials.gov — NCT07880860
Locations in the U.S.
| District of Columbia | Children's National Hospital, Washington D.C. |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.