RECRUITING Phase 2 ClinicalTrials.gov

Cleft Lip Scarring After Botox

Sponsor: Children's National Research Institute • ClinicalTrials.gov ID: NCT07880860

Registry updated: 2026-10-19

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Description

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.

Interventions

Botulinum Toxin Type A (BOTOX) Injection (Drug)
Botulinum toxin type A is administered intraoperatively following cleft lip repair to temporarily reduce muscle activity and tension across the surgical incision. The intervention is intended to improve wound healing and reduce postoperative scar formation. Participants are monitored during routine follow-up visits to assess scar quality and safety outcomes.
Normal Saline (Drug)
Normal saline is administered intraoperatively following cleft lip repair as a placebo comparator. Participants are monitored during routine follow-up visits to assess scar quality and safety outcomes.

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

Conditions

Cleft Lip Cleft Lip Scar

Locations

Children's National Hospital — Washington D.C., District of Columbia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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