Botox to improve scar after cleft lip repair
Official title: The Impact of Botulinum Toxin on Scar Formation Following Cleft Lip Repair
Run by Children's National Research Institute · NCT07880860 · Data updated 2026-11-12
This study tests whether a Botox injection given during cleft lip repair in infants can lead to better-looking scars in the first year after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 0 Days to 12 Months |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | February 19, 2026 |
| Main results expected | February 2027 |
| Study ends | February 2032 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT07880860 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants under 12 months old undergoing cleft lip repair and whose parent or guardian can provide informed consent.
✕Probably not a fit
Some infants may not see a meaningful scar improvement or may experience no difference compared with placebo.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase II, triple-blind, randomized, placebo-controlled trial will compare intraoperative botulinum toxin type A to normal saline in infants undergoing cleft lip repair. Participants, caregivers, and clinicians assessing outcomes will be unaware of treatment assignment. The study will follow wound healing and scar appearance for up to 12 months, monitoring safety and any treatment-related side effects. The goal is to determine if reducing muscle activity around the healing lip improves scar quality.
Why it matters
Potential benefit: If successful, the intervention could lead to more favorable scar outcomes after cleft lip repair.
How similar studies have gone: Previous smaller studies have explored botulinum toxin for scar improvement with mixed results; this trial aims to provide clearer evidence in a larger, diverse infant population.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Children's National Hospital
Washington D.C., District of Columbia, United States Recruiting
Study contacts
- Study coordinator: Logan Stratton
- Email: lstratton@childrensnational.org
- Phone: 443-922-6012
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.