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Cleft Lip Scarring After Botox

RecruitingPhase 2Ages 0 Days - 12 MonthsAllChildren's National Research Institute
NCT07880860 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Botulinum Toxin Type A (BOTOX) Injection
  • Normal Saline
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Where

1 site
Children's National Hospital
Washington D.C., United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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