Botox for Cleft Lip Scar
(CLSAB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for infants who are having surgery to repair a cleft lip. Babies with other major health issues or conditions that could affect healing may not be able to participate.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Botulinum Toxin Type A (BOTOX) Injection
Trial Overview
The study compares Botox injections versus placebo (salt water) given during cleft lip surgery to see if Botox helps improve the appearance of scars as the wound heals. Infants are randomly assigned to one of the two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants undergoing cleft lip repair receive intraoperative botulinum toxin type A injections at the time of surgical repair. Scar outcomes and adverse events are assessed during postoperative follow-up.
Participants undergoing cleft lip repair receive intraoperative placebo (normal saline) injections at the time of surgical repair. Scar outcomes and adverse events are assessed during postoperative follow-up.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's National Research Institute
Lead Sponsor
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