Clinical Research Directory
Browse clinical research sites, groups, and studies.
Cleft Lip Scarring After Botox
Sponsor: Children's National Research Institute
Summary
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.
Official title: The Impact of Botulinum Toxin on Scar Formation Following Cleft Lip Repair
Key Details
Gender
All
Age Range
0 Days - 12 Months
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-02-19
Completion Date
2032-02
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Botulinum Toxin Type A (BOTOX) Injection
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
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.
Locations (1)
Children's National Hospital
Washington D.C., District of Columbia, United States