Recruiting
Phase 2

Botox

Sponsor:

Children's National Research Institute

Code:

NCT07880860

Conditions

Cleft Lip

Cleft Lip Scar

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Botulinum Toxin Type A (BOTOX) Injection

Normal Saline

Study Details

Brief 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.

Conditions

Cleft Lip

Cleft Lip Scar

Study ID

NCT07880860

Start date

Feb 19, 2026

Status verified date

Oct, 2026

Completion date

Feb, 2032

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Botulinum Toxin Type A

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.

placebo comparator: Placebo

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.

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.

Primary outcome measure

  • Scar Quality Following Cleft Lip Repair [ Time Frame: 12 months after surgery ]

Central Contacts and Locations

Central contacts

Logan Stratton

443-922-6012lstratton@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Logan Stratton

443-922-6012stratt2256@gmail.com

More Information

Sponsor

Children's National Research Institute

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Cleft Lip
  • Cleft Lip Scar
  • Cheiloplasty
  • Botulinum Toxin
  • Botox
  • Scar Formation
  • Scar Prevention
  • Scar Quality
  • Pediatric Plastic Surgery
  • Craniofacial Surgery
  • Cleft Lip Reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.