A Phase 2 interventional study of Botulinum Toxin Type A (BOTOX) Injection and Normal Saline in Cleft Lip and Cleft Lip Scar, sponsored by Children's National Research Institute. Recruiting at 1 site in United States. Open to participants aged 0 Days to 12 Months. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Children's National Research Institute · Phase 2, Interventional, and Prevention
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.
Cleft lip is a common congenital craniofacial anomaly that is typically treated with surgical repair during infancy. Although surgical outcomes are generally favorable, postoperative hypertrophic scarring remains a significant clinical concern and may result in aesthetic dissatisfaction, psychosocial effects, and the need for secondary revision procedures. Scar formation may be exacerbated by muscle activity and wound tension across the healing lip.
Botulinum toxin type A (Botox) has been proposed as an adjunctive treatment to improve scar quality by temporarily reducing muscle activity and tension at the surgical site. In addition to its neuromuscular effects, laboratory and clinical studies suggest that botulinum toxin may influence wound healing pathways associated with scar formation. Prior studies have reported improved scar appearance following cleft lip repair with botulinum toxin administration; however, existing evidence is limited by small sample sizes, heterogeneous methodologies, and limited population diversity.
This study is a Phase II, triple-blind, randomized, placebo-controlled clinical trial designed to evaluate the effect of intraoperative botulinum toxin type A on scar formation following cleft lip repair. Infants younger than 1 year of age undergoing cleft lip repair will be randomized to receive either botulinum toxin type A or placebo (normal saline) injections immediately following surgical repair. Participants, caregivers, healthcare providers, and outcome assessors will remain blinded to treatment allocation throughout the study.
Participants will undergo postoperative follow-up at approximately 1, 3, 6, and 12 months after surgery. Scar outcomes will be evaluated using validated scar assessment measures and standardized clinical photographs. Safety monitoring will include evaluation of adverse events potentially related to botulinum toxin administration as well as routine surgical complications.
The goal of this study is to determine whether botulinum toxin administration at the time of cleft lip repair improves long-term scar quality while maintaining an acceptable safety profile. Results may help guide future approaches to scar prevention and optimization of aesthetic outcomes in patients with cleft lip.
167 studies on the registry are indexed under Cleft Lip; 53 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 117 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
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.
Drug: Botulinum Toxin Type A (BOTOX) Injection
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.
Drug: Normal Saline
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.
Also known as: Botox, OnabotulinumtoxinA
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.
Also known as: Placebo, Saline Injection
Scar Quality Following Cleft Lip Repair
Scar quality will be assessed using standardized postoperative scar evaluation methods and clinical photographs to compare scar appearance between participants receiving botulinum toxin type A and those receiving placebo following cleft lip repair.
Time frame: 12 months after surgery
Treatment-Related Adverse Events
The incidence and severity of adverse events potentially related to botulinum toxin type A administration following cleft lip repair will be assessed and compared between the treatment and placebo groups.
Time frame: Up to 12 months after surgery
Plan to share: Undecided — The investigators have not yet determined whether individual participant data (IPD) will be shared. Any future data-sharing decisions will be made in accordance with institutional policies, participant privacy requirements, and applicable regulations.
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Studies of the drug tested here: Botulinum toxin type A
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