Cleft LipPhase 2CLSABNCT07880860
Cleft Lip Scarring After Botox
A Phase 2 study testing Botulinum Toxin Type A (BOTOX) Injection and Normal Saline in people with Cleft Lip and Cleft Lip Scar, run by Children's National Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 12 months
- Conditions the study is for
- Cleft Lip, Cleft Lip Scar
- What is being tested?
- Botulinum Toxin Type A (BOTOX) Injection and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2026to Feb 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Logan Stratton, 443-922-6012, stratt2256@gmail.com
About this study
Official title: The Impact of Botulinum Toxin on Scar Formation Following Cleft Lip Repair
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.
Read the detailed description
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.
- Conditions
- Cleft Lip, Cleft Lip Scar
- Being tested
- Botulinum Toxin Type A (BOTOX) Injection, Normal Saline
- Keywords
- Cleft Lip, Cleft Lip Scar, Cheiloplasty, Botulinum Toxin, Botox, Scar Formation, Scar Prevention, Scar Quality, Pediatric Plastic Surgery, Craniofacial Surgery, Cleft Lip Reconstruction
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A (BOTOX) InjectionDrug
Also called Botox, OnabotulinumtoxinA
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 SalineDrug
Also called Placebo, Saline Injection
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.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A | Experimental | 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. Receives: Drug: Botulinum Toxin Type A (BOTOX) Injection |
| Placebo | Placebo comparator | 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after surgery
Secondary outcomes (1)
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.
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start19 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880860
- Sponsor's protocol ID
- 00001365
- Other IDs
- 10,000
- Acronym
- CLSAB
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Botulinum Toxin on Scar Formation Following Cleft Lip Repair
- ClinicalTrials.gov ID
- NCT07880860
- Acronym / sponsor ID
- CLSAB / 00001365
- Conditions
- Cleft Lip, Cleft Lip Scar
- Keywords
- Cleft Lip, Cleft Lip Scar, Cheiloplasty, Botulinum Toxin, Botox, Scar Formation, Scar Prevention, Scar Quality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A | Experimental | Drug: Botulinum Toxin Type A (BOTOX) InjectionParticipants 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 | Placebo comparator | Drug: Normal SalineParticipants 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. |
Who may qualify
- Ages
- 0 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A (BOTOX) InjectionAlso: Botox, OnabotulinumtoxinABotulinum 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. | Drug | Botulinum Toxin Type A |
| Normal SalineAlso: Placebo, Saline InjectionNormal 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. | Drug | Placebo |
Primary outcome
Scar Quality Following Cleft Lip Repair
Time frame: 12 months after surgery
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.
1 secondary outcome
Treatment-Related Adverse Events
Time frame: Up to 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Cleft Lip
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Study on the Supportive Effect of Personalized Nostril Retainer in Unilateral Cleft Lip Surgery
Unilateral Cleft Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
Enrolling by invitationPhase 2
Evaluation of a Novel Nasal Conformer in Pediatric Patients
Cleft Lip, Nasal Surgical Procedures
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxin Type A (BOTOX) Injection and Normal Saline in people with Cleft Lip and Cleft Lip Scar, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Logan Stratton (443-922-6012, lstratton@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Quality Following Cleft Lip Repair (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.