Unilateral Cleft LipNCT07137234
Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.
A study testing Modified Millard rotation advancement flap technique and botulinum toxin injection (BTX A) before surgical intervention in people with Unilateral Cleft Lip, run by Mansoura University at 1 site in Egypt.
Trial summary
the aim of the study will be directed to evaluate clinically the effect of botulinum toxin type A injection on reducing the scar following cleft lip surgical repair. Read more about this study
- Who is it for?
- Ages 10 weeks and older
- Conditions the study is for
- Unilateral Cleft Lip
- What is being tested?
- Modified Millard rotation advancement flap technique and botulinum toxin injection (BTX A) before surgical intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with mild to severe unilateral cleft lip requiring repair
- free from any systemic disease
- with or without cleft palate
- fit for general anesthesia exclusion criteria :
- patients with syndromic type of cleft lip
- patients with systemic disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy: A Randomized Controlled Clinical Trial.
the aim of the study will be directed to evaluate clinically the effect of botulinum toxin type A injection on reducing the scar following cleft lip surgical repair.
- Conditions
- Unilateral Cleft Lip
- Being tested
- Modified Millard rotation advancement flap technique, botulinum toxin injection (BTX A) before surgical intervention
- Keywords
- botulinum toxin, cleft lip, scar
- Medical subject headings
- Cleft Lip, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Millard rotation advancement flap techniqueProcedure or surgery
the cleft is repaired by surgical intervention
botulinum toxin injection (BTX A) before surgical interventionDrug
the patient will receive Botulinum toxin type A followed by surgical closure of cleft lip
| Study group | Role | What they receive |
|---|---|---|
| Group I : 16 patient with unilateral cleft lip treated with surgical procedure alone | Experimental | Not described Receives: Procedure: Modified Millard rotation advancement flap technique |
| Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery | Experimental | Not described Receives: Procedure: Modified Millard rotation advancement flap technique; Drug: botulinum toxin injection (BTX A) before surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar width
Scar width will be measured by independent examiners at two at two certain points using caliper:
point 1 (Bottom) :above the white roll. point 2 (Top): below the nasal sill.
Measured: 3 and 6 months follow up
Secondary outcomes (1)
Vancouver scar scale
it evaluates four factors: pigmentation, pliability, height, and vascularity. it is used to asses treatment.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start15 Mar 2025
- Primary completion15 Mar 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Cleft LipStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basel Saeed Sayed Ahmed Shamaa, Mansoura University
- Investigators
- Basel Saeed Shamaa, Master's, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137234
- Sponsor's protocol ID
- M0101025OS
- Status last verified
- Feb 2026
- First submitted
- 16 Aug 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07137234
- Acronym / sponsor ID
- M0101025OS
- Conditions
- Unilateral Cleft Lip
- Keywords
- botulinum toxin, cleft lip, scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 22 Aug 2025 (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.
the aim of the study will be directed to evaluate clinically the effect of botulinum toxin type A injection on reducing the scar following cleft lip surgical repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I : 16 patient with unilateral cleft lip treated with surgical procedure alone | Experimental | Procedure: Modified Millard rotation advancement flap technique |
| Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery | Experimental | Procedure: Modified Millard rotation advancement flap technique, Drug: botulinum toxin injection (BTX A) before surgical intervention |
Who may qualify
- Ages
- 10 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- patients with mild to severe unilateral cleft lip requiring repair
- free from any systemic disease
- with or without cleft palate
- fit for general anesthesia exclusion criteria :
- patients with syndromic type of cleft lip
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Modified Millard rotation advancement flap techniquethe cleft is repaired by surgical intervention | Procedure or surgery | Group I : 16 patient with unilateral cleft lip treated with surgical procedure alone, Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery |
| botulinum toxin injection (BTX A) before surgical interventionthe patient will receive Botulinum toxin type A followed by surgical closure of cleft lip | Drug | Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery |
Primary outcome
Scar width
Time frame: 3 and 6 months follow up
Scar width will be measured by independent examiners at two at two certain points using caliper: point 1 (Bottom) :above the white roll. point 2 (Top): below the nasal sill.
1 secondary outcome
Vancouver scar scale
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes
Related trials for Unilateral Cleft Lip
Not yet recruiting
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Unilateral Cleft Lip
Not yet recruiting
MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair
Cleft Palate, Cleft Palate, Unilateral, Complete
RecruitingObservational study
Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
Cleft Lip and Cleft Palate
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. This study is not recruiting at the moment.
Basel Saeed Shamaa, Master's principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Millard rotation advancement flap technique and botulinum toxin injection (BTX A) before surgical intervention in people with Unilateral Cleft Lip, run by Mansoura University at 1 site in Egypt.
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 6 inclusion and 0 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: finished, as of the sponsor's last update on 22 Jul 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar width (time frame: 3 and 6 months follow up). 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 22 Jul 2026.