Esthetic Outcome of Injection of Botulinum Toxin Type-A in Cleft Lip RepairNCT03047499
Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleft Lip Repair by Modified Millard Cheiloplasty
An observational study of Esthetic Outcome of Injection of Botulinum Toxin Type-A in Cleft Lip Repair, run by Mostafa Khairy at 1 site in Egypt.
Trial summary
Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of complete unilateral cleftlip repair by modified millard cheiloplasty Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Esthetic Outcome of Injection of Botulinum Toxin Type-A in Cleft Lip Repair
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2017to 15 Nov 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 3 to 6 months
- All sexes
- Child
Study population: Children up to 6 months
Who may be able to join
- Primary cleft lip
Who cannot join
- Cleft palate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 72427
Rehab Tariq Elsharkawy, Dr
About this study
Official title: Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleftlip Repair by Modified Millard Cheiloplasty
Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of complete unilateral cleftlip repair by modified millard cheiloplasty
- Being tested
- Botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type-A injection
| Study group | Role | What they receive |
|---|---|---|
| Scar Length | Not described Receives: Drug: Botulinum toxin type A | |
| Vancouver scar scale | Not described Receives: Drug: Botulinum toxin type A | |
| Scar width | Not described Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Length
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start15 Feb 2017 (estimated)
- Primary completion15 Oct 2017 (estimated)
- Study completion15 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esthetic Outcome of Injection of Botulinum Toxin Type-A in Cleft Lip RepairStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mostafa Khairy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mostafa Khairy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047499
- Sponsor's protocol ID
- CEBC-CU-2017-02-04
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleftlip Repair by Modified Millard Cheiloplasty
- ClinicalTrials.gov ID
- NCT03047499
- Acronym / sponsor ID
- CEBC-CU-2017-02-04
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Mostafa KhairyUniversity, hospital or other
- Study start
- 15 Feb 2017 (estimated)
- Primary completion
- 15 Oct 2017 (estimated)
- Study completion
- 15 Nov 2017 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of complete unilateral cleftlip repair by modified millard cheiloplasty
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scar Length | – | Drug: Botulinum toxin type A |
| Vancouver scar scale | – | Drug: Botulinum toxin type A |
| Scar width | – | Drug: Botulinum toxin type A |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Age groups
- Child
- Study population
- Children up to 6 months
Key inclusion criteria (1 listed)
- Primary cleft lip
Key exclusion criteria (1 listed)
- Cleft palate
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 ABotulinum toxin type-A injection | Drug | Scar Length, Scar width, Vancouver scar scale |
Primary outcome
Scar Length
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esthetic Outcome of Injection of Botulinum Toxin Type-A in Cleft Lip Repair, run by Mostafa Khairy 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Ayman Khairy (00201001155527, mostafakhairy100@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Length (time frame: 6 months). 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 9 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.