Cleft LipNCT05559281
Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair
A study testing Botulinum and Fisher technique in people with Cleft Lip, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Read more about this study
- Who is it for?
- Ages 0 minutes to 1 year
- Conditions the study is for
- Cleft Lip
- What is being tested?
- Botulinum and Fisher technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Oct 2022
- 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 0 minutes to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- With mild to severe cleft lip deformity requiring repair.
- Neonates up to 1 year of age.
- Patients with or without cleft palate.
- Systemically healthy patients.
- Patients follow postoperative instructions provided by their legal guardians.
Who cannot join
- Patients with a syndromic type of cleft lip.
- Patients suffering from relevant systemic and metabolic diseases.
- Patients suffering from immunosuppressive diseases.
- Patients suffering from neuromuscular disorders like Myasthenia Gravis.
- Patients with special needs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)
A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method
- Conditions
- Cleft Lip
- Being tested
- Botulinum, Fisher technique
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotulinumOther
injection of Botulinum Toxin injection in lip muscles following cleft lip repair surgically.
Fisher techniqueProcedure or surgery
The cleft lip will be treated surgically using the Fisher technique only.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Other: Botulinum |
| Group B | Active comparator | Not described Receives: Procedure: Fisher technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cleft scar
Vancouver Scar Scale: This scale focuses on four parameters:
scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 point
Measured: 2 weeks, 3 months, 6 months
Secondary outcomes (2)
Change in scar width
The scar width is to be measured at two certain points using digital caliper, one point is 1 mm above white line and the second point is 1 mm below nasal
Measured: 2 weeks, 3 months, 6 months
Change in lip height
The lip height measurement will be done using digital caliper at cleft and non-cleft side.
Measured: 2 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Jul 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559281
- Sponsor's protocol ID
- Botulinum_2020
- Status last verified
- Oct 2022
- First submitted
- 25 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05559281
- Acronym / sponsor ID
- Botulinum_2020
- Conditions
- Cleft Lip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 29 Sep 2022 (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.
A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Botulinum |
| Group B | Active comparator | Procedure: Fisher technique |
Who may qualify
- Ages
- 0 minutes to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- With mild to severe cleft lip deformity requiring repair.
- Neonates up to 1 year of age.
- Patients with or without cleft palate.
- Systemically healthy patients.
- Patients follow postoperative instructions provided by their legal guardians.
Key exclusion criteria (5 listed)
- Patients with a syndromic type of cleft lip.
- Patients suffering from relevant systemic and metabolic diseases.
- Patients suffering from immunosuppressive diseases.
- Patients suffering from neuromuscular disorders like Myasthenia Gravis.
- Patients with special needs.
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 |
|---|---|---|
| Botulinuminjection of Botulinum Toxin injection in lip muscles following cleft lip repair surgically. | Other | Group A |
| Fisher techniqueThe cleft lip will be treated surgically using the Fisher technique only. | Procedure or surgery | Group B |
Primary outcome
Change in cleft scar
Time frame: 2 weeks, 3 months, 6 months
Vancouver Scar Scale: This scale focuses on four parameters: scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 point
2 secondary outcomes
Change in scar width
Time frame: 2 weeks, 3 months, 6 months
Change in lip height
Time frame: 2 weeks, 3 months, 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 4 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum and Fisher technique in people with Cleft Lip, run by Hams Hamed Abdelrahman 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 5 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: finished, as of the sponsor's last update on 4 Oct 2022. 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?
Change in cleft scar (time frame: 2 weeks, 3 months, 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 4 Oct 2022.