Cleft LipDermal RollNCT07624643
Outcome of Alar Base Support in Unilateral Secondary Cleft Lip and Nasal Deformity Repair With Dermal Roll Flap
A study testing surgery in people with Cleft Lip and Nose; Anomaly, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Dermal Roll flap for alar base support Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cleft Lip, Nose; Anomaly, Repair
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Secondary cleft lip and nasal deformity with wide lip scar need revision
Who cannot join
- Bilateral cleft lip secondary deformity
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University Lahore
Lahore, Punjab Province, 54000
About this study
Dermal Roll flap for alar base support
Read the detailed description
Background: Unilateral secondary cleft lip and nasal deformity is almost always associated with under projected cleft side alar base for which augmentation with autologous grafts or synthetic material has been described. Many of such cases with secondary cleft lip and nasal deformity require revision surgery for wide lip scar or vermillion disparities. Objective: During lip revision surgery, some vascularized lip tissue can be spared in the area of previous repair and can be utilized as dermal roll flap for augmentation of alar base. Methodology: This prospective study was conducted on forty-three patients requiring lip scar revision with unilateral secondary cleft lip and nasal deformity having difference of alar base projection of 2 to 5mm measured on basal view photograph. Dermal roll flap was marked, de-epithelized and incised. Tunnel under the alar base was made, insetting of flap was done and lip repair completed. Measurements repeated after 6 months to find out improvement in the projection.
- Conditions
- Cleft Lip, Nose; Anomaly, Repair, Flap Design
- Being tested
- surgery
- Keywords
- Secondary Cleft Lip,, Scar,, Hypoplasia,, Alar Base Projection,, Dermal Roll Flap
- Medical subject headings
- Cleft Lip, Congenital Abnormalities, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
Dermal Roll flap from the lip to support alar base
| Study group | Role | What they receive |
|---|---|---|
| Secondary cleft lip and nasal deformity | Experimental | Patients with Secondary cleft lip and nasal deformity Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alar base projection
Pre and post operative alar base projection will be measured by by drawing horizontal line extending from normal alar base towards columella and crossing towards to cleft side alar base making perpendicular to the vertical line passing through the height of columella.
Difference of cleft side alar base projection will be determined by measuring the distance of alar base central point from the horizontal line.
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 posted3 Jun 2026
- Study start1 Oct 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afzaal Bajwa, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624643
- Sponsor's protocol ID
- 1.CL.2023
- Acronym
- Dermal Roll
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farina R, Lolas J, Moreno E, Alister JP, Uribe MF, Pantoja R, Valladares S, Arrue C. Cleft Lip and Palate Midfacial Hypoplasia: Criteria to Choose the Treatment. J Craniofac Surg. 2022 Mar-Apr 01;33(2):496-501. doi: 10.1097/SCS.0000000000007973.
PubMed 34261964
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Alar Base Support in Unilateral Secondary Cleft Lip and Nasal Deformity Repair With Dermal Roll Flap
- ClinicalTrials.gov ID
- NCT07624643
- Acronym / sponsor ID
- Dermal Roll / 1.CL.2023
- Conditions
- Cleft Lip, Nose; Anomaly, Repair, Flap Design
- Keywords
- Secondary Cleft Lip,, Scar,, Hypoplasia,, Alar Base Projection,, Dermal Roll Flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 3 Jun 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.
Dermal Roll flap for alar base support
Detailed description
Background: Unilateral secondary cleft lip and nasal deformity is almost always associated with under projected cleft side alar base for which augmentation with autologous grafts or synthetic material has been described. Many of such cases with secondary cleft lip and nasal deformity require revision surgery for wide lip scar or vermillion disparities. Objective: During lip revision surgery, some vascularized lip tissue can be spared in the area of previous repair and can be utilized as dermal roll flap for augmentation of alar base. Methodology: This prospective study was conducted on forty-three patients requiring lip scar revision with unilateral secondary cleft lip and nasal deformity having difference of alar base projection of 2 to 5mm measured on basal view photograph. Dermal roll flap was marked, de-epithelized and incised. Tunnel under the alar base was made, insetting of flap was done and lip repair completed. Measurements repeated after 6 months to find out improvement in the projection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secondary cleft lip and nasal deformity | Experimental | Procedure: surgeryPatients with Secondary cleft lip and nasal deformity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Secondary cleft lip and nasal deformity with wide lip scar need revision
Key exclusion criteria (1 listed)
- Bilateral cleft lip secondary deformity
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 |
|---|---|---|
| surgeryDermal Roll flap from the lip to support alar base | Procedure or surgery | Secondary cleft lip and nasal deformity |
Primary outcome
Alar base projection
Time frame: 6 months
Pre and post operative alar base projection will be measured by by drawing horizontal line extending from normal alar base towards columella and crossing towards to cleft side alar base making perpendicular to the vertical line passing through the height of columella. Difference of cleft side alar base projection will be determined by measuring the distance of alar base central point from the horizontal line.
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 3 Jun 2026.
- Background: PubMed 34261964Farina R, Lolas J, Moreno E, Alister JP, Uribe MF, Pantoja R, Valladares S, Arrue C. Cleft Lip and Palate Midfacial Hypoplasia: Criteria to Choose the Treatment. J Craniofac Surg. 2022 Mar-Apr 01;33(2):496-501. doi: 10.1097/SCS.0000000000007973.
- Individual participant dataSharing planned: No
Related trials for Cleft Lip
Not yet recruiting
Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities
Cleft Lip and Nose
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
RecruitingPhase 2
Cleft Lip Scarring After Botox
Cleft Lip, Cleft Lip Scar
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
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 surgery in people with Cleft Lip and Nose; Anomaly, run by King Edward Medical University at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 3 Jun 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 Pakistan. 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?
Alar base projection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07624643, which also lists 1 linked publication.
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 3 Jun 2026.