Port Wine StainsmacrocheiliaNCT07128459
Lip Reduction Surgery for Port-wine Macrocheilia
A study testing The Five-Step lip reduction surgery in people with Port Wine Stains, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Patients with port-wine stains often develop macrocheilia, however, there is currently no effective treatment to significantly reduce the three-dimensional volume increase of the lips. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Port Wine Stains
- What is being tested?
- The Five-Step lip reduction surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Jul 2025
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: 1. Patients with port-wine macrocheilia. 2. Patients that underwent lip reduction surgery. 3. Age at surgery: ≥3 years and ≤70 years.
Exclusion Criteria: 1. Patients without port-wine macrocheilia. 2. Missing/incomplete baseline patient information. 3. Patients without postoperative photographs.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai
About this study
Official title: Lip Reduction Surgery for Port-wine Macrocheilia: a Retrospective Single-center Clinical Study
Patients with port-wine stains often develop macrocheilia, however, there is currently no effective treatment to significantly reduce the three-dimensional volume increase of the lips. This article presents a simplified "five-step" approach based on clinical experience, designed to assist inexperienced surgeons in performing this surgery effectively.
- Conditions
- Port Wine Stains
- Being tested
- The Five-Step lip reduction surgery
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Five-Step lip reduction surgeryProcedure or surgery
The Five-Step lip reduction surgery: (1) measurement and design; (2) incision and reduction of lip volume; (3) fixation and shape of the dry lip; (4) fixation and shape of the skin (the SMISS approach); (5) shaping of the wet lip mucosa (the SMISS approach).
| Study group | Role | What they receive |
|---|---|---|
| Patients with port-wine macrocheilia who underwent lip reduction surgery using the five-step method | Experimental | Not described Receives: Procedure: The Five-Step lip reduction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Visual Analog Scale
Measured: From enrollment to the end of treatment in 6 months to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Jan 2020
- Primary completion30 Apr 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port Wine StainsStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Ma, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128459
- Sponsor's protocol ID
- SH9H-2025-T313-1
- Acronym
- macrocheilia
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lip Reduction Surgery for Port-wine Macrocheilia: a Retrospective Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT07128459
- Acronym / sponsor ID
- macrocheilia / SH9H-2025-T313-1
- Conditions
- Port Wine Stains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 19 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.
Patients with port-wine stains often develop macrocheilia, however, there is currently no effective treatment to significantly reduce the three-dimensional volume increase of the lips. This article presents a simplified "five-step" approach based on clinical experience, designed to assist inexperienced surgeons in performing this surgery effectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with port-wine macrocheilia who underwent lip reduction surgery using the five-step method | Experimental | Procedure: The Five-Step lip reduction surgery |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| The Five-Step lip reduction surgeryThe Five-Step lip reduction surgery: (1) measurement and design; (2) incision and reduction of lip volume; (3) fixation and shape of the dry lip; (4) fixation and shape of the skin (the SMISS approach); (5) shaping of the wet lip mucosa (the SMISS approach). | Procedure or surgery | Patients with port-wine macrocheilia who underwent lip reduction surgery using the five-step method |
Primary outcome
the Visual Analog Scale
Time frame: From enrollment to the end of treatment in 6 months to one year
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 19 Aug 2025.
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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 The Five-Step lip reduction surgery in people with Port Wine Stains, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Aug 2025. 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 China. 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?
the Visual Analog Scale (time frame: From enrollment to the end of treatment in 6 months to one year). 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 Aug 2025.