NCT07128459

Brief 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. This article presents a simplified "five-step" approach based on clinical experience, designed to assist inexperienced surgeons in performing this surgery effectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

5.3 years

First QC Date

August 13, 2025

Last Update Submit

August 13, 2025

Conditions

Port Wine Stains

Outcome Measures

Primary Outcomes (1)

  • the Visual Analog Scale

    From enrollment to the end of treatment in 6 months to one year

Study Arms (1)

Patients with port-wine macrocheilia who underwent lip reduction surgery using the five-step method

EXPERIMENTAL
Procedure: The Five-Step lip reduction surgery

Interventions

The Five-Step lip reduction surgeryPROCEDURE

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).

Patients with port-wine macrocheilia who underwent lip reduction surgery using the five-step method

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

HemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 19, 2025

Study Start

January 1, 2020

Primary Completion

April 30, 2025

Study Completion

July 31, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations

CN(1)