NCT07305909

Brief Summary

Hemifacial atrophy causes one side of the face to become smaller, leading to facial asymmetry. Surgeons often restore facial volume using either autologous fat grafting or free-flap reconstruction. However, it is not fully clear how much facial symmetry improves after surgery when measured objectively using two-dimensional (2D) photographs and three-dimensional (3D) surface scans. This is a single-center, retrospective observational study of patients with hemifacial atrophy treated between January 2020 and December 2023 at \[Plastic Surgery Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College\]. We will quantify facial symmetry before surgery and at the first follow-up visit occurring at or beyond 6 months after the initial surgery. Symmetry outcomes will be assessed using standardized 2D photographs for all included patients, and 3D surface scans for a subset of patients. Complications will also be assessed at the first ≥6-month follow-up visit. We will compare changes in symmetry between patients treated with fat grafting and those treated with free-flap reconstruction.

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 all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

December 13, 2025

Last Update Submit

December 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in 2D Facial Symmetry Ratio

    Facial symmetry ratio calculated from standardized frontal 2D photographs using computerized photogrammetric analysis. The primary endpoint is the change from preoperative baseline to the first postoperative follow-up visit occurring at or beyond 6 months after the initial surgery.

    Baseline (preoperative) and first follow-up visit 6 months postoperatively

Secondary Outcomes (1)

  • Change in 3D Volumetric Discrepancy Between Hemifaces

    Baseline (preoperative) and first follow-up visit 6 months postoperatively

Study Arms (2)

Fat Grafting

Patients with hemifacial atrophy who underwent autologous fat grafting as the initial soft-tissue augmentation procedure. Outcomes were assessed preoperatively and at the first follow-up visit occurring ≥6 months postoperatively.

Free Flap Reconstruction (ALT)

Patients with hemifacial atrophy who underwent anterolateral thigh (ALT) free-flap reconstruction as the initial soft-tissue augmentation procedure. Outcomes were assessed preoperatively and at the first follow-up visit occurring ≥6 months postoperatively.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hemifacial atrophy treated at a single center between January 2020 and December 2023 who underwent initial facial volume restoration using autologous fat grafting or free-flap reconstruction. Outcomes were assessed preoperatively and at the first follow-up visit ≥6 months postoperatively. Three-dimensional surface scan analysis was performed in a subset with available 3D data.

You may qualify if:

  • Diagnosis of hemifacial atrophy (Parry-Romberg syndrome).
  • Underwent initial soft-tissue augmentation with either autologous fat grafting or free-flap reconstruction at the study center between January 2020 and December 2023.
  • Availability of standardized preoperative assessment and postoperative assessment at the first follow-up visit occurring ≥6 months after surgery (2D photographs required).

You may not qualify if:

  • Follow-up \<6 months after the initial surgery.
  • Missing key imaging/photographic data required for outcome assessment.
  • Any additional facial augmentation or revision procedure performed before the first ≥6-month follow-up visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100144, China

Location

MeSH Terms

Conditions

Facial Hemiatrophy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician, Professor of Plastic Surgery

Study Record Dates

First Submitted

December 13, 2025

First Posted

December 26, 2025

Study Start

January 10, 2020

Primary Completion

December 29, 2023

Study Completion

December 29, 2023

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations