Hemifacial AtrophyNCT07305909
Two- and Three-Dimensional Quantification of Facial Symmetry After Fat Grafting and Free Flap Reconstruction in Hemifacial Atrophy
An observational study of Hemifacial Atrophy, run by Peking Union Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemifacial Atrophy
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2020to 29 Dec 2023
- Phase
- Observational
- 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
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100144
About this study
Official title: Two- and Three-Dimensional Quantification of Facial Symmetry Following Fat Grafting Versus Free Flap Reconstruction in Hemifacial Atrophy: A Retrospective Observational Study
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.
- Conditions
- Hemifacial Atrophy
- Medical subject headings
- Facial Hemiatrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperative) and first follow-up visit 6 months postoperatively
Secondary outcomes (1)
Change in 3D Volumetric Discrepancy Between Hemifaces
Three-dimensional (3D) volumetric discrepancy between the affected and unaffected hemiface measured from 3D surface scans in the subset of participants with available 3D data. Change from baseline to the first ≥6-month follow-up visit.
Measured: Baseline (preoperative) and first follow-up visit 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start10 Jan 2020
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemifacial AtrophyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Responsible party
- Principal investigator, Xiaolei Jin, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305909
- Sponsor's protocol ID
- 2024-344
- Other IDs
- 2024-344
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two- and Three-Dimensional Quantification of Facial Symmetry Following Fat Grafting Versus Free Flap Reconstruction in Hemifacial Atrophy: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07305909
- Acronym / sponsor ID
- 2024-344
- Conditions
- Hemifacial Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 26 Dec 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in 2D Facial Symmetry Ratio
Time frame: Baseline (preoperative) and first follow-up visit 6 months postoperatively
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.
1 secondary outcome
Change in 3D Volumetric Discrepancy Between Hemifaces
Time frame: Baseline (preoperative) and first follow-up visit 6 months postoperatively
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 26 Dec 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?
An observational study of Hemifacial Atrophy, run by Peking Union Medical College 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?
The sponsor lists 3 inclusion and 3 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 26 Dec 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?
Change in 2D Facial Symmetry Ratio (time frame: Baseline (preoperative) and first follow-up visit 6 months postoperatively). 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 26 Dec 2025.