Fat GraftingNCT06646146
Study on the Efficacy of Autologous Fat Grafting in Improving Hair Transplantation Outcomes for Patients With Localized Scleroderma-Related Alopecia
A study testing Fat grafting combine with hair transplantation and Hair transplantation in people with Fat Grafting and Hair Transplantation, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Investigating the efficacy and safety of autologous fat grafting combined with hair transplantation for the treatment of hair loss in patients with localized scleroderma." Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Fat Grafting, Hair Transplantation, Localized Scleroderma
- What is being tested?
- Fat grafting combine with hair transplantation and Hair transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2024to 3 Sep 2026
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients with clinical symptoms consistent with localized scleroderma (LoSCAT score can be used to assist in diagnosis).
- 2. Diagnosed with secondary alopecia caused by localized scleroderma. 3. A history of hair loss in the affected area for more than 6 months, with an adequate supply of donor hair.
- 4. The disease is inactive and has been in a stationary phase for over a year (patients have no ongoing or intermittent hair loss accompanied by local pain, itching, or burning; scalp biopsy indicates no inflammatory cell infiltration, hair follicle orifices have disappeared, and hair follicles are replaced by connective tissue).
- 5. The general condition is stable, and the patient can tolerate anesthesia and surgery.
- 6. BMI is greater than or equal to 17. 7. Age between 18 and 59. 8. The subject and their family are willing and able to comply with postoperative care and follow-up requirements.
- 9. The subject and their family have given informed consent and have signed the informed consent form.
Who cannot join
- Hair loss area exceeds one-third of the scalp.
- Infection of the scalp soft tissue.
- Suffering from psychiatric disorders, hematologic diseases, immune deficiencies, abnormalities in liver or kidney function, severe hypertension, severe diabetes, and other contraindications for surgery.
- Women who are pregnant or breastfeeding.
- BMI is less than 17, making it impossible to obtain sufficient fat.
- Received new vasodilator or immunosuppressive drug treatment within the past 3 months.
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- Applied topical ointments to the surgical area within the past 2 weeks.
- Positive for HIV, HBV, HCV, HTLV-1 or -2, or syphilis.
- Patients with a history of tumor formation in the last 5 years.
- Patients with a prednisolone intake greater than 10 mg/day. Patients deemed unsuitable for participation in this trial by the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Prospective, Randomized Controlled Clinical Study on the Efficacy of Autologous Fat Grafting in Improving Hair Transplantation Outcomes for Patients With Localized Scleroderma-Related Alopecia
Investigating the efficacy and safety of autologous fat grafting combined with hair transplantation for the treatment of hair loss in patients with localized scleroderma."
Read the detailed description
Localized scleroderma is an autoimmune disorder affecting the connective tissue, with skin fibrosis being the primary symptom, potentially leading to skin hardening, atrophy, and hair loss.For facial deformities associated with localized scleroderma, current treatments primarily involve medication, which can ameliorate disease activity but does not reverse the condition. Hair transplantation can improve alopecia, although the survival rate of hair follicles in patients with scleroderma may be lower than in the general population.
Autologous fat grafting is a plastic surgery technique used for soft tissue augmentation and tissue regeneration. The stem cells and growth factors present in adipose tissue contribute to hair regrowth. Studies have indicated that autologous fat grafting, when used adjunctively with hair transplantation, can enhance the survival rate of hair follicles and increase patient satisfaction.Our research team has developed a patented adipose matrix vascular component known as ECM/SVF-gel. This component is rich in active cells and holds potential for regenerative medicine. It has been widely applied clinically to effectively ameliorate scar fibrosis and promote wound healing.
Based on existing research, we hypothesize that fat grafting may improve hair loss in patients with localized scleroderma and increase the survival rate of hair follicles. We plan to conduct a randomized controlled study comparing hair transplantation assisted by ECM/SVF-gel with traditional hair transplantation to validate our hypothesis and provide a more effective treatment option for patients with scleroderma.
- Conditions
- Fat Grafting, Hair Transplantation, Localized Scleroderma
- Being tested
- Fat grafting combine with hair transplantation, Hair transplantation
- Keywords
- fat grafting, localized scleroderma, alopecia, hair transplantation
- Medical subject headings
- Scleroderma, Localized, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat grafting combine with hair transplantationProcedure or surgery
Patients enrolled in this experiment will be divided into two groups.The experimental group will have autologous fat tissue harvested during surgery for fat grafting in the patient's alopecia area, and a subsequent hair transplantation will be performed after three months when the transplanted fat has stabilized and survived.
Hair transplantationProcedure or surgery
Patients enrolled in this experiment will be divided into two groups. The control group will undergo a simple hair transplantation surgery.
| Study group | Role | What they receive |
|---|---|---|
| Fat Graft Combined with Hair Transplantation Group | Experimental | Not described Receives: Procedure: Fat grafting combine with hair transplantation |
| Hair Transplantation Group | Active comparator | Not described Receives: Procedure: Hair transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair follicle survival rate
Number of follicular units per square centimeter at 12 months post-surgery divided by the number of transplanted follicular units per square centimeter immediately post-surgery, multiplied by 100%.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (5)
LoSCAT Score
Observe the skin lesion conditions of the treatment area before and after treatment, and assess using the LoSCAT scale at 1, 3, 6, and 12 months post-surgery.
Measured: From enrollment to the end of treatment at 1, 3, 6 and 12 months
Comprehensive efficacy assessment
Observe and record the hair growth conditions of patients in both groups after surgery and during the follow-up period, and collect relevant statistical data. A comprehensive evaluation is conducted based on four aspects: the coverage rate of the bald area 12 months after surgery, surgical scars, hair density, and hair growth direction. The medical aesthetic effect is evaluated by physicians: Excellent: The bald area is completely covered, the design line is natural and aesthetically pleasing, with no surgical scars, even hair density, and the growth direction is basically consistent with the original hair growth direction; Good: The coverage area of the bald area is ≥80%, with no obvious surgical scars, and the hair density is basically even; Poor: The coverage area of the bald area is <80%, with residual surgical scars, uneven hair density, and disordered hair growth direction. Aesthetics = Excellent + Good.
Measured: From enrollment to the end of treatment at 12 months
Patient satisfaction
At the 12-month follow-up after surgery, a self-made questionnaire is used to evaluate the satisfaction of patients and their families with the post-treatment hair growth in both groups. The scoring range is 0~100 points, divided into five levels: Very Satisfied (85~100 points, including 85 points), Satisfied (70-85 points, including 70 points), Generally Satisfied (55-70 points, including 55 points), Dissatisfied (40-55 points, including 40 points), Very Dissatisfied (below 40 points). Record the patient satisfaction and calculate the patient satisfaction rate
Measured: From enrollment to the end of treatment at 12 months
Quality of life score
Before the start of treatment and 12 months after surgery, the DLQI questionnaire is used to score the quality of life of patients in both groups, with the score increasing as the patient's quality of life improves
Measured: From enrollment to the end of treatment at 12 months
Skin biopsy
Histological assessment of the degree of inflammation and fibrosis in the hair transplant area is conducted 12 months after surgery.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start5 Dec 2024
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat GraftingStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646146
- Sponsor's protocol ID
- NFEC -2024-353
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Randomized Controlled Clinical Study on the Efficacy of Autologous Fat Grafting in Improving Hair Transplantation Outcomes for Patients With Localized Scleroderma-Related Alopecia
- ClinicalTrials.gov ID
- NCT06646146
- Acronym / sponsor ID
- NFEC -2024-353
- Conditions
- Fat Grafting, Hair Transplantation, Localized Scleroderma
- Keywords
- fat grafting, localized scleroderma, alopecia, hair transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 17 Oct 2024 (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.
Investigating the efficacy and safety of autologous fat grafting combined with hair transplantation for the treatment of hair loss in patients with localized scleroderma."
Detailed description
Localized scleroderma is an autoimmune disorder affecting the connective tissue, with skin fibrosis being the primary symptom, potentially leading to skin hardening, atrophy, and hair loss.For facial deformities associated with localized scleroderma, current treatments primarily involve medication, which can ameliorate disease activity but does not reverse the condition. Hair transplantation can improve alopecia, although the survival rate of hair follicles in patients with scleroderma may be lower than in the general population.
Autologous fat grafting is a plastic surgery technique used for soft tissue augmentation and tissue regeneration. The stem cells and growth factors present in adipose tissue contribute to hair regrowth. Studies have indicated that autologous fat grafting, when used adjunctively with hair transplantation, can enhance the survival rate of hair follicles and increase patient satisfaction.Our research team has developed a patented adipose matrix vascular component known as ECM/SVF-gel. This component is rich in active cells and holds potential for regenerative medicine. It has been widely applied clinically to effectively ameliorate scar fibrosis and promote wound healing.
Based on existing research, we hypothesize that fat grafting may improve hair loss in patients with localized scleroderma and increase the survival rate of hair follicles. We plan to conduct a randomized controlled study comparing hair transplantation assisted by ECM/SVF-gel with traditional hair transplantation to validate our hypothesis and provide a more effective treatment option for patients with scleroderma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fat Graft Combined with Hair Transplantation Group | Experimental | Procedure: Fat grafting combine with hair transplantation |
| Hair Transplantation Group | Active comparator | Procedure: Hair transplantation |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1. Patients with clinical symptoms consistent with localized scleroderma (LoSCAT score can be used to assist in diagnosis).
- 2. Diagnosed with secondary alopecia caused by localized scleroderma. 3. A history of hair loss in the affected area for more than 6 months, with an adequate supply of donor hair.
- 4. The disease is inactive and has been in a stationary phase for over a year (patients have no ongoing or intermittent hair loss accompanied by local pain, itching, or burning; scalp biopsy indicates no inflammatory cell infiltration, hair follicle orifices have disappeared, and hair follicles are replaced by connective tissue).
- 5. The general condition is stable, and the patient can tolerate anesthesia and surgery.
- 6. BMI is greater than or equal to 17. 7. Age between 18 and 59. 8. The subject and their family are willing and able to comply with postoperative care and follow-up requirements.
Key exclusion criteria (10 listed)
- Hair loss area exceeds one-third of the scalp.
- Infection of the scalp soft tissue.
- Suffering from psychiatric disorders, hematologic diseases, immune deficiencies, abnormalities in liver or kidney function, severe hypertension, severe diabetes, and other contraindications for surgery.
- Women who are pregnant or breastfeeding.
- BMI is less than 17, making it impossible to obtain sufficient fat.
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 |
|---|---|---|
| Fat grafting combine with hair transplantationPatients enrolled in this experiment will be divided into two groups.The experimental group will have autologous fat tissue harvested during surgery for fat grafting in the patient's alopecia area, and a subsequent hair transplantation will be performed after three months when the transplanted fat has stabilized and survived. | Procedure or surgery | Fat Graft Combined with Hair Transplantation Group |
| Hair transplantationPatients enrolled in this experiment will be divided into two groups. The control group will undergo a simple hair transplantation surgery. | Procedure or surgery | Hair Transplantation Group |
Primary outcome
Hair follicle survival rate
Time frame: From enrollment to the end of treatment at 12 months
Number of follicular units per square centimeter at 12 months post-surgery divided by the number of transplanted follicular units per square centimeter immediately post-surgery, multiplied by 100%.
5 secondary outcomes
LoSCAT Score
Time frame: From enrollment to the end of treatment at 1, 3, 6 and 12 months
Comprehensive efficacy assessment
Time frame: From enrollment to the end of treatment at 12 months
Patient satisfaction
Time frame: From enrollment to the end of treatment at 12 months
Quality of life score
Time frame: From enrollment to the end of treatment at 12 months
Skin biopsy
Time frame: From enrollment to the end of treatment at 12 months
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 24 Sep 2026.
- Individual participant dataSharing planned: No
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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 Fat grafting combine with hair transplantation and Hair transplantation in people with Fat Grafting and Hair Transplantation, run by Nanfang Hospital, Southern Medical 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?
The sponsor lists 6 inclusion and 10 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 24 Sep 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 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?
Hair follicle survival rate (time frame: From enrollment to the end of treatment at 12 months). 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 24 Sep 2026.