Study on the Efficacy of Autologous Fat Grafting in Improving Hair Transplantation Outcomes for Patients With Localized Scleroderma-Related Alopecia

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."

Study Overview

• Status: Not yet recruiting
• Conditions: Localized Scleroderma; Fat Grafting; Hair Transplantation
• Intervention / Treatment: Procedure: Fat grafting combine with hair transplantation; Procedure: Hair transplantation

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junrong Cai Cai; Phone Number: 86+18565328278; Email: cjr710508@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Hair loss area exceeds one-third of the scalp.
2. Infection of the scalp soft tissue.
3. Suffering from psychiatric disorders, hematologic diseases, immune deficiencies, abnormalities in liver or kidney function, severe hypertension, severe diabetes, and other contraindications for surgery.
4. Women who are pregnant or breastfeeding.
5. BMI is less than 17, making it impossible to obtain sufficient fat.
6. Received new vasodilator or immunosuppressive drug treatment within the past 3 months.
7. Applied topical ointments to the surgical area within the past 2 weeks.
8. Positive for HIV, HBV, HCV, HTLV-1 or -2, or syphilis.
9. Patients with a history of tumor formation in the last 5 years.
10. Patients with a prednisolone intake greater than 10 mg/day. Patients deemed unsuitable for participation in this trial by the investigator's judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fat Graft Combined with Hair Transplantation Group	Procedure: Fat grafting combine with hair transplantation; 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.
Active Comparator: Hair Transplantation Group	Procedure: Hair transplantation; Patients enrolled in this experiment will be divided into two groups. The control group will undergo a simple hair transplantation surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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.	From enrollment to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: localized scleroderma; fat grafting; alopecia; hair transplantation
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Alopecia; Alopecia Areata
• Other Study ID Numbers: NFEC -2024-353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No