NCT06646146

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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."

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

Interventions

Type	Name	Description
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.
PROCEDURE	Hair transplantation	Patients enrolled in this experiment will be divided into two groups. The control group will undergo a simple hair transplantation surgery.

Timeline

• Start date: 2024-10-31
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2024-10-17
• Last updated: 2024-10-17