Investigating the efficacy and safety of autologous fat grafting combined with hair transplantation for the treatment of hair loss in patients with localized scleroderma."
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Patients enrolled in this experiment will be divided into two groups. The control group will undergo a simple hair transplantation surgery.
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%.
Time frame: From enrollment to the end of treatment at 12 months
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.
Time frame: 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.
Time frame: 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
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Time frame: 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
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 months