About this trial
Investigating the efficacy and safety of autologous fat grafting combined with hair transplantation for the treatment of hair loss in patients with localized scleroderma."
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Patients with clinical symptoms consistent with localized scleroderma (LoSCAT score can be used to assist in diagnosis).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Fat grafting combine with hair transplantation
Procedure/SurgeryPatients 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 transplantation
Procedure/SurgeryPatients enrolled in this experiment will be divided into two groups. The control group will undergo a simple hair transplantation surgery.
Treatment groups
Trial outcomes
Primary outcomes
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%.
Secondary outcomes
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.
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.
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
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
Locations
Sponsors and contacts
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