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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorNanfang Hospital, Southern Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Fat grafting combine with hair transplantation

    Procedure/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 transplantation

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Fat Graft Combined with Hair Transplantation GroupExperimental treatment 1 intervention
Group B: Hair Transplantation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Time frame
From enrollment to the end of treatment at 12 months
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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