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

Официальное название

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

Обзор

Investigating the efficacy and safety of autologous fat grafting combined with hair transplantation for the treatment of hair loss in patients with localized scleroderma."

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Hair follicle survival rate [Срок оценки: From enrollment to the end of treatment at 12 months]

Вторичные конечные точки (5)

• LoSCAT Score [Срок оценки: From enrollment to the end of treatment at 1, 3, 6 and 12 months]
• Comprehensive efficacy assessment [Срок оценки: From enrollment to the end of treatment at 12 months]
• Patient satisfaction [Срок оценки: From enrollment to the end of treatment at 12 months]
• Quality of life score [Срок оценки: From enrollment to the end of treatment at 12 months]
• Skin biopsy [Срок оценки: From enrollment to the end of treatment at 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• BMI is less than 17, making it impossible to obtain sufficient fat.
• Received new vasodilator or immunosuppressive drug treatment within the past 3 months.
• Applied topical ointments to the surgical area within the past 2 weeks.
• Positive for HIV, HBV, HCV, HTLV-1 or -2, or syphilis.
• Patients with a history of tumor formation in the last 5 years.
• Patients with a prednisolone intake greater than 10 mg/day. Patients deemed unsuitable for participation in this trial by the investigator's judgment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06646146 · NFEC -2024-353

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗