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

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Oct 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people with localized scleroderma who are experiencing hair loss. Specifically, researchers want to see if using fat taken from the patient’s own body (called autologous fat grafting) can improve the results of hair transplantation in these patients. Localized scleroderma is a condition that can cause patches of skin to become hard and can lead to hair loss in those areas. The goal of this study is to determine how effective and safe this combined treatment is for restoring hair growth.

To be eligible for this trial, participants must be between 18 and 59 years old and have been diagnosed with localized scleroderma-related hair loss for more than six months. They should have a stable condition with no active symptoms for at least a year, and they must be in good overall health to undergo surgery. Participants will need to be able to follow care instructions after the procedure. This trial is not yet recruiting, but it aims to provide new hope for those struggling with hair loss due to this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 1. Hair loss area exceeds one-third of the scalp.
• • 2. Infection of the scalp soft tissue.
• • 3. Suffering from psychiatric disorders, hematologic diseases, immune deficiencies, abnormalities in liver or kidney function, severe hypertension, severe diabetes, and other contraindications for surgery.
• • 4. Women who are pregnant or breastfeeding.
• • 5. BMI is less than 17, making it impossible to obtain sufficient fat.
• • 6. Received new vasodilator or immunosuppressive drug treatment within the past 3 months.
• • 7. Applied topical ointments to the surgical area within the past 2 weeks.
• • 8. Positive for HIV, HBV, HCV, HTLV-1 or -2, or syphilis.
• • 9. Patients with a history of tumor formation in the last 5 years.
• • 10. Patients with a prednisolone intake greater than 10 mg/day. Patients deemed unsuitable for participation in this trial by the investigator's judgment.