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

NCT06646146 | Not Yet Recruiting

• 1 other identifier: NFEC -2024-353
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fat Grafting; Hair Transplantation; Localized Scleroderma

Keywords

fat grafting; localized scleroderma; alopecia; hair transplantation

Outcome Measures

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%.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (5)

• LoSCAT Score

  From enrollment to the end of treatment at 1, 3, 6 and 12 months

• Comprehensive efficacy assessment

  From enrollment to the end of treatment at 12 months

• Patient satisfaction

  From enrollment to the end of treatment at 12 months

• Quality of life score

  From enrollment to the end of treatment at 12 months

• Skin biopsy

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Fat Graft Combined with Hair Transplantation Group

EXPERIMENTAL

Procedure: Fat grafting combine with hair transplantation

Hair Transplantation Group

ACTIVE COMPARATOR

Procedure: Hair transplantation

Interventions

Fat grafting combine with hair transplantation PROCEDURE

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.

Fat Graft Combined with Hair Transplantation Group

Hair transplantation PROCEDURE

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

Hair Transplantation Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patients with clinical symptoms consistent with localized scleroderma (LoSCAT score can be used to assist in diagnosis).
• \. 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.
• \. 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).
• \. The general condition is stable, and the patient can tolerate anesthesia and surgery.
• \. 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.
• \. The subject and their family have given informed consent and have signed the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Scleroderma, Localized; Alopecia

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Junrong Cai Cai

CONTACT

86+18565328278; cjr710508@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: October 31, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share