Skip to content

Safety and efficacy of hair follicle derived melanocyte regeneration in the treatment of stable vitiligo: a prospective study

Safety and efficacy of hair follicle derived melanocyte regeneration in the treatment of stable vitiligo: a prospective study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044397
Enrollment
Unknown
Registered
2021-03-17
Start date
2019-08-01
Completion date
Unknown
Last updated
2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo

Interventions

Case series:transplantation of hair follicle melanocyte suspension

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Stable vitiligo patients, indicated by at least 2 of the following 4 criterias: (1) the VIDA score is 0 point; (2) clinical features: porcelain white spots with sharpened edges or pigmentation; (3) no evidence of Koebner Phenomenon for not less than a year; (4) evidenced by the wood lamp: the lesion is white in color, with sharpened edges; the lesion area is not more than that measured by visual inspection; 2. Aged between 18 and 65 years; 3. The lesion is less than 10% of body surface area, non-exposed; 4. Other treatments have been ineffective for the last year, including glucocorticoids, phototherapy, laser therapy, topical vitamin D3 derivatives, topical calcineurin inhibitors; 5. Subjects volunteer and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with keloidal tendency; 2. Patients with sebrrheic alopecia; 3. Patients with autoimmune diseases such as lupus erythematosus, scleroderma, dermatomyositis; 4. Pregnancy or planning pregnancy during the study period; 5. Other acute or chronic skin diseases present close to the lesion or the scalp donor area; 6. Patients with infectious diseases such as HBV, HCV, AIDS, syphilis, tuberculosis; 7. Patients with serious primary heart, liver, lung, kidney, blood disease, diabetes, thyroid disease or patients with a history of serious diseases affecting their survival, such as cancer or patients undergoing radiotherapy, chemotherapy, or immunotherapy; 8. Patients with long-term using of anticoagulant drugs; 9. Patients who are not fully informed consent due to mental and behavioral disorders; 10. Patients who received topical drugs for treating vitiligo in the last two weeks; 11. Patients who received systematic drugs or phototherapy for treating vitiligo in the last four weeks; 12. Patients who are allergic to dialysis membrane and lidocaine; 13. Patients having a uncertain or certain history of alcohol or drug abuse; 14. Patients with other lesions that complicate the enrollment or reduce the likelihood of enrollment, as judged by the researchers. For instance, frequent changes of work locations may easily cause loss of follow-up; 15. Patients who have participated in or are participating in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
Vesta;

Secondary

MeasureTime frame
improvement rate of melanin index;improvement rate of skin CT gray value;

Countries

China

Contacts

Public ContactXiang Leihong

Huashan Hospital, Fudan University

flora_xiang@vip.163.com+86 13818252671

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026