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Clinical Study on the Safety and Efficacy of the FT-002B Hair Follicle Extraction Device for Androgenetic Alopecia Patients?

Clinical Study on the Safety and Efficacy of the FT-002B Hair Follicle Extraction Device for Androgenetic Alopecia Patients?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101631
Enrollment
Unknown
Registered
2025-04-27
Start date
2025-05-12
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Androgenetic alopecia

Interventions

Control group:Manual extraction
Experimental group:Folliclar Unit Transplant Equipment FT-002B

Sponsors

Jing'an District Central Hospital Of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1) Clinically confirmed androgenetic alopecia, Hamilton-Norwood grade II.-VI. in male patients and BASP grade (type M, M1-M3) in female patients; 2) Age 18-59 years old, male or female; 3) The hair color is black or brown; 4) Straight hair; 5) agree to trim the hair in the designated study area (trimmed to 1.0-1.5mm); 6) Agree to leave 8 striated marking points in the designated study area; 7) After being fully informed about the trial, voluntarily participate in and sign the "Informed Consent Form".

Exclusion criteria

Exclusion criteria: 1) The hair color is other than black and brown, or mainly gray or white hair. 2) Patients who have had previous hair transplant surgery; 3) Patients with systemic diseases who cannot tolerate surgery; 4) Malignant tumors and infections in the donor area; 5) Those with other obvious scalp diseases who are not suitable for surgery after evaluation; 6) Coagulation mechanism disorders, autoimmune diseases and oral immunosuppressants; 7) Those who use drugs that affect coagulation function within 2 weeks; 8) Those suffering from severe mental and mental illness; 9) Patients with scar constitution; 10) Pregnant and lactating women; 11) Those who have participated in other clinical trials in the past 6 months; 12) Other patients who are judged by the investigator to be ineligible for inclusion.

Design outcomes

Primary

MeasureTime frame
follicle transection rate;

Secondary

MeasureTime frame
Hair follicle viability;Security evaluation indicators;follicular unit discard rate;

Countries

China

Contacts

Public ContactWu Wenyu

Shanghai Jing'an District Central Hospital

william88888@139.com+86 21 61578275

Outcome results

None listed

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