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Prospective, Multicenter, Self-Controlled Clinical Trial Protocol to Evaluate the Safety and Efficacy of a Hair Follicle Transplantation Control System for Androgenetic Alopecia Patients

Prospective, Multicenter, Self-Controlled Clinical Trial Protocol to Evaluate the Safety and Efficacy of a Hair Follicle Transplantation Control System for Androgenetic Alopecia Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128733
Enrollment
Unknown
Registered
2026-07-24
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients with androgenetic alopecia and black or brown straight hair

Interventions

Control group:Conventional Manual FUE Method (Control Group)
Treatment group:Hair Follicle Transplantation Control System (Treatment Group Model: FT-002C)

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed with androgenetic alopecia, with BASP classification of M1-M3, C1-C3, U1-U3; 2. Aged 18 years or older, no restriction on gender; 3. Hair color is black or brown; 4. Straight hair; 5. Agree to trim the hair in the designated study area (trimmed to 0.7–1.2 mm); 6. Agree to retain 8 tattooed marking points in the designated study area; 7. After being fully informed of the trial details, the subject voluntarily participates in the trial, signs the informed consent form, and agrees to receive relevant examinations and clinical follow-ups;

Exclusion criteria

Exclusion criteria: 1. Subjects with hair color other than black or brown, or predominantly gray or white hair; 2. Subjects with a prior history of hair transplantation surgery; 3. Subjects with systemic illnesses unable to tolerate surgery; 4. Subjects with malignant tumors or infections at the donor or recipient site; 5. Patients with other obvious scalp diseases who are assessed as unfit for surgery; 6. Subjects with coagulation disorders, autoimmune diseases, or those taking oral immunosuppressants; 7. Subjects who have taken medications affecting blood coagulation function within 2 weeks; 8. Subjects suffering from severe mental and psychological disorders; 9. Subjects with keloid predisposition; 10. Pregnant women, breastfeeding women, and women planning to conceive within the next six months; 11. Subjects planning to participate in other clinical trials within the next month; 12. Subjects who have participated in other clinical trials within the past 3 months; 13. Other subjects deemed ineligible for enrollment by the investigator;

Design outcomes

Primary

MeasureTime frame
Follicle survival rate;

Secondary

MeasureTime frame
Physician satisfaction;Hair follicle transection rate;Subject satisfaction;Follicle discard rate;Physical Labor Saving Score;

Countries

China

Contacts

Public ContactWenyu Wu

Huashan Hospital, Fudan University

william88888@139.com+86 21 61578275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026