Microneedling for Androgenic Alopecia: a Clinical Study

Taipei Medical University

Status

Not yet enrolling

Conditions

Androgenic Alopecia

Treatments

Device: Microneedling monotherapy without drugs

Study type

Interventional

Funder types

Other

Identifiers

NCT07580521

N202509087

Details and patient eligibility

About

A total of 20-30 patients with mild to moderate androgenic alopecia are expected to be enrolled. Inclusion criteria are patients aged ≥22 years; for males, Norwood's grading II-IV, and for females, Ludwig stage I-II. After enrollment, one researcher will use computer-generated randomization to assign each side of the patient's scalp to either the experimental group or the control group. The scalp side allocated to the experimental group will receive microneedling treatment once every two weeks (at baseline, and at weeks 2, 4, 6, 8, and 10; six sessions in total). The control side of the scalp will not receive microneedling or any topical treatment.

Treatment efficacy will be evaluated at baseline and at weeks 4, 8, 12, and 24 after trial initiation. Evaluation methods include trichoscopy and standardized photography. Photographs will be reviewed by assessing physicians to determine follicular density, hair density, hair thickness, the ratio of vellus to terminal hairs, and physician global assessment. The evaluating physicians will be blinded to which side is the experimental group and which side is the control group.

At Weeks 12 and 24 after the initiation of the study, the evaluating physician will perform the Physician Global Assessment (PGA) scale based on the captured photographs. In addition, patient satisfaction with the treatment will be assessed through physician-administered interviews using the Patient Global Assessment scale.

Enrollment

25 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged ≥22 years
Mild to moderate androgenic alopecia (for males, Norwood's grading II-IV, and for females, Ludwig stage I-II.)

Exclusion criteria

Presence of obvious scalp wounds or other dermatologic lesions, including papulopustular rosacea, stage III-IV acne, eczema, herpes simplex, warts, scleroderma, bacterial or fungal infections, open wounds, actinic keratosis, or skin cancer
Alopecia other than androgenetic alopecia
Unilateral or uneven hair loss
History of keloid formation or keloid tendency
Pregnant women
Patients with HIV infection
Coagulation abnormalities (international normalized ratio [INR] > 1.2, activated partial thromboplastin time [aPTT] > 40 seconds), thrombocytopenia (< 100,000/μL), hemophilia, or current use of antiplatelet or anticoagulant medications
Patients with hepatitis B, hepatitis C, acquired immunodeficiency, or cancer
Patients using a cardiac pacemaker or other similar implantable medical devices
Patients using extracorporeal membrane oxygenation (ECMO) or other types of life-support equipment
Patients using medical devices with electrocardiographic monitoring functions