Microneedling for Androgenic Alopecia: a Clinical Study

NCT07580521 | Not Yet Recruiting FDA Device

• 1 other identifier: N202509087
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Androgenic Alopecia

Keywords

androgenic alopecia; microneedling

Outcome Measures

Primary Outcomes (4)

• Follicular density

  The number of hair follicles per cm²

  At baseline and at weeks 4, 8, 12, and 24 after trial initiation.

• Hair density

  The number of hair shafts per cm²

  At baseline and at weeks 4, 8, 12, and 24 after trial initiation.

• Hair thickness

  Average hair thickness (µm) in 1 cm²

  At baseline and at weeks 4, 8, 12, and 24 after trial initiation.

• Vellus-to-terminal hair ratio

  The total number of vellus hairs divided by the total number of terminal hairs in 1 cm²

  At baseline and at weeks 4, 8, 12, and 24 after trial initiation.

Secondary Outcomes (2)

• Physician Global Assessment scale

  At Weeks 12 and 24 after the initiation of the trial.

• Patient Global Assessment scale

  At Weeks 12 and 24 after the initiation of the trial.

Study Arms (2)

Microneeding to half of the scalp every two weeks with a total of 6 treatments.

EXPERIMENTAL

Device: Microneedling monotherapy without drugs

No treatment to half of the scalp during the trial.

NO INTERVENTION

Interventions

Microneedling monotherapy without drugs DEVICE

We use microneedling without application of drugs to participants.

Microneeding to half of the scalp every two weeks with a total of 6 treatments.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

MeSH Terms

Conditions

Alopecia

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-04