Microneedling for Androgenic Alopecia: a Clinical Study

Microneedling for Androgenic Alopecia: A Clinical Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Device: Microneedling monotherapy without drugs

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microneeding to half of the scalp every two weeks with a total of 6 treatments.	Device: Microneedling monotherapy without drugs; We use microneedling without application of drugs to participants.
No Intervention: No treatment to half of the scalp during the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Global Assessment scale	On a scale of 0 to 6, 0: total clearance [100% improvement]; almost total clearance [90% improvement]; distinct clearance [75% improvement]; moderate clearance [50% improvement]; mild clearance [25% improvement]; no change; worse.	At Weeks 12 and 24 after the initiation of the trial.
Patient Global Assessment scale	On a scale of 0 to 10, 0: no improved, 5: moderately improved 10: fully improved.	At Weeks 12 and 24 after the initiation of the trial.

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: androgenic alopecia; microneedling
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Pharmaceutical Preparations; Investigative Techniques; Technology, Pharmaceutical; Dosage Forms
• Other Study ID Numbers: N202509087

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes