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NCT Number: NCT07580521

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.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microneedling monotherapy without drugs

Device

We use microneedling without application of drugs to participants.

Primary outcomes

  1. Follicular density

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

    The number of hair follicles per cm²

  2. Hair density

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

    The number of hair shafts per cm²

  3. Hair thickness

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

    Average hair thickness (µm) in 1 cm²

  4. Vellus-to-terminal hair ratio

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

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

Secondary outcomes

  1. Physician Global Assessment scale

    Time frame: At Weeks 12 and 24 after the initiation of the trial.

    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.

  2. Patient Global Assessment scale

    Time frame: At Weeks 12 and 24 after the initiation of the trial.

    On a scale of 0 to 10, 0: no improved, 5: moderately improved 10: fully improved.

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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