Microneedling for Androgenic Alopecia: a Clinical Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microneedling monotherapy without drugs.
- Who it may be relevant to
- Registry conditions: Androgenic Alopecia. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Microneedling for Androgenic Alopecia: A Clinical Study
Overview
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.
Interventions
- Device Microneedling monotherapy without drugs
We use microneedling without application of drugs to participants.
Primary outcome measures
- Follicular density [Time frame: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.]
- Hair density [Time frame: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.]
- Hair thickness [Time frame: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.]
- Vellus-to-terminal hair ratio [Time frame: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.]
Secondary outcome measures (2)
- Physician Global Assessment scale [Time frame: At Weeks 12 and 24 after the initiation of the trial.]
- Patient Global Assessment scale [Time frame: At Weeks 12 and 24 after the initiation of the trial.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07580521 · N202509087