Androgenic Alopecia
Conditions
Keywords
androgenic alopecia, microneedling
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.
Interventions
DEVICEMicroneedling monotherapy without drugs
We use microneedling without application of drugs to participants.
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Follicular density | At baseline and at weeks 4, 8, 12, and 24 after trial initiation. | The number of hair follicles per cm² |
| Hair density | At baseline and at weeks 4, 8, 12, and 24 after trial initiation. | The number of hair shafts per cm² |
| Hair thickness | At baseline and at weeks 4, 8, 12, and 24 after trial initiation. | Average hair thickness (µm) in 1 cm² |
| Vellus-to-terminal hair ratio | 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
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment scale | At Weeks 12 and 24 after the initiation of the trial. | On a scale of 0 to 6, 0: total clearance \[100% improvement\] 1. almost total clearance \[90% improvement\] 2. distinct clearance \[75% improvement\] 3. moderate clearance \[50% improvement\] 4. mild clearance \[25% improvement\] 5. no change 6. worse. |
| Patient Global Assessment scale | 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. |
Countries
Taiwan
Outcome results
None listed