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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneeding to half of the scalp every two weeks with a total of 6 treatments. | Experimental |
| |
| No treatment to half of the scalp during the trial. | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedling monotherapy without drugs | Device | We use microneedling without application of drugs to participants. |
|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Assessment scale | On a scale of 0 to 6, 0: total clearance [100% improvement]
| At Weeks 12 and 24 after the initiation of the trial. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |