Microneedling for Androgenic Alopecia: a Clinical Study
ConditionAndrogenic Alopecia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorTaipei Medical University WanFang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥22 years
Mild to moderate androgenic alopecia (for males, Norwood's grading II-IV, and for females, Ludwig stage I-II.)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Microneedling monotherapy without drugs
DeviceWe use microneedling without application of drugs to participants.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Microneeding to half of the scalp every two weeks with a total of 6 treatments.Experimental treatment 1 intervention
Group B: No treatment to half of the scalp during the trial.No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Follicular density
The number of hair follicles per cm²
Time frame
At baseline and at weeks 4, 8, 12, and 24 after trial initiation.2
Hair density
The number of hair shafts per cm²
Time frame
At baseline and at weeks 4, 8, 12, and 24 after trial initiation.3
Hair thickness
Average hair thickness (µm) in 1 cm²
Time frame
At baseline and at weeks 4, 8, 12, and 24 after trial initiation.4
Vellus-to-terminal hair ratio
The total number of vellus hairs divided by the total number of terminal hairs in 1 cm²
Time frame
At baseline and at weeks 4, 8, 12, and 24 after trial initiation.Secondary outcomes
1
Physician Global Assessment scale
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.
Time frame
At Weeks 12 and 24 after the initiation of the trial.2
Patient Global Assessment scale
On a scale of 0 to 10, 0: no improved, 5: moderately improved 10: fully improved.
Time frame
At Weeks 12 and 24 after the initiation of the trial.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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