Microneedling for Androgenic Alopecia: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥22 years
- •Mild to moderate androgenic alopecia (for males, Norwood's grading II-IV, and for females, Ludwig stage I-II.)
排除标准
- •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
研究组 & 干预措施
Microneeding to half of the scalp every two weeks with a total of 6 treatments.
干预措施: Microneedling monotherapy without drugs (Device)
