Microneedling for Androgenic Alopecia: a Clinical Study

Официальное название

Microneedling for Androgenic Alopecia: A Clinical Study

Обзор

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.

Вмешательства

• Устройство Microneedling monotherapy without drugs
  We use microneedling without application of drugs to participants.

Первичные конечные точки

• Follicular density [Срок оценки: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.]
• Hair density [Срок оценки: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.]
• Hair thickness [Срок оценки: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.]
• Vellus-to-terminal hair ratio [Срок оценки: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.]

Вторичные конечные точки (2)

• Physician Global Assessment scale [Срок оценки: At Weeks 12 and 24 after the initiation of the trial.]
• Patient Global Assessment scale [Срок оценки: At Weeks 12 and 24 after the initiation of the trial.]

Критерии участия

Критерии включения

• Patients aged ≥22 years
• Mild to moderate androgenic alopecia (for males, Norwood's grading II-IV, and for females, Ludwig stage I-II.)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07580521 · N202509087

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗