Microneedling for Androgenic Alopecia: a Clinical Study
Microneedling for Androgenic Alopecia: A Clinical Study
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Taipei, Taiwan
- Wang Fang Hospital
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Microneeding to half of the scalp every two weeks with a total of 6 treatments.
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We use microneedling without application of drugs to participants.
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Kein Eingriff: No treatment to half of the scalp during the trial.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Follicular density
Zeitfenster: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
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The number of hair follicles per cm²
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At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
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Hair density
Zeitfenster: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
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The number of hair shafts per cm²
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At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
|
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Hair thickness
Zeitfenster: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
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Average hair thickness (µm) in 1 cm²
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At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
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Vellus-to-terminal hair ratio
Zeitfenster: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
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The total number of vellus hairs divided by the total number of terminal hairs in 1 cm²
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At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Physician Global Assessment scale
Zeitfenster: At Weeks 12 and 24 after the initiation of the trial.
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On a scale of 0 to 6, 0: total clearance [100% improvement]
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At Weeks 12 and 24 after the initiation of the trial.
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Patient Global Assessment scale
Zeitfenster: At Weeks 12 and 24 after the initiation of the trial.
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On a scale of 0 to 10, 0: no improved, 5: moderately improved 10: fully improved.
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At Weeks 12 and 24 after the initiation of the trial.
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- N202509087
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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