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Exploratory Clinical Trial of Low Frequency Therapy for Skin Diseases

Exploratory Clinical Trial of Low Frequency Therapy for Skin Diseases

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1012240071
Enrollment
30
Registered
2025-02-18
Start date
2025-02-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo or alopecia areata Vitiligo, alopecia areata

Interventions

Treatment is performed with a low-frequency therapy device (JMDN code: 35372000, https://www.std.pmda.go.jp/scripts/stdDB/JMDN/stdDB_jmdn_resr.cgi?Sig=1&Select=1&jmdn_no= 2867&kjn_no=10123). Bathing s

Sponsors

Ujiie Hideyuki
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are eligible (i) Patients who are at least 18 years of age at the time of consent. (ii) Patients who have been diagnosed with vitiligo or alopecia areata based on clinical symptoms or pathological examination. (iii) Patients who, after receiving sufficient explanation of their participation in this study, are able to actively understand the consent document on their own initiative and have given their free written consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria Patients with any one of the following conditions shall be excluded from the study (1) Patients with a history of unstable vascular or neoplastic brain lesions (2) Patients receiving concomitant vagus nerve stimulation therapy (3) Patients with a history of severe cardiovascular disease (i4) Pregnant or lactating (5) Patients with skin hypersensitivity and a history of skin symptoms caused by metal or other substances. Translated with DeepL.com (free version)

Design outcomes

Primary

MeasureTime frame
Change in symptom severity rating scale (VASI score for vitiligo and SALT score for alopecia areata)) from study entry point to 52 weeks post-treatment

Secondary

MeasureTime frame
(i) Whether or not any adverse events occurred during infrasound therapy. (ii) DLQI scores before and after infrasound therapy (iii) The localization of immune cells before and after the infrasound treatment, the positive expression of molecules induced by inflammation, the intensity of expression, and the presence or absence of disease-related gene variants and their association with the pathological condition. Correlation between the state of inflammation and the expression status of clinicopathological factors and other analyzed molecules.

Contacts

Public ContactYuichi Kojima

Hokkaido University

yu1.kojima@pop.med.hokudai.ac.jp+81-117161161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026