Exploratory Clinical Trial of Low Frequency Therapy for Skin Diseases

JRCT ID: jRCT1012240071

Registered date:18/02/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Vitiligo or alopecia areata
• Date of first enrollment: 18/02/2025
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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 should be avoided during stimulation, and the patient should be allowed to walk and move around, but only to the extent that the electrodes are not displaced.

Outcome(s)

• Primary Outcome: 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 Outcome

(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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include 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.

Exclude 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)

Related Information

• Primary Sponsor: Ujiie Hideyuki