NIPH Clinical Trials Search

JRCT ID: jRCTs051200136

Registered date:16/02/2021

Preventive effects of topical washing with miconazole nitratecontaining soap to diaper candidiasis

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studieddiaper candidiasis
Date of first enrollment15/06/2021
Target sample size76
Countries of recruitment
Study typeInterventional
Intervention(s)Placebo-controlled, double-blind, prospective study


Primary OutcomeConfirmation of Candida pseudohyphae by direct microscopic examination, and fungal culture
Secondary Outcomesafety

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
Include criteria1) Those who have obtained written consent for participation in the research 2) Home-visit nursing station users 3) Those who use diapers for daily excretion care 4) Those who need genital cleansing by a caregiver
Exclude criteria1) Those who need to apply corticosteroid hormones or antifungal agents externally to the cleaning site (buttocks, genital area, etc.), and have already applied externally 2) Those who are scheduled to see a dermatologist or receive topical treatment due to candidiasis during the test period. 3) Those who are already using soap that contains the same ingredients as the test soap (antifungal ingredients such as miconazole nitrate) 4) Persons who have high severity of skin symptoms at the site of cleaning and who have pain and need immediate drug treatment 5) Persons with a history of hypersensitivity to the test soap and its ingredients 6) Those who the principal investigator has determined to be inappropriate for inclusion in the research

Related Information


Public contact
Name Hidenori Takahashi
Address 2-6-21 Nagayamacho, Katsuyama, Fukui, Japan Fukui Japan 911-8558
Telephone +81-779-88-0350
Affiliation JCHO Fukui Katsuyama General Hospital
Scientific contact
Name Minoru Hasegawa
Address 23-3 Matsuoka-Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui, Japan Fukui Japan 910-1193
Telephone +81-776-61-3111
Affiliation University of Fukui Hospital