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

JRCT ID: jRCTs051200136

Registered date:16/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: diaper candidiasis
• Date of first enrollment: 15/06/2021
• Target sample size: 76
• Study type: Interventional
• Intervention(s): Placebo-controlled, double-blind, prospective study

Outcome(s)

• Primary Outcome: Confirmation of Candida pseudohyphae by direct microscopic examination, and fungal culture
• Secondary Outcome: safety

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Hasegawa Minoru