NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041220073

Registered date:14/10/2022

SO-145 on skin microbiome for atopic dermatitis

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedatopic dermatitis
Date of first enrollment14/10/2022
Target sample size44
Countries of recruitment
Study typeInterventional
Intervention(s)After registration, the study subjects will receive skin care guidance and will be washed with soap once a day according to a certain method. Use SO-145 soap containing FSDG and placebo soap for 12 weeks each, and record changes in skincondition with a 12-week washout period after each soap.

Outcome(s)

Primary OutcomePercentage of Staphylococcus epidermidis 12 weeks after the start of use
Secondary Outcome1. Percentage of Staphylococcus epidermidis 4 and 12 weeks after the start of use and 4 weeks after the end of use 2. Percentage of Staphylococcus aureus 4 and 12weeks after the start of use and 4 weeks after the end of use (Measurement method: Sequence analysis of the bacterial flora on the cheeks of patients who have not used cosmetics for more than 7 hours after washing their face.) 3. Percentage of Staphylococcus aureus, TEWL, keratin water content, pH 4 and 12 weeks after the start of use and 4 weeks after the end of use (Use the TEWL, keratin water content, and pH measurement results of the patient's cheeks 7 hours or more after washing the face and without using cosmetics.) 4.Changes in serum TARC level, milk-specific IgE level, basophils, and amount of change in activation of effector cells 12 weeks after the start of use 5.Changes in bacterial flora diversity by skin bacterial flora sequence analysis 4 to 12 weeks after the start of use and 4 weeks after the end of use

Key inclusion & exclusion criteria

Age minimum>= 6age old
Age maximum<= 49age old
GenderBoth
Include criteriaAmong patients in their lower grades to 40s with mild atopic dermatitis 1. Patients who have received sufficient explanation before participating in this study, and who have obtained written consent at the discretion of the patient or their guardian with sufficient understanding. 2. Staphylococcus epidermidis and Staphylococcus aureus carriers in patients with mild or mild eruption who have been diagnosed with atopic dermatitis based on the definition and diagnostic criteria for atopic dermatitis.
Exclude criteria1. Adrenal steroids Taking steroids, intensifying the platinum immunomodulatory drug 2. Basic sterilization Illness Slightly preventive bactericidal drug is taken internally 3. Patients who are recommended to use topical steroids on the face 4. Patients who originally use FSDG for soap 5. Patients, researchers, research coordinators

Related Information

Contact

Public contact
Name Yasuto Kondo
Address 3-6-10 Otobashi, Nakagawa-ku, Nagoya-City Aichi-Pref. Aichi Japan 454-8509
Telephone +81-52-321-8171
E-mail ykondo@fujita-hu.ac.jp
Affiliation FUJITA HEALTH UNIVERCITY BANTANE HOSPITAL
Scientific contact
Name Yasuto Kondo
Address 3-6-10 Otobashi, Nakagawa-ku, Nagoya-City Aichi-Pref. Aichi Japan 454-8509
Telephone +81-52-321-8171
E-mail ykondo@fujita-hu.ac.jp
Affiliation FUJITA HEALTH UNIVERSITY BANTANE HOSPITAL