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Cross-over comparative study of the skin microbiome for atopic dermatitis using soap SO-145

SO-145 on skin microbiome for atopic dermatitis

Kondo Yasuto

FUJITA HEALTH UNIVERSITY BANTANE HOSPITAL

3-6-10 Otobashi, Nakagawa-ku, Nagoya-City Aichi-Pref.

ykondo@fujita-hu.ac.jp

Kondo Yasuto

FUJITA HEALTH UNIVERCITY BANTANE HOSPITAL

3-6-10 Otobashi, Nakagawa-ku, Nagoya-City Aichi-Pref.

+81-52-321-8171

ykondo@fujita-hu.ac.jp

Recruiting

Oct. 14, 2022

Interventional

randomized controlled trial

double blind

placebo control

crossover assignment

prevention purpose

Among patients 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.

1. 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
6. Patients with positive milk-specific IgE

Both

atopic dermatitis

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.

atopic dermatitis

D003876

Percentage of Staphylococcus epidermidis 12 weeks after the start of use

1. 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 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

+81-562-93-2865

April. 06, 2022

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