NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000032333

Registered date:10/05/2019

A using test for four continuous weeks of SC1722 against babies

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNot applicable
Date of first enrollment2018/05/10
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Inspection before test start - Use the test sample on the whole body for two weeks - Inspection such as observation and measurement at two weeks after test start - Use the test sample on the whole body for two weeks - Inspection such as observation and measurement at four weeks after test start

Outcome(s)

Primary OutcomeDoctor's findings such as dryness or scales, erythema, papules, scratch marks on the whole body prior to starting test and at four weeks after test start.
Secondary Outcome*Doctor's findings such as dryness or scales, erythema, papules, scratch marks on the whole body prior to starting test and at two weeks after test start. *Measuring stratum corneum water content of skin, transepidermal water transpiration amount of skin prior to starting test and at two and four weeks after test start.

Key inclusion & exclusion criteria

Age minimum28days-old
Age maximum365days-old
GenderMale and Female
Include criteria
Exclude criteria1)Premature babies. 2)Subjects with birth weight >2,500g. 3)Subjects who have severe eczema infantile. 4)Subjects who have skin symptom such as atopic dermatitis. 5)Subjects who have trauma on the part that uses the test sample. 6)Subjects who have possibility to take a lot of sunlight. 7)Subjects who are participating in clinical tests and use tests that apply cosmetic, quasi-drugs and others. 8)Subjects who have allergic symptoms against external medicine, cosmetic, quasi-drugs and others in the past. 9)Subjects who have previous and/or current medical history of serious disease in liver, kidney, myocardial infarction. 10)Subject who are going to hospital and being accepted medical treatment due to disease. 11)Subjects who have their family that are working for cosmetic companies and pharmaceutical companies. 12)Others who have been determined ineligible by investigator.

Related Information

Contact

public contact
Name Kanako Sakurai
Address 1-11-2 Ebisu Shibuya-ku, Tokyo 150-0013, JAPAN Japan
Telephone 03-5793-8712
E-mail sakurai@inforward.co.jp
Affiliation Inforward, inc EBISU skin research center
scientific contact
Name Tomohiko Yamaguchi
Address 3-14-10 Nihonbashi Chuo-ku, Tokyo 103-8234, JAPAN Japan
Telephone 03-5255-6336
E-mail yamaguchi.tomohiko.m6@daiichisankyo-hc.co.jp
Affiliation DAIICHI SANKYO HEALTHCARE CO., LTD. R&D Department