NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000029756

Registered date:01/11/2018

A using test for four continuous weeks of skin care product against male atopic dermatitis patients

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMinor to mild whole face atopic dermatitis, according to the severity classification of rash in the atopic dermatitis guideline of Japanese Dermatological Association.
Date of first enrollment2017/11/02
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Inspection such as observation, measurement and questionnaire before test start - Apply the test sample on whole face, two times in a day, in the morning and the evening, for two weeks - Inspection such as observation, measurement and questionnaire, at two weeks after test start - Apply the test sample on whole face, two times in a day, in the morning and the evening, for two weeks - Inspection such as observation, measurement and questionnaire, at four weeks after test start

Outcome(s)

Primary OutcomeDoctor's findings such as dryness or scales, erythema, papules, scratch marks on the face.
Secondary OutcomeStratum corneum water content, transepidermal water transpiration amount, microscope photography, photography, questionnaire

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum49years-old
GenderMale
Include criteriaThose who satisfy all of the following conditions 1) Male aged 20 to 49. 2) Subjects who have minor to mild whole face atopic dermatitis, according to the severity classification of rash in the atopic dermatitis guideline of Japanese Dermatological Association. 3) Subjects who are using skin care product, such as facial wash, more than once in a day on their face in currently. 4) Subjects who show their willingness of participating to the test, and who obtain consent to participate in the test after understanding explanation of test.
Exclude criteria1) Subjects who have skin symptom such as moderate or higher atopic dermatitis, oral dermatitis, rosacea-like dermatitis. 2) Subjects who have trauma on the site of observation. 3) Subjects who have possibility to take a lot of sunlight such as daily sports at outside. 4) Subjects who have allergic symptoms against external medicine, cosmetic, quasi-drugs and others in the past. 5) Subjects who have severe hay fever. 6) Heavy alcohol drinker. 7) Subjects who have previous and/or current medical history of serious disease in liver, kidney, myocardial infarction. 8) Subjects who have severe anemia. 9) Subject who are going to hospital and being accepted medical treatment due to disease, except dentistry. 10) Persons who concern this test such as requester of this test and employee of trustee company. 11) Subjects who themselves and/or their family are working for a pharmaceutical companies and cosmetic companies. 12) Subjects who are participating in clinical tests, use tests and product monitor tests of medicines etc. And subjects who have been participated within 3 month in those tests described above. 13) Others who have been determined ineligible by investigator.

Related Information

Contact

public contact
Name Kazunori Takashima
Address 1-11-2 Ebisu Shibuya-ku, Tokyo 150-0013, JAPAN Japan
Telephone 03-5793-8712
E-mail takashima@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