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

UMIN ID: UMIN000029756

Registered date:01/11/2018

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Minor 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 enrollment: 2017/11/02
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• 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 Outcome: Doctor's findings such as dryness or scales, erythema, papules, scratch marks on the face.
• Secondary Outcome: Stratum corneum water content, transepidermal water transpiration amount, microscope photography, photography, questionnaire

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 49years-old
• Gender: Male
• Exclude criteria: 1) 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

• Primary Sponsor: Inforward, inc EBISU skin research center
• Source(s) of Monetary Support: DAIICHI SANKYO HEALTHCARE CO., LTD. R&D Department