Exploratory study on the effect of continuous application of cosmetics on skin barrier function and safety in healthy adults with a atopic background
- Conditions
- Healthy person
- Registration Number
- JPRN-UMIN000049818
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 25
Not provided
1 Person with symptoms of atopic dermatitis (Judged by skin findings, blood TARC level, and nonspecific IgE level) 2 Person who are at risk of developing symptoms of seasonal hay fever during the study period 3 Person with a history of serious diseases of the glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system, or psychiatric disorders 4 Person with a history of hypersensitivity to cosmetics or who may exhibit allergic symptoms 5 Person with a history of allergy to adhesive tape, medical tape, or rubber 6 Person who smokes habitually 7 Person with past surgical history on test site (forearm) 8 Persons with body hair that may interfere with the evaluation at the test site (forearm application site) 9 Person who has excessive sunburn on the test site at the time of obtaining consent 10 Person who shaves, epilates, or removes hair from the study site (forearm application site) during the study period 11 Person who had cosmetic procedures or treatments (e.g. peeling or laser treatment) on the test site (forearm application site) 12 Person who works night shifts and day/night shifts 13 Person with a history of alcohol and drug dependence 14 Person who is undergoing treatment (hormone replacement therapy, medication, exercise therapy, diet therapy, etc.) at a medical institution for the treatment or prevention of disease, or who are judged to be in need of such treatment at the time of obtaining consent 15 Breastfeeding, pregnant, with likelihood for pregnancy, planning for pregnancy 16 Person who has participated in any other clinical study (any study for using cosmetics, foods, drugs, medical devices, etc.) within the past 4 weeks, or who is scheduled to participate in any other clinical study during the scheduled period of this study. 17 Person who is judged to be inappropriate by investigator and subinvestigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transepidermal water loss Water content in stratum corneum Amino acid content in stratum corneum Filaggrin content in stratum corneum
- Secondary Outcome Measures
Name Time Method