Healthy person
Conditions
Interventions
The placebo emulsion is applied to one of the left and right forearms and the test emulsion to the other for 6 weeks.
The placebo emulsion is applied to one of the left and right forearms and the test
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: More than 20 years old and under 60 when obtaining consent Applicant must have been fully informed about the study, the person who has the ability to consent, understand the study well, and voluntarily agree to participate in the study in writing. Persons who has atopic background (history of atopic dermatitis or family history of atopic dermatitis) Persons who do not habitually apply prescription drugs to the test site (forearm) Persons who do not routinely clean test site (forearm) with a firm body-washing device (e.g. nylon towel or brush). Persons who are judged by the principal investigator to be safe to participate in the study based on the results of pre-application testing
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transepidermal water loss Water content in stratum corneum Amino acid content in stratum corneum Filaggrin content in stratum corneum | — |
Countries
Japan
Contacts
Public ContactAkihiro Aoki
Otsuka Pharmaceutical Co., Ltd. Otsu Skin Care Research Institute
Outcome results
None listed