Health Female
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Female between the Age from 20<= <45 at the time of obtaining consent 2) Those who have the ability to consent, comply with matters to be complied with while participating in the examination, undergo the pre-examination stipulated in this test implementation plan, and can declare subjective symptoms, etc. 3) Those who do not have skin diseases such as dermatitis and eczema at the site where study drug will be administered 4) A person who has no history of rashes caused by bandages and contact dermatitis caused by metal, cosmetics, household products, etc. 5) Those who have a BMI (Body Mass Index) of 18.5 or more and 30.0 or less at the time of screening visit
Exclusion criteria
Exclusion criteria: ) Those who have a history of evaluation of this test and considered to have an impact on safety, such as Drug abuse/ dependence, alcohol abuse/ dependence, heart, liver, kidney, lung, eye, blood, digestive diseases, etc. 2) A person who has a history of allergies to drugs or has a specific constitution (Alcohol hypersensitivity, etc.) 3) Those who may use the drug (antihistamines, adrenal cortical hormone agents) within one week before administered the study drug 4) Pregnant or nursing women 5) Those who are within 3 months of participating in other clinical trials 6) In addition, those who are deemed unsuitable for this study by the physician responsible for the research or the doctor sharing the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of skin irritation based on the ICDRG (International Contact Dermatitis Research Group) Standards | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Evaluated for all adverse events | — |
Countries
Japan
Contacts
Showa University School of Medicine Department of Clinical Pharmacology