two-six years old children
Conditions
Interventions
Use the test product at least 4 times a day for 4 weeks.
Sponsors
Sunstar Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Infants with no symptoms of severe inflammation, eczema, atopic dermatitis, etc. at the test site. (2) The child's guardian agrees to participate in the test. (3) The child's guardian must be able to fill out usage diaries and questionnaires. (4) Must be able to come to the clinic on the designated date of visit.
Exclusion criteria
Exclusion criteria: (1) Those who have a history of allergies to pharmaceuticals, quasi-drugs, or cosmetics, or those who have skin hypersensitivity. (2) Those who have allergic symptoms to the ingredients of the test product. (3) Subjects who are taking drugs that may affect the evaluation of this study, such as steroids and immunosuppressants. (4) Subjects using topical steroids or Protopic on the test site. (5) Subjects who are using pharmaceuticals, quasi-drugs, and cosmetic hand care external preparations that may affect the usefulness of the test product. However, only petroleum jelly can be used. (6) Those who are participating in other clinical studies at the start of this study, or those who plan to participate in other clinical studies during the study period. (7) Those who are judged to be inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After using the test product for 4 weeks, "erythema", "scaling/desquamation", "dryness", "hardening/keratinization", "cracks", "disappearance of skin markings", and "pruritus" on palms, backs of hands and fingers. is visually evaluated by a dermatologist to determine safety and usefulness. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of skin hydration and transepidermal water loss, stratum corneum evaluation. | — |
Countries
Japan
Contacts
Public ContactTomomi Ayasu
Sunstar Inc. Health & Beauty Innovation R&D
Outcome results
None listed