Healthy subjects
Conditions
Interventions
Apply the test material to inner forearms (right and left) and to shins (right and left) once a day for 4 weeks.
Sponsors
Lion Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Subject exhibits no edema, no greater than barely perceptible erythema, and no greater than slight (1) dryness of the test sites at baseline; b) Subject's parent/legal guardian agrees to refrain from applying any other products to the test sites, other than the provided test material, for the duration of the study; c) Subject's parent/legal guardian agrees not to introduce any new cosmetic or toiletry products during the study; d) Subject's parent/legal guardian is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits; e) Subject's parent/legal guardian allows the subject to participate in all study evaluations; f) Subject is in generally good health and has a current Panelist Profile Form on file at CRL; g) Subject's parent/legal guardian has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; h) Subject's parent/legal guardian understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Subjects."
Exclusion criteria
Exclusion criteria: a) Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study; b) Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study; c) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study; d) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs; e) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind; f) Subject has insulin-dependent diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermal evaluation by a dermatologist before and 4 weeks after use of a test material. | — |
Countries
North America
Contacts
Public ContactAKINORI INOUE
Lion Corporation Global Development Center
Outcome results
None listed