sensitive skin
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 is male or female between 21 to 59 years of age (age and sex to be captured in the demographics); b) A subject exhibits no edema at baseline; c) Subject agrees not to introduce any new cosmetic or toiletry products during the study; d) Subject agrees not to use any itch relief products on the arms and legs for the duration of the study; e) Subject identifies as having self-perceived eczema prone skin; f) Subject has at least one of three conditions: significantly dry skin at a test site (2: mild to 3: moderate dry skin as determined by a board certified dermatologist), history of eczema, or history of atopic diathesis (skin condition and test site where skin condition is observed to be captured in the demographics); g) Subject agrees to refrain from tanning and swimming for the duration of the study; h) Subject agrees not to start a new exercise program for the duration of the study; i) Subject is dependable and able to follow directions as outlined in the protocol and usage instructions provided by the Sponsor; j) Subject is willing to participate in all study evaluations; k) Subject is in generally good health and has a current Panelist Profile Form on file at ECRL; l) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; m) Subjects understands and is willing to sign an Informed Consent Form in conformance with 21 CRF Part 50: "Protection of Human Subjects."
Exclusion criteria
Exclusion criteria: a) Female subject (if applicable) is pregnant, nursing, planning a pregnancy, or not using adequate birth control; b) 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; c) Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would preclude application of the test material and/or could influence the outcome of the study; d) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study; e) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs; f) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind; g) 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