sensitive skin
Conditions
Interventions
Apply the test material to the lower leg once a day for 2 weeks.
Sponsors
LION CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Subject is male or female of any ethnicity between 21 to 59 years of age; b) Subject has a Fitzpatrick Skin Type I-IV Subject has self-perceived sensitive skin; d) Subject must feel mild to moderate itch on lower legs due to dryness at least once daily and must feel itch at the time of the first visit/screening and the baseline visit; e) Subject has mild to moderate dryness and redness on lower legs; f) Subject agrees not to shave/wax/remove hair on the lower legs for the conditioning phase and for the duration of the study once enrolled; g) Subject agrees not to wash or wet the test sites after test material application at the Baseline visit until completion of the 24 Hour visit; h) Subject is willing to refrain from the use of washcloths, loofahs, or coarse sponges on lower legs; i) Subject is willing to refrain from tanning and swimming for the duration of the study; j) Subject agrees not to start a new exercise program for the duration of the study; k) Subject agrees to wear clothing that easily allows access to the lower legs at all study visits in order to not rub the lower legs when rolling up the pants; l) Subject agrees not to wear pantyhose at any study visits; m) If subject uses OTC itch relievers, they agree to discontinue use on the lower legs but may continue use on other parts of the body; n) Subject agrees not to introduce any new cosmetic or toiletry products during the study; o) Subject is dependable and able to follow directions as outlined in the protocol; p) Subject is willing to participate in all study evaluations; q) Subject is in generally good health r) Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study; s) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; t) Subjects understands and is willing to sign an Informed Consent Form in conformance with 21 CRF Part 50:
Exclusion criteria
Exclusion criteria: a) Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control; b) Subject experiences repeated scratching that may cause raised areas on the skin which may bleed or become inflected due to the intense nature of the itch; c) Subject has hives; d) Subject has dense hair on the lower legs; e) Subject is a regular user of prescription itch relievers; f) Subject has used cosmetic itch relievers on the lower legs within one week prior to study start date; #VALUE! h) Subject has known allergies to cosmetics or toiletry products; i) Subject exhibits sunburn, rashes, scratches, burn marks, etc. on the test sites, or has tattoos or piercings which might interfere with study evaluations; j) Subject exhibits or reports a history of acute or chronic dermatological, medical, and/or physical conditions that would preclude application of the test material and/or could influence the outcome of the study; k) Subject has participated in a clinical study which involved the legs within one week of study initiation; l) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind; m) Subject has diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of itch(VAS method), stratum corneum water content, redness(dermatological assessment) before the application of the test material and after the application of test material for 1 and 2 weeks. | — |
Countries
North America
Contacts
Public ContactAKINORI INOUE
LION CORPORATION Global Development Center
Outcome results
None listed