P193-23 (b) ADV FACIAL REGIMEN FOR WOMEN AGES 18 TO 70

NOTES:

• Subject must have self-perceived sensitive skin.
• Subject must agree to avoid sunbathing and/or excessive sun exposure.
• Subject must not have any known allergies to skin or eye treatment products or cosmetics, toiletries, and/or topical drugs.
• No other face or eye studies while on this study.
• Children are not allowed in the facility for visits longer than 20 minutes.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours: 7:30 a.m. to 5:00 p.m.

GROUP 1:
Visit 1:  Baseline  – Friday, 6/9 – 20 minutes
Visit 2:  Week 1 – Friday, 6/16 – 20 minutes
Visit 3:  Final – Friday, 7/7 – 20 minutes

GROUP 2:
Visit 1:  Baseline  – Monday, 6/19 – 20 minutes
Visit 2:  Week 1 – Monday, 6/26 – 20 minutes
Visit 3:  Final – Monday, 7/17 – 20 minutes

GROUP 3:
Visit 1:  Baseline  – Wednesday, 6/28 – 20 minutes
Visit 2:  Week 1 – Wednesday, 7/5 – 20 minutes
Visit 3:  Final – Wednesday, 7/26 – 20 minutes

GROUP 4:
Visit 1:  Baseline  – Thursday, 7/6 – 20 minutes
Visit 2:  Week 1 – Thursday, 7/13 – 20 minutes
Visit 3:  Final – Thursday, 8/3 – 20 minutes

Inclusion Criteria:
a) Subject is female, ages 18-70.
b) Subject has self-perceived sensitive skin (approximately 100% of the study population).
c) Subject has normal skin (approximately 25% of the study population), or oily skin (approximately 25% of the study population), or dry skin (approximately 25% of the study population), or combination skin (approximately 25% of the study population).
d) Subject exhibits no edema, no greater than barely perceptible (±) erythema, and no greater than slight (1) dryness of the test sites at baseline.
e) Subject agrees not to introduce any new cosmetic or toiletry products during the study.
f) Subject agrees to avoid sunbathing and/or excessive sun exposure.
g) Subject is dependable and able to follow directions as outlined in the protocol.
h) Subject is willing to participate in all study evaluations.
i) Subject is in generally good health and has a current Panelist Profile Form on file at ECRL.
j) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164.
k) Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”

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.