NOTES:
- Subject agrees to avoid excessive sun exposure of the test sites and to refrain from visits to tanning salons during the course of this study.
- Subject agrees to refrain from getting patches wet, scrubbing or washing the test area with soap, and applying powders, lotions or personal care products to the area during the course of the study.
- Subject must not exhibit tattoos or any dermal markings on the back that might interfere with grading.
- Subject must have completed a 24-Hr Back Patch Study at least once before signing up for a Follicular Biopsy Study.
- No other studies for the back.
- Children are not allowed in the facility for visits longer than 20 minutes.
Study Hours: 7:30 A.M. TO 6:30 P.M.
Visits : 13 visits: 6/2, 6/5, 6/7, 6/9, 6/12, 6/14, 6/16, 6/19, 6/21, 6/23, 6/26, 6/28, 6/30 (M, W, F) – Approx. 10 minutes each visit. Last visit will last approx. 30 minutes and requires an appt. time.
Inclusion Criteria:
a) Subject is male or female between 18 and 55 years of age;
b) Subject does not exhibit any skin diseases or abnormalities which might be confused with a skin reaction from the test material;
c) Subject agrees to avoid excessive sun exposure of the test sites and to refrain from visits to tanning salons during the course of this study;
d) Subject agrees to refrain from getting patches wet, scrubbing or washing the test area with soap, and applying powders, lotions or personal care products to the area during the course of the study;
e) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
f) Subject is dependable and able to follow directions as outlined in the protocol;
g) Subject is willing to participate in all study evaluations;
h) Subject is in generally good health and has a current Panelist Profile Form and Medical History Form on file at CRL;
i) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
j) Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”
k) Subject has oily skin or has a history of acne vulgaris;
l) Subject exhibits large pores on the upper back.
Exclusion Criteria:
a) Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject is currently using systemic antibiotics and/or acne medications or topical acne medications on the test area (e.g. Clindamycin, Erythromycin, Tetracycline, Retin A, Accutane, benzoyl peroxide or salicylic acid products, or any OTC acne treatment medications);
c) 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;
d) Subject has a history of acute or chronic dermatologic (including active eczema or psoriasis on the test sites), medical, and/or physical conditions which would preclude application of the test material and/or could influence the outcome of the study;
e) Subject is under treatment for a skin and/or systemic bacterial infection;
f) Subject exhibits birthmarks, moles, vitiligo, keloids, or any dermal markings on the back that might interfere with grading;
g) Subject is an insulin-dependent diabetic;
h) Subject has a history of skin cancer or is currently undergoing treatment for active cancer of any type;
i) Subject reports a history of allergies to tape adhesives;
j) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
k) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
Fitzpatrick Scale
