P176 BIO BRIGHTENING FACE & BODY FOR MEN & WOMEN


P176 BIO BRIGHTENING FACE & BODY FOR MEN & WOMEN
Posted  June 10, 2021

START DATE07/06/2021
QUALIFICATIONSMen & Women Ages 30 to 65
FITZPATRICK TYPES1 2 3 4 
TIME REQUIREMENT12 Visits - 3 of the visits are on the same day
COMPENSATION$525

NOTES: PRESCREENING IS REQUIRED with a clean, make-up free face.
* Must have Normal to Dry Skin, No Sensitive Skin
* Must have mild to moderate fine lines and wrinkles, marionette lines, visible facial dark spots and uneven skintone.
* Cosmetic tattoos on face are okay. (eyeliner/eyebrows/lip liner)
* Males must be clean-shaven for all study visits.
* Visits 2, 3 and 4 of this study will take place on the same day: Visit 2 between 7 & 10 a.m., then 4 and 8 hours post product application.
* You must wear a face mask/covering while at ECRL except when requested to remove it for acclimation and photos.
* Children, purses or other personal bags are not permitted in the facility at this time.

Study Times:
Visit 1: Between 7:40 a.m. and 12 p.m.
Visit 2 will be scheduled between 7 a.m. and 10 a.m. with the Bio department. Visits 3 & 4 will take place on the same day at 4 and 8 hours post application.
Visits 5 will be 24 hours post application
Visits 6 – 12 will be the same time as Visit 1

Group 1:
Visit 1:  Tuesday, 7/6 – 45 minutes
Visit 2: Monday, 7/12 – 2.5 hours
Visit 3 & 4: Same day as Visit 2 – 4 and 8 hours post application – 1 hour each
Visit 5: Tuesday, 7/13 – 1.5 hours
Visit 6: Thursday, 7/15 – 1.5 hours
Visit 7: Wednesday – 7/21- 1.5 hours
Visit 8: Wednesday – 7/28 – 1.5 hours
Visit 9: Wednesday – 8/11 – 1.5 hours
Visit 10: Monday – 8/23 – 1.5 hours
Visit 11: Tuesday – 9/7 – 1.5 hours
Visit 12: Tuesday – 9/21 – 1.5 hours

Group 2:
Visit 1:  Tuesday, 7/6 – 45 minutes
Visit 2: Tuesday, 7/13 – 2.5 hours
Visit 3 & 4: Same day as Visit 2 – 4 and 8 hours post application – 1 hour each
Visit 5: Wednesday, 7/14 – 1.5 hours
Visit 6: Friday, 7/16 – 1.5 hours
Visit 7: Wednesday – 7/21- 1.5 hours
Visit 8: Wednesday – 7/28 – 1.5 hours
Visit 9: Wednesday – 8/11 – 1.5 hours
Visit 10: Monday – 8/23 – 1.5 hours
Visit 11: Tuesday – 9/7 – 1.5 hours
Visit 12: Tuesday – 9/21 – 1.5 hours

Group 3:
Visit 1:  Monday, 7/12 – 45 minutes
Visit 2: Monday, 7/19 – 2.5 hours
Visit 3 & 4: Same day as Visit 2 – 4 and 8 hours post application – 1 hour each
Visit 5: Tuesday, 7/20 – 1.5 hours
Visit 6: Thursday, 7/22 – 1.5 hours
Visit 7: Monday – 7/26- 1.5 hours
Visit 8: Wednesday – 8/4 – 1.5 hours
Visit 9: Monday – 8/16 – 1.5 hours
Visit 10: Monday – 8/30 – 1.5 hours
Visit 11: Monday – 9/13 – 1.5 hours
Visit 12: Monday – 9/27 – 1.5 hours

Group 4:
Visit 1:  Monday, 7/12 – 45 minutes
Visit 2: Tuesday, 7/20 – 2.5 hours
Visit 3 & 4: Same day as Visit 2 – 4 and 8 hours post application – 1 hour each
Visit 5: Wednesday, 7/21 – 1.5 hours
Visit 6: Friday, 7/23 – 1.5 hours
Visit 7: Monday – 7/26- 1.5 hours
Visit 8: Wednesday – 8/4 – 1.5 hours
Visit 9: Monday – 8/16 – 1.5 hours
Visit 10: Monday – 8/30 – 1.5 hours
Visit 11: Monday – 9/13 – 1.5 hours
Visit 12: Monday – 9/27 – 1.5 hours

Inclusion Criteria:
a) Subject is male (Approx. 25%) or female (Approx. 75%) of any ethnicity;
b) Subject is between 30 and 65 years of age;
c) Subject has Fitzpatrick skin type I-IV (up to 15% Fitzpatrick skin type IV);
d) Subject has self-perceived normal to dry skin type;
e) Subject has self-perceived normal skin (not sensitive);
f) Subject has mild to moderate fine line and wrinkles;
g) Subject has marionette lines;
h) Subject presents visible facial dark spots and uneven skintone;
i) Subject agrees to remove face mask for the acclimation period (within socially distanced proximity of other subjects) and for study evaluations (including image captures), and to replace the face mask as directed by study staff;
j) Subject agrees to refrain from drinking hot/caffeinated beverages 2 hours prior to each study visit;
k) Subject must have intact skin within the treatment sites;
l) Subject agrees to not wash or rinse the test material off of the test site(s) until after the 24 hour return visit;
m) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
n) Subject agrees to use the non-moisturizing soap during the conditioning phase and for the duration of the study;
o) Subject agrees not to shave or wax the test sites within 48 hours prior to the baseline visit and for 48 hours prior to any other study visits;
p) Subject agrees to wear loose clothing for easy access to the test sites (arms or legs) and wear pants and/or sleeves that can be easily rolled up;
q) Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
r) Subject is willing to participate in all study evaluations;
s) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
t) Subject agrees to sign a Photography Release Form for study evaluations and in the event of an adverse event, providing consent for use of photography in relation to this clinical study;
u) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
v) 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 is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject has self-perceived oily skin;
c) Subject is participating on another clinical study;
d) Subject exhibits irritation, excessive hair, tattoos, sunburn, rashes, scratches, burn marks, scarring, acne, etc. on the test sites, which might interfere with evaluation of test results;
e) 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;
f) 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;
g) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
h) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
i) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
j) Subject has diabetes.

 


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