P133 BIO PORE STUDY FOR WOMEN


P133 BIO PORE STUDY FOR WOMEN
Posted  May 24, 2021

START DATE06/28/2021
QUALIFICATIONSAfrican American Women Ages 18 to 35 & Ages 55 to 70
FITZPATRICK TYPES4 5 6 
TIME REQUIREMENT2 Visits: V1: 3 hours; V2: 45 minutes
COMPENSATION$200

NOTES:
This study would like to recruit a few Mother/Daughter pairs. Mother/Daughter pairs that complete the study will be entered into a raffle to win a prize. Mother and Daughter do not have to be on the same group.

* 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 Hours: 8:30 a.m. to 3 p.m.
Note: Group 1 (6/28, 6/29), Group 2 (6/29, 6/30), Group 3 (6/30, 7/1) & Group 4 (7/6, 7/7) are Alternates Only

Group 5:
Visit 1: Wednesday, 7/7 – 3 hours
Visit 2: Thursday, 7/8 – 45 minutes

Group 6:
Visit 1: Monday, 7/19 – 3 hours
Visit 2: Monday, 7/20 – 45 minutes

Group 7:
Visit 1: Tuesday, 7/20 – 3 hours
Visit 2: Wednesday, 7/21 – 45 minutes

Group 8:
Visit 1: Wednesday, 7/21 – 3 hours
Visit 2: Thursday, 7/22 – 45 minutes

Group 9:
Visit 1: Monday, 7/26 – 3 hours
Visit 2: Tuesday, 7/27 – 45 minutes

Group 10:
Visit 1: Tuesday, 7/27 – 3 hours
Visit 2: Wednesday, 7/28 – 45 minutes

Additional Groups are available.

Inclusion Criteria:
A subject may be eligible for study participation if all of the following criteria are met:
a) Subject is female between 18-35 (approximately 50%) or 55-70 (approximately 50%) years of age;
b) Subject has Fitzpatrick skin type IV-VI;
c) Subject is 100% African American ethnicity;
d) Subject has medium to large pores on their face (score between 4-9 according to the scale listed in section 7.9);
e) Subjects 55-70 years old have age spots on the face (solar lentigines or hyperpigmentation) (approximately 20 subjects);
f) Subjects 18-35 years old have acne lesions on the face (inflamed/non-inflamed or PIH) (approximately 20 subjects);
g) Subject agrees to use the provided non-moisturizing soap for the face at their baseline visit;
h) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
i) Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
j) Subject agrees to avoid sun tanning or extreme exposure under sun at least one week before the start of the study;
k) Subject agrees to not use sunscreen products starting two days before the study visits;
l) Subject is willing to participate in all study evaluations;
m) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
n) Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
o) Subject has completed a HIPAA Authorization Form in conformance with
45 CFR Parts 160 and 164;
p) Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects”;
q) Subject is willing to follow the social distancing rules and all COVID-19 safety precaution;
r) Subject is willing to remove mask for all study evaluations and laboratory acclimations;
s) Subject agrees to refrain from additional skin treatments on face for duration of the study;
t) Subject is not currently participating and will not participate in any other study involving the test area (face) for the duration of the study.

Exclusion:
a) Subject 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 two weeks prior to initiation of the study;
c) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
d) Subject exhibits any rashes, scratches, or burn marks on the test site (face);
e) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
f) Subject has diabetes.
g) Subject routinely or has recently used medications which may interfere with testing (e.g. insulin, steroids, steroid anti-inflammatories, Singulair, inhalers more than 3x a month, or immunosuppresants);
h) Subject has used or is currently using Isotretinoin (Accutane), Retin-A, Retinol, or AHAs on face in the past 2 months,
i) Subject reports a history of allergies to latex gloves or tape adhesives;
j) Subject has had cosmetic medical procedures on the face such as injectable anti-wrinkle products, cosmetic surgery, tattoo removal, home light facial procedures, or home use medical devices, etc. within the past year;
k) 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;
l) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study or has self-reported testing positive for COVID-19 during the study;
m) Subject is currently using or having regularly used corticosteroids (systemic or topical, not nasal or ocular) within the past 4 weeks (including but not limited to betamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, halcinonide, and halobetasol), or lipid/cholesterol-lowering medication (e.g. fat intake inhibitor).


Fitzpatrick Scale

Fitzpatrick Scale



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