P216-22 ADV CLINIC FACIAL STING SCREENER / DERM UNDEREYE BRIGHTENER STUDY FOR WOMEN


P216-22 ADV CLINIC FACIAL STING SCREENER / DERM UNDEREYE BRIGHTENER STUDY FOR WOMEN
Posted  June 1, 2022

START DATE06/28/2022
QUALIFICATIONSAll Women Ages 18 to 75
TIME REQUIREMENT3 Visits, 20 minutes each
COMPENSATION$60

NOTES:  The first visit on this study is a screening visit. Panelists who fail the screen will receive $25 for the visit.

  • No other studies for the Face and Eyes.
  • Subject must be screened before being enrolled in the study.  Panelist must be Lactic Acid sensitive.
  • Masks are optional while at Eurofins|CRL.  If you wear a mask, you must be willing to remove it when requested by ECRL staff for study evaluations & photos.

Please read all Inclusion & Exclusion criteria below.

Screening Study Hours: 8:30 a.m. to 4:30 p.m. – 20 minutes
Screening dates (Panelist will be scheduled for one date):  6/28, 6/29, or 6/30

Study Hours:  8:30 a.m. to 5 p.m.

Visit 1: Baseline – Wednesday, 7/6 – 20 minutes
Visit 2: Final – Wednesday, 8/3 – 20 minutes

Inclusion Criteria:
a. Subject is female between 18 and 75 years of age.
b. Subject is a 100% Lactic Acid screened sensitive skin subject (with scoring at 2.5 minutes and 5 minutes totaling ≥3) as confirmed at screening visit.
c. Subject is any Fitzpatrick Skin Type (to be recorded in the demographics).
d. Subject has skin type normal (at least 3 subjects), dry (at least 3 subjects), oily (at least 3 subjects) or combination (at least 3 subjects) (will be recorded in the demographics).
e. Subject exhibits no edema, no greater than barely perceptible (±) erythema, and no greater than slight (1) dryness of the test sites at baseline.
f. Subject agrees not to introduce any new cosmetic or toiletry products during the study.
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 CRL.
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 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.




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