P155-22 BIO DRY & RED FACE STUDY FOR WOMEN – New Dates Available

P155-22 BIO DRY & RED FACE STUDY FOR WOMEN – New Dates Available
Posted  June 20, 2022

START DATE06/30/2022
QUALIFICATIONSWomen Ages 20 to 65

NOTES: PRESCREENING IS REQUIRED with a clean makeup & product-free face.

  • Subject must have self-perceived dry skin, uneven skin tone/hyperpigmentation, & redness.
  • Visit 2 will be a 9-hour sequestered study.
  • No other face studies while on this study.
  • Group 1 will have Lifestyle photographs.
  • Subject must sign a photography release form.
  • Masks are optional while at Eurofins|CRL. If you do wear a mask,  you must remove it when requested for acclimation & photos.
  • Children are not allowed in the facility for visits 20 minutes or longer.

Please read Full Inclusion and Exclusion Criteria below carefully.

Group 4: Visits 1, 3 & 4:  9 a.m. to 12 p.m. & 2 to 3:30 p.m.
Visit 2:  Will be picked at Visit 1
V1:  Pickup – Thursday, 6/30 – 30 minutes
V2:  Baseline & 8 Hour Sequester – Thursday, 7/7 – 9 hours
V3:  Week 8 – Thursday, 9/1 – 1.5 hours
V4:  Week 12 – Thursday, 9/29 – 1.5 hours

Group 5: Visits 1, 3 & 4:  9:30 to 11:30 a.m. & 2 to 3 p.m.
Visit 2:  Will be picked at Visit 1
V1:  Pickup – Friday, 7/1 – 30 minutes
V2:  Baseline & 8 Hour Sequester – Friday, 7/8 – 9 hours
V3:  Week 8 – Friday, 9/2 – 1.5 hours
V4:  Week 12 – Friday, 9/30 – 1.5 hours

Inclusion Criteria:
a) Subject is female between the ages of 20-65 years old
b) Subject is Fitzpatrick I-V (Approximately 20% of each Fitzpatrick Type)
c) Subject has self-perceived dry skin
d) Subject has mild to moderate uneven skin tone, hyperpigmentation, and redness
e) Subject agrees to refrain from using exfoliating or brightening products on the face for the duration of the study
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 and anticipates being available for all study visits
h) Subject is willing to participate in all study evaluations
i) Subject is willing to refrain from the use of suntan salons and excessive exposure to the sun during the course of the study
j) Subject is in generally good health and has a current Panelist Profile Form on file at ECRL
k) Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study
l) Subject has signed an Informed Consent in conformance with 21 CFR Part 50: “Protection of Human Subjects”;
m) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164

Exclusion Criteria:
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 inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study
c) Subject has had extensive sun exposure in the week preceding the study
d) 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 influence the outcome of the study
e) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study
f) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
g) Subject does not exhibit any rashes, scratches or burn marks on the test site (face)
h) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind
i) Subject has diabetes

Fitzpatrick Scale

Fitzpatrick Scale

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