P339-22 BIO SEQUESTERED DRY FACE STUDY FOR WOMEN AGES 18 TO 65


P339-22 BIO SEQUESTERED DRY FACE STUDY FOR WOMEN AGES 18 TO 65
Posted  November 21, 2022

START DATE12/19/2022
QUALIFICATIONSWomen Ages 18 to 65 with dry skin
TIME REQUIREMENT2 Visits, 9 hours sequestered during visit 2
COMPENSATION$200

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

  • At prescreening, subjects will get corneometer measurements.
  • Subjects must have dry skin; Subjects with oily skin will not qualify.
  • Subject agrees to be sequestered in the facility for approx. 9 hours for visit 2.
  • No other face studies while on this study.
  • Subject cannot have any rashes, scratches, burn marks, or etc. on the face that would interfere with study evaluations
  • 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.

Study Hours:  8 to 9:30 a.m. & 2:30 to 3:30 p.m.

GROUP 1:
V1:  Pickup – Monday, 12/19 – 15 minutes
V2: 
Baseline – Wednesday, 12/21 – 9 hours sequestered

GROUP 2:
V1:  Pickup – Tuesday, 12/20 – 15 minutes
V2: 
Baseline – Thursday, 12/22 – 9 hours sequestered

GROUP 3:
V1:  Pickup – Friday, 12/23 – 15 minutes
V2: 
Baseline – Tuesday, 12/27 – 9 hours sequestered

GROUP 4:
V1:  Pickup – Monday, 12/26 – 15 minutes
V2: 
Baseline – Wednesday, 12/28 – 9 hours sequestered

GROUP 5:
V1:  Pickup – Tuesday, 12/27 – 15 minutes
V2: 
Baseline – Thursday, 12/29 – 9 hours sequestered

Inclusions:
• Subject is female between 18 to 65 years of age;
• Subject has an average baseline corneometer reading of 30 + 10 / side / zone 1, 3 and 4
o Zone 1 (Forehead) = sites 1-10
o Zone 3 (Nose & Cheek) = sites 11, 15-25
o Zone 4 (Lower Jaw) = sites 26-30
• Subject agrees not to wet or wash the test site after product application through completing the 8 hour timepoint;
• Subject agrees to discontinue use of all moisturizing products on the face for the duration of the study;
• Subject agrees to be sequestered in the Environmental Chamber at ambient conditions for approx. 9 hours
• Subject agrees not to introduce any new cosmetic or toiletry products during the study;
• Subject is willing to use the soap provided for the conditioning phase of the study
• Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
• Subject is willing to participate in all study evaluations;
• Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
• Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
• Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”

Exclusions:
• Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
• 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;
• 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;
• Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
• Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
• Subject exhibits any rashes, scratches, burn marks, or etc. on the test site (face) that would interfere with study evaluations;
• Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
• Subject reports a history or currently has diabetes




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