P096 BIO SPLIT FACE STUDY FOR WOMEN WITH FITZPATRICK SKIN TYPES II OR III


P096 BIO SPLIT FACE STUDY FOR WOMEN WITH FITZPATRICK SKIN TYPES II OR III
Posted  February 17, 2021

START DATE03/05/2021
QUALIFICATIONSWomen Ages 45-65, Fitzpatrick Skin Types II or III, Caucasian - Mild to moderate fine lines & wrinkles around the eye area, crow's feet area & forehead
FITZPATRICK TYPES2 3 
TIME REQUIREMENT2 Visits
COMPENSATION$80

NOTES: PRESCREENING IS REQUIRED
* You must wear a face mask/covering while at ECRL unless required to remove for photographs.
* You must be willing to replace the face mask if asked to do so.
* Children, purses or other personal bags are not permitted in the facility at this time.
*Study Hours:  Visit 1: 8 am to 10 a.m.; Visit 2 scheduled with Bio

Group 1:
Visit 1 – Friday, March 5 – 30 minutes
Visit 2 –  Wednesday, March 10 – 3 hours

Group 2:
Visit 1 – Friday, March 5 – 30 minutes
Visit 2 –  Thursday, March 11 – 3 hours

Inclusion Criteria:

  1. Subject is female between 45 and 65 years of age;
  2. Subject is Caucasian with a Fitzpatrick Skin Type of II or III;
  3. Subject has mild to moderate fine lines & wrinkles around the eye area and crow’s feet area, and forehead as determined by a trained ECRL technician;
  4. Subjects has mild to moderate uneven skin tone, redness, and rough skin;
  5. Subject agrees to use the non-moisturizing soap during the conditioning phase;
  6. Subject agrees to remove face mask for the acclimation period (for approximately 15 minutes 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;
  7. Subject agrees not to introduce any new cosmetic or toiletry products during the study;
  8. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
  9. Subject is willing to participate in all study evaluations;
  10. Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
  11. Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
  12. Subject has completed a HIPAA Authorization Form in conformance with
    45 CFR Parts 160 and 164;
  13. Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”

Exclusion Criteria:

  1. Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
  2. 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;
  3. 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;
  4. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
  5. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
  6. Subject does not exhibit any rashes, scratches, scars, or burn marks on the test site (face);
  7. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
  8. Subject has diabetes.

 

 




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