BIO P235 Face Cream Study


BIO P235 Face Cream Study
Posted  September 30, 2024

START DATE10/07/2024
QUALIFICATIONSMales and Females Ages: 18-75
FITZPATRICK TYPES1 2 3 4 5 6 
TIME REQUIREMENT3 visits
COMPENSATION$180

Prescreening is required in the BIO Department. Come in anytime to prescreen. 

We are now recruiting for ALTERNATES ONLY for this study. 

Conflicting Studies:  Any other face study

Study Description:

Visit 1/Pick-Up, panelists will report to ECRL WITH, a clean product/scratch-free face. Inclusion and exclusion criteria will be verified and informed consent will be obtained. Subjects will receive a daily dairy soap.

Visit 2/Baseline: Subjects will acclimate and have colorface images taken, dermalab measurements, Corneometer, vapometer, cutometer measurements. The product will be applied and all evaluations will be done again. Product will be distributed.

Visit 3/Week4: Subjects will acclimate and have colorface images taken, dermalab measurements, Corneometer, vapometer, cutometer measurements. Products will be collected

Inclusion Criteria

  • Subject is female or male between the ages of 18-75
  • Subject has mild to moderate of the following on the face:
    a. Uneven skin tone
    b. Fine lines
    c. Wrinkles
    d. Dull skin
  • Subject has normal or dry skin type (approximately 50% of each)
  • Male subject agrees to have shaved their whole face within 24 hours of each visit
  • Subject agrees not to introduce any new cosmetic or toiletry products during the study
  • Subject agrees to refrain from drinking hot/caffeinated beverages 2 hours prior to each study visit;
  • Subject agrees to stop using all moisturizing products for the duration of the conditioning phase and only use the designated test product during the study phase as instructed.
  • Subject agrees to use the provided soap for all face washing for the duration 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 in generally good health and has a current Panelist Profile Form on file at ECRL
  • Subject agrees to sign a Photography Release providing consent for the capture of digital images for use in relation to this clinical study
  • 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.”

Exclusion Criteria 

  • Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
  • Subject has facial piercings (unless piercings can be removed for all photography);
  • Subject has visible facial tattoos (including eyeliner, eyebrows, lipliner, etc.)
  • Subject has permanent fake eyelashes or eyelash extensions
  • Subject is currently using or have used in the past week any systemic or topical corticosteroids, nonsteroid anti-inflammatory drugs, antihistamines, sympathomimetics, and/or vasoconstrictors or any medication that, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study
  • Subject has gotten Botox or plan on getting Botox during the study period
  • Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
  • 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 exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test site, which might interfere with evaluations of test results
  • Subject is currently taking any medications which, in the opinion of the Principal Investigator, may interfere with the study
  • Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind
  • Subject has diabetes

Group 1

V1    20 min     Mon.  Oct. 7th

V2    1.5 hrs.    Mon. Oct. 14th

V3    1 hr.         Mon. Nov.11th

Appointment times:  8:00 am – 3:30 pm

 

Group 2

V1    20 min     Thurs.   Oct. 10th

V2    1.5 hrs.    Thurs.    Oct. 17th

V3    1 hr.         Tues..    Nov.12th

Appointment times:  8:00 am – 3:30 pm

 

Call our Recruiting Department for more information.

 


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