P167 BIO MASCARA 12 HOUR STUDY FOR WOMEN


P167 BIO MASCARA 12 HOUR STUDY FOR WOMEN
Posted  June 8, 2021

START DATE06/23/2021
QUALIFICATIONSWomen Ages 18 to 50 with medium to long lashes.
TIME REQUIREMENT4 Visits - 2 of the visits are on the same day - all visits are 30 minutes
COMPENSATION$100

NOTES: PRESCREENING IS REQUIRED with a clean, make-up free face. 
* Must have medium to long eyelashes.
* No tattoo cosmetics and/or fake eyelashes. Must have a clean, make-up free face at all visits.
* Visits 2 and 3 on this study will take place on the same day: Visit 2 is between 6:15 & 7:10 a.m., and Visit 3 is 12 hours post product application.
* You must wear a face mask/covering while at ECRL except when requested to remove it for acclimation and photos.
* Children, purses or other personal bags are not permitted in the facility at this time.

Study Times:
Visit 1: Between 8:30 a.m. and 3:45 a.m.
Visit 2 will be scheduled between 6:15 a.m. and 7:10 a.m. with the Bio department. Visit 2 will take place on the same day at 12 hours post application.
Visits 4 will be the same time as Visit 1

Group 1: all visits are 30 minutes.
Visit 1:  Wednesday, 6/23
Visit 2:  Thursday, 6/24
Visit 3: Same day as Visit 2 – 12 hours post application
Visit 4: Friday, 6/25

Group 2: all visits are 30 minutes.
Visit 1:  Monday, 6/28
Visit 2:  Tuesday, 6/29
Visit 3: Same day as Visit 2 – 12 hours post application
Visit 4: Wednesday, 6/30

Group 3: all visits are 30 minutes.
Visit 1:  Wednesday, 6/30
Visit 2:  Thursday, 7/1
Visit 3: Same day as Visit 2 – 12 hours post application
Visit 4: Friday, 7/2

Inclusion Criteria:
1. Subject is a female between the ages of 18-50 years old;
2. Subject agrees not to wash their face for 24 hours.
3. Subject has medium to long lashes.
4. 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;
5. Subject agrees not to introduce any new cosmetic or toiletry products during the study.
6. Subject is willing to use the accessory products and test product provided for the conditioning phase and duration of the study;
7. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
8. 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 ECRL.
9. Subject has signed an Informed Consent in conformance with 21 CFR Part 50: “Protection of Human Subjects”;
10. Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164.

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 fake eyelashes;
4. Subject has hooded eyelids.
5. 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;
6. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
7. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
8. Subject does not exhibit any rashes, scratches or burn marks on the test site (face);
9. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
10. Subject has diabetes.




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