P194 BIO 12-Hour Sequestered Dry Skin Study


P194 BIO 12-Hour Sequestered Dry Skin Study
Posted  October 8, 2020

START DATE10/20/2020
QUALIFICATIONSMALE or FEMALE AGES 18 TO 50
FITZPATRICK TYPES1 2 3 4 5 
TIME REQUIREMENT5 visits visit 2 is a 13 hour Sequestered visit
COMPENSATION$425

NOTES: PRE-SCREENING IS REQUIRED FOR THIS STUDY. YOU MUST BE A NON-SMOKER.
* You MAY NOT be participating in any other study while on this one.
* You may not leave the facility for any reason during the sequestered portion of this study.
* Children are not permitted in the ECRL facility unless they have a scheduled pediatric study appointment.
* Sequestered Visit 2: lunch will not be provided.  You should bring any food, drinks and snacks you might require for the time period.  Foods must not require reheating.
*You must bring something with you to occupy your time during the sequester.
*DRY SKIN – ALTERNATES NEEDED 10/9
* FITZPATRICK SKIN TYPE V – ALTERNATES ONLY 10/16/20

Group 3: 
Visit 1: Tuesday, October 20  30 minutes
Visit 2: Tuesday, October 27, (start time chosen at visit 1 in Bio)  13 Hour Sequester
Visit 3: Wednesday, October 28 – 24 hour return post-application, 1 hour *** returning appointment will be in the morning only
Visit 4: Tuesday, November 3  1 hour
Visit 5: Tuesday, November 10  1 hour *** returning appointment will be in the afternoon only
Group 4:
Visit 1: Monday, November 2  30 minutes
Visit 2: Monday, November 9 , (start time chosen at visit 1 in Bio)  13 Hour Sequester
Visit 3: Tuesday, November 10 – 24 hour return post-application, 1 hour *** returning appointment will be in the morning only
Visit 4: Monday, November 16   1 hour
Visit 5: Monday, November 23   1 hour
Group 5: 
Visit 1: Wednesday, November 4  30 minutes
Visit 2: Wednesday, November 11,  (start time chosen at visit 1 in Bio)  13 Hour Sequester
Visit 3: Thursday, November 12 – 24 hour return post-application, 1 hour
Visit 4: Wednesday, November 18  1 hour *** returning appointment will be in the afternoon only
Visit 5: Wednesday, November 25  1 hour
Group 6: 
Visit 1: Tuesday, November 10  30 minutes
Visit 2: Tuesday, November 17, (start time chosen at visit 1 in Bio)  13 Hour Sequester
Visit 3: Wednesday, November 18 – 24 hour return post-application, 1 hour *** returning appointment will be in the morning only
Visit 4: Tuesday, November 24  1 hour
Visit 5: Tuesday, December 1   1 hour
Group 7: 
Visit 1: Friday, November 13  30 minutes
Visit 2: Thursday, November 19, (start time chosen at visit 1 in Bio)  13 Hour Sequester
Visit 3: Friday, November 20 – 24 hour return post-application, 1 hour *** returning appointment will be in the morning only
Visit 4: Wednesday, November 25  1 hour
Visit 5: Thursday, December 3   1 hour
INCLUSION CRITERIA: Male/Female ages 18 to 50; normal or sensitive skin, Fitzpatrick Skin types I-IV, Fitzpartick V = Alternates needed
*Subject has self-perceived dry skin on face and body; and visually mild to moderate dry skin in at least one body region at the screening visit and at baseline; (symmetrical on the arms or legs);
*Subject visually has mild to moderate dry skin on the face at the screening visit and at baseline;
*Subject agrees to not wash or rinse the test material off of the test site(s) during the sequestered visit and up to and including the 24 hour return visit;
*Subject agrees not to shave or wax the test sites within 48 hours prior to the baseline visit, and for the duration of the study visits;
*Subject agrees to wear loose clothing for easy access to the test sites (arms or legs) and wear pants and/or sleeves that can be easily rolled up;
*Subject is willing to be sequestered for approximately 13 hours in the testing facility at the baseline visit;
*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 agrees to sign a Photography Release Form in the event of an adverse event, providing consent for use of photography in relation to this clinical study;
EXCLUSION CRITERIA
*If Female , be pregnant, nursing, planning a pregnancy, or not using adequate birth control;
*Subject is participating on any other clinical study;
*Subject exhibits irritation, excessive hair, tattoos, sunburn, rashes, scratches, burn marks, scarring, acne etc. on the test sites, which might interfere with evaluation of test results;
*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 has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
*Subject has diabetes.




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