P205 BIO STRETCH MARK TREATMENT STUDY FOR WOMEN – NEW DATES AVAILABLE


P205 BIO STRETCH MARK TREATMENT STUDY FOR WOMEN – NEW DATES AVAILABLE
Posted  December 1, 2021

START DATE12/10/2021
QUALIFICATIONSWomen Ages 18 to 45 with stretch marks on the abdomine.
TIME REQUIREMENT3 Visits
COMPENSATION$180

NOTES: PRESCREENING IS REQUIRED.
* Panelist must have stretch marks on the abdomen.
* Stretch marks whether or not postpartum, cannot be more than six years old.
* Panelist cannot be breast feeding
* Panelist cannot be on any other Bio or body studies.
* 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 Hours: 8 a.m. to 4 p.m.

GROUP 4
Visit 1: Baseline – Friday, 12/10 – 1.5 hours
Visit 2: Week 4 – Friday, 1/7 – 1.5 hours
Visit 3: Week 8 – Friday, 2/4 – 1.5 hours

Inclusion Criteria:
1. Subject is female between 18 and 45 years of age.
2. Subject (if postpartum) is at least 6 weeks postpartum.
3. Subject has moderate to severe abdominal stretch marks.
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;
9. Subject is willing to refrain from the use of suntan salons and excessive exposure to the sun during the course of the study;
10. Subject is in generally good health and has a current Panelist Profile Form on file at ECRL
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 signed an Informed Consent in conformance with 21 CFR Part 50: “Protection of Human Subjects”;
13. 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 is breast feeding.
3. 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;
4. 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;
5. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
6. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
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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