P306-22 BIO BODY SERUM FOR WOMEN AGES 18 TO 67 – New Dates


P306-22 BIO BODY SERUM FOR WOMEN AGES 18 TO 67 – New Dates
Posted  November 22, 2022

START DATE12/08/2022
QUALIFICATIONSWomen Ages 18 to 67
TIME REQUIREMENT5 Visits
COMPENSATION$400

NOTES: PRESCREENING IS REQUIRED wearing clothing allowing access to test sites.

  • Subject must have mild to moderate loose/lax skin on all of the following areas: Breasts (outer/side) Thighs (back-behind knee/under buttocks), Buttocks (side), Abdomen, Arms (upper/outer).
  • Subjects must wear provided shorts and tank tops during study visits.
  • Subject cannot have sensitive skin.
  • No other body studies (including back patches & photo bio studies) – can only do face & hair studies.
  • Subject cannot have any skin disorder, irritation, sunburn, scarring, tattoos, cuts, scrapes or abrasion on the test sites.
  • Subject cannot currently be under treatment for asthma.
  • Masks are optional while at Eurofins|CRL. If you do wear a mask, you must remove it when requested for acclimation & photos.
  • Children are not allowed in the facility for visits 20 minutes or longer.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours:  8 to 11 a.m. & 1:15 to 4:15 p.m.

GROUP 6:
V1:  Pickup/Baseline – Thursday, 12/8 – 2 hours
V2: 
Week 1 – Thursday, 12/15 – 1.5 hours
V3: 
Week 4 – Thursday, 1/5 – 1.5 hours
V4:  Week 8 – Thursday, 2/2 – 1.5 hours
V5:  Week 12 – Thursday, 3/2 – 1.5 hours

Inclusions:
a) Subject is female between 18 and 65 years of age;
b) Subject has visible mild to moderate lose/lax skin on all of the following areas;
• Breasts (outer/side)
• Thighs (back – behind knee/under buttocks)
• Buttocks (side)
• Abdomen
• Arms (upper/outer)
c) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
d) Subject is willing to replace current body product(s) with the test material;
e) Subject agrees to wear provided shorts/shirt as designated by technician;
f) Subject as self-perceived non sensitive skin;
g) Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
h) Subject is willing to participate in all study evaluations;
i) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
k) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
l) Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects
m) Panelists must agree not to use any new personal care products during the course of the study;
n) Panelists willing to use the product all over their body below neck to ankles daily;
o) Panelists who agree to avoid excessive sun exposure and the use of artificial tanning methods.

Exclusions:
a) Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject is less than 6 weeks post-partum
c) Subject is on any body study; with the exception of face or hair studies
d) 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;
e) Subject is currently under treatment for asthma;
f) 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;
g) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
h) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
i) Subject has psoriasis, active atopic dermatitis, eczema, or sunburn at the test site




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