P217-22 BIO SEQUESTERED BLEMISH ERASER FOR MALES & FEMALES – New Dates Available


P217-22 BIO SEQUESTERED BLEMISH ERASER FOR MALES & FEMALES – New Dates Available
Posted  June 20, 2022

START DATE07/05/2022
QUALIFICATIONSMales & Females Ages 18 to 45
TIME REQUIREMENT2 Visits
COMPENSATION$170

NOTES: PRESCREENING IS REQUIRED with clean, product-free face.

  • Subject must have at least one moderate inflammatory papule on the right side and at least one moderate inflammatory papule on the left side of the face for a total of two lesions at baseline. There is no compensation if disqualified at Visit 1.
  • Males must be clean shaven and must shave 36 hours before baseline.
  • Visit 2 is a 9-hour sequestered visit. Subjects cannot leave the building for any reason during that time.
  • Subject cannot be currently taking or have taken oral or topical prescription medications for acne within the last 30 days.
  • No face studies within two weeks of the study start.
  • Masks are optional while at Eurofins|CRL. If you do wear a mask, you must remove it when requested by ECRL staff for acclimation and photos.
  • Children are not permitted in the facility for visits over 20 minutes.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours:
Visit 1:  10 a.m. to 2 p.m.
Visit 2: Will start at approximately 8 a.m. and will be determined at Visit 1.

Group 22:
Visit 1:  Screen / Pick-up – Tuesday, 7/5 – 30 minutes
Visit 2:  Baseline / Sequestered Visit – Wednesday, 7/6 – approx. 9 hours

Group 23:
Visit 1:  Screen / Pick-up – Tuesday, 7/19 – 30 minutes
Visit 2:  Baseline / Sequestered Visit – Wednesday, 7/20 – approx. 9 hours

Group 24:
Visit 1:  Screen / Pick-up – Monday, 7/25 – 30 minutes
Visit 2:  Baseline / Sequestered Visit – Tuesday, 7/26 – approx. 9 hours

Group 25:
Visit 1:  Screen / Pick-up – Thursday, 7/28 – 30 minutes
Visit 2:  Baseline / Sequestered Visit – Friday, 7/29 – approx. 9 hours

INCLUSION CRITERIA:
a) Subject is male or female between 18 and 45 years of age;
b) Subject has at least one moderate inflammatory papule on the right side and at least one moderate inflammatory papule on the left side of the face for a total of two lesions, to be confirmed at the Baseline visit;
c) Subject agrees to remove face mask for the acclimation period (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;
d) Subject agrees not to introduce any new cosmetic or toiletry products on face during the study;
e) Subject agrees to discontinue use of current acne treatments for the conditioning phase and for the duration of the study;
f) Subject is willing to be sequestered for approximately 9 hours in the testing facility at the baseline visit;
g) 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 visit;
h) Male subjects agree not to shave test site 36 hours before baseline visit;
i) Subject is dependable and able to follow directions as outlined in the protocol;
j) Subject is willing to participate in all study evaluations;
k) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
l) Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
m) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
n) Subject 18 years of age or older understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects” or subject under 18 years of age understands and is willing to sign a Minor Assent Form and the subject’s parent or legal guardian has signed an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.

EXCLUSION CRITERIA:
a) Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) 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;
c) Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would preclude application of the test material and/or could influence the outcome of the study;
d) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
e) Subject is currently taking or has taken within the last 30 days oral or topical prescription medications such for acne as: Drospirenone, Spironolactone, Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythrocycin, Vibramycin and topical tretinoin (Retin A Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo;
f) Subjects taking any systemic medication considered to affect the course of acne, especially, but not exclusively, antibiotics or steroids within the last 30 days;
g) Subject has used any topical over-the-counter (OTC) acne products (eg, adapalene, benzoyl peroxide, Differin®, salicylic acid, and/or alpha/beta/poly-hydroxy products or medicated cleansers, wipes, masks, scrubs, gels and creams) or any facial treatment products containing retinol, retinaldehyde, retinyl esters, salicylic acid, and/or alpha/beta/poly-hydroxy products within the last 30 days;
h) Subject is currently taking or has taken within the last six months oral isotretinoin (Accutane);
i) Subject has known sensitivity or allergy to cosmetics/toiletry products, salicylic acid, benzoyl peroxide, sulfur, and/or any topically applied medications;
j) Subject has participated in any clinical study which involved the face within two weeks of study initiation;
k) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
l) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
m) Subject has diabetes;
n) Subjects having observable sunburn, suntan, scars, nevi, excessive hair, tattoos, or other dermal conditions on the test sites that might influence the test results in the opinion of the Investigator or designee.
o) Subjects having any planned surgeries or invasive medical procedures during the course of the study. Non-invasive medical procedures or surgeries will be reviewed for their impact on the study outcome and acceptability by the Investigator or designee. Subjects having started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.




Sign up today!