P245 BIO ACNE SPOT TREATMENT FOR MALES & FEMALES – New Dates Coming


P245 BIO ACNE SPOT TREATMENT FOR MALES & FEMALES – New Dates Coming
Posted  January 5, 2022

START DATE01/19/2022
QUALIFICATIONSMales & Females ages 13 to 40 with at least one active pimple on each side of the face or body
TIME REQUIREMENT4 visits - visits 1 & 2 are on the same day.
COMPENSATION$150

NOTES: PRESCREENING REQUIRED with a product and makeup free face.
* Subjects must have moderate acne, visible pores, oily skin and at least 2 active pimples (one on each side of the face or body at Baseline.
*
* Visits 1 & 2 will take place on the same date, 2 hours apart.
* A parent or legal guardian must be present at Visit 1 to fill out all consenting paperwork.
* Study participants must be willing to remove their masks for photos.
* Minor children are not permitted in the facility at this time unless participating in a study.
* Purses and other personal bags are not permitted in the facility at this time.

Please read Inclusion & Exclusion criteria below carefully.

Study Hours: Visit 1:  9:15 to 3 p.m.
Visit 2: 2 hours post-application (same day as visit 1)
Visits 2 & 3: Same time as Visit 1 or will choose with Bio (9:15 a.m. to 4:00 p.m.)

  • Note: School-aged Subjects will be allowed to choose afternoon times for Visits 3 & 4 if needed. (appointments 2 to 4 p.m.)

GROUP 12:
Visit 1:  Baseline – Wednesday, 1/19 – 1.5 Hours
Visit 2: 2 Hours post application – Wednesday, 1/19 (same day as visit 1) – 45 Minutes
Visit 3: Day 2 – Friday, 1/21 – 1 Hour
Visit 4: Week 2 – Wednesday – 2/2 – 1 Hour

Additional Groups will be scheduled – this is a Rolling recruit.

Inclusion Criteria:
a) Subject is male or female between 13 and 40 years of age;
b) Subject is Latino/Hispanic (Approx. 20%), Caucasian (Approx. 40%), African American (Approx. 20%), Asian/Indian/Pakistani/PacificRim (Approx. 20%);
c) Subject has moderate acne on (both sides of the face) and visible pores; yes OR N/A
d) Subject has or does not have fungal acne (on face OR body), as determined by a Dermatologist; yes OR N/A
e) Subject presents with post-inflammatory hyperpigmentation;
f) Subject has oily skin;
g) Subject has not used acne products 14 (+/3 days) prior to their baseline visit;
h) 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;
i) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
j) Subject agrees to discontinue use of current acne treatments, moisturizers and products with moisturizing ingredients for the conditioning phase and for the duration of the study;
k) Subject is dependable and able to follow directions as outlined in the protocol;
l) Subject is willing to participate in all study evaluations;
m) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
n) Subject and parent/legal guardian (as applicable) agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
o) Subject is willing to sign a Model Release Form, providing consent for use of digital images in marketing materials;
p) Subject is willing to sign a Sponsor photo release waiver & QVC Affidavit;
q) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
r) 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 for acne such as 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) Subject is currently taking or has taken within the last six months oral isotretinoin (Accutane);
g) Subject has known sensitivity or allergy to cosmetics/toiletry products, salicylic acid, benzoyl peroxide, sulfur, and/or any topically applied medications;
h) Subject has participated in any clinical study which involving the test site within two weeks of study initiation;
i) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
j) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
k) Subject has diabetes.




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