P137 BIO ACNE REGIMEN FOR MALES & FEMALES


P137 BIO ACNE REGIMEN FOR MALES & FEMALES
Posted  May 21, 2021

START DATE06/07/2021
QUALIFICATIONSMale/Female ages 14 through 45 with mild to moderate Acne
FITZPATRICK TYPES1 2 3 4 5 6 
TIME REQUIREMENT5 visits
COMPENSATION$175

NOTES: ALL MINORS 13 TO 17 MUST BE ACCOMPANIED BY THEIR PARENT OR LEGAL GUARDIAN TO ALL STUDY VISITS.
* Prescreening is required for this study. SCROLL TO BOTTOM FOR CANFIELD ACNE IMAGE SCALE.

* All minors, parents or guardians must wear a face mask/face covering to all study visits.
* Males must be clean-shaven for study visits.
* Study participants must be willing to remove their masks for photos to be used with the study.
*Minor children other than the study participant are not permitted in the facility at this time.
* purses, other personal bags of any sort are not permitted in the facility at this time.
* All study participants must have Mild to Moderate acne. visible pores, clogged pores and oily skin.
* all study participants MUST STOP USING their usual acne products 14 days prior to the start of this study.

Study Hours:  9 a.m. to 12 p.m. and 1:40 p.m. to 4:40 p.m.
All Appointments will be at the same time

Group 3:
Visit 1:  Monday, 6/21 – 1.5 hours
Visit 2: Thursday, 6/24 – 1 hour
Visit 3: Monday, 6/28 – 1 hour
Visit 4: Monday, 7/19 – 1 hour
Visit 5: Tuesday, 8/17 – 1 hour

Group 4:
Visit 1:  Tuesday, 7/6 – 1.5 hours
Visit 2: Friday, 7/9 – 1 hour
Visit 3: Wednesday, 7/14 – 1 hour
Visit 4: Tuesday, 8/3 – 1 hour
Visit 5: Tuesday, 8/31 – 1 hour

INCLUSION CRITERIA
a) Subject is male (Approx. 25 %) or female (Approx. 75 %) of any ethnicity;
b) Subject is between 14 and 45 years of age (with not more than 5 subjects 36 – 45 years of age);
c) Subject has Fitzpatrick skin type I-IV (Approx. 75 %) or Fitzpatrick skin type V-VI (Approx. 25 %);
d) Subject has mild – moderate acne (2-3 on Canfield’s acne image scale), visible pores, clogged pores;
e) Subject has oily skin;
f) Subject has not used acne products 14 (±3 days) prior to their baseline visit;
g) Subject is a non-smoker;
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 duration of the study;
k) Subject agrees to avoid prolonged exposure to sunlight for the duration of this study;
l) Subject is dependable and able to follow directions as outlined in the protocol;
m) Subject is willing to participate in all study evaluations;
n) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
o) 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;
p) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;

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 known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
i) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
j) Subject has diabetes.

 




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