P300-22 ADV. PRIMER FOR WOMEN – Alternates Needed

P300-22 ADV. PRIMER FOR WOMEN – Alternates Needed
Posted  September 22, 2022

START DATE10/11/2022
QUALIFICATIONSWomen Ages 18 to 50 with Acne-prone skin.


  • Subject must have self-perceived sensitive skin.
  • Subject must have acne-prone skin.
  • Subject cannot exhibit more than 10 inflammatory lesions (papules and pustules) at the baseline evaluation.
  • No other face or eye studies.
  • Masks are optional while at Eurofins|CRL. If you do wear a mask,  you must remove it when requested.
  • Children are not allowed in the facility for visits longer than 20 minutes.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours: 8 a.m. to 4 p.m.
Visit 1: 
Baseline – Tuesday, 10/11 – 20 minutes
Visit 2: 
Final – Tuesday, 11/8 – 20 minutes

Inclusion Criteria:
a) Subject is female between 18 and 50 years of age.
b) Subject has self-perceived sensitive skin.
c) Subject is any skin type; with a minimum of n=3 subjects of each skin type (normal, oily, dry and combination).
d) Subject exhibits no edema, no greater than barely perceptible (±) erythema, and no greater than slight (1) dryness of the test sites at baseline.
e) Subject has acne-prone skin.
f) Subject agrees not to introduce any new cosmetic or toiletry products during the study.
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.
j) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164.
k) Subject understands and is willing to sign 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 exhibits more than ten inflammatory lesions (papules and pustules) at the baseline evaluation.
d) 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.
e) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study.
f) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
g) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind.
h) Subject has insulin-dependent diabetes.

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