NOTES: PRESCREENING REQUIRED: To qualify subjects must have MILD to MODERATE acne. See below under inclusions.
* Exclusive study – Panelist cannot participate in any other studies.
* Visits 2 through 5 will take place on the same date, 2 hours apart.
* Study participants must be willing to remove their masks for photos.
* Minor children are not permitted in the facility at this time.
* Purses and other personal bags are not permitted in the facility at this time.
Study Hours: Visit 1: 9:20 to 11:20 a.m. & 2 – 3 p.m.;
Visit 2: 8 to 10 a.m.; Visit 3: 2 hours post-application; Visit 4: 4 hours post-application; Visit 5: 8 hours post-application.
Visits 6 & 7: Same time as Visit 1
Visit 1: Screening – Friday, 9/10: 30 minutes
Visit 2: Baseline – Thursday, 9/16: 1 1/2 hours
Visits 3, 4 and 5: Thursday, 9/16 at 2 hours, 4 hours & 8 hours post application – each visit 1 hour
Visit 6: Thursday, 9/30: 1 hour
Visit 7: Thursday, 10/14: 1 hour
Visit 1: Screening – Friday, 10/1: 30 minutes
Visit 2: Baseline – Wednesday, 10/6: 1 1/2 hours
Visits 3, 4 and 5: Wednesday, 10/6 at 2 hours, 4 hours & 8 hours post application – each visit 1 hour
Visit 6: Wednesday, 10/20: 1 hour
Visit 7: Wednesday, 11/3: 1 hour
Visit 1: Screening – Wednesday, 10/6: 30 minutes
Visit 2: Baseline – Monday, 10/11: 1 1/2 hours
Visits 3, 4 and 5: Monday, 10/11 at 2 hours, 4 hours & 8 hours post application – each visit 1 hour
Visit 6: Tuesday, 10/26: 1 hour
Visit 7: Monday, 11/8: 1 hour
Visit 1: Screening – Friday, 10/22: 30 minutes
Visit 2: Baseline – Wednesday, 10/27: 1 1/2 hours
Visits 3, 4 and 5: Wednesday, 10/27 at 2 hours, 4 hours & 8 hours post application – each visit 1 hour
Visit 6: Wednesday, 11/10: 1 hours
Visit 7: Wednesday, 11/24: 1 hour
Additional Groups will be scheduled – this is a Rolling recruit.
Subjects attending school will be allowed to choose later times for V1/V6/V7 if they need (appointments 3 p.m. to 4 p.m.)
a. Subject is male or female between 18 to 40 years of age;
b. Subject has Fitzpatrick Type II-VI (minimum of 10 subjects Fitzpatrick Type II-III and minimum of 20 subjects Fitzpatrick Type IV-VI with at least 5 subjects within each Fitzpatrick Type);
c. Subject has 8-24 facial lesions at the time of enrollment;
d. Subject has mild to moderate acne (score of 1-3 on IGA scale);
|Global Assessment Scale|
|1||Almost Clear||A few scattered comedones and a few small papules.|
|2||Mild||Easily recognizable; less than half the face is involved. Some comedones and some papules and pustules.|
|3||Moderate||More than half the face is involved. Many comedones, papules and pustules. One nodule may be present.|
e. Subject has at least one acne lesion on the face with a minimum size of 2mm;
f. Subject is willing to not take part in any cosmetic or clinical study for ECRL or any other company for the duration of the study;
g. Subject agrees to use only the test material(s) on the test site for the duration of the study;
h. Subject agrees not to wear any visible jewelry or makeup during the study visits;
i. Subject agrees to wear a ECRL-provided headband while images are taken;
j. Subject agrees not to introduce any new cosmetic or toiletry products during the study;
k. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
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 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 has completed a HIPAA Authorization Form in conformance with
45 CFR Parts 160 and 164;
p. Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”
a. Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b. Subject is currently using prescription or OTC topical anti-acne applications at the test site (face) including concurrent UV radiation treatment or has had any acne treatment by a dermatologist in the past 4 weeks;
c. Subject has used anti-acne skin care products in the past 4 weeks;
d. Subject has participated in any other clinical study involving an investigational product, in the opinion of the Principal Investigator, could affect the outcome of this study or a nutritional/supplement/intervention within 2 months of the study start;
e. Subject has an active skin disease of any type (eczema, severe acne (>50% of the face involved) psoriasis, dermatitis, etc.) on the test site;
f. Subject has cuts, lacerations, abrasions, bruises or excessive hair or blemishes on the test site;
g. Subject has tattoos on the test sites; however, permanent eyebrow, eyeliner, and lip liner are acceptable;
h. 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;
i. 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;
j. Subject has moles or excessive freckles on the test sites that could impair the evaluations as determined by the PI;
k. Subject reports a history of allergies or hypersensitivity to cosmetic products;
l. Subject is currently using topical retinoic acid, retinoids, retinol AHA or concurrent systemic treatments with steroids, antibiotics, antifungal treatments, antihistamines, immunomodulators within the past 3 months;
m. Subject is currently taking certain medications/receiving medical treatment which, in the opinion of the Principal Investigator, may interfere with the study;
n. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
o. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
p. Subject has diabetes;
q. Subject is an employee of the Sponsor or ECRL.