P161 BIO ACNE SERUM FOR MEN & WOMEN – NEW DATES


P161 BIO ACNE SERUM FOR MEN & WOMEN – NEW DATES
Posted  September 13, 2021

START DATE09/17/2021
QUALIFICATIONSMale/Female ages 18 through 40, FITZ Skin Types II through VI & Mild to Moderate Acne
FITZPATRICK TYPES2 3 4 5 6 
TIME REQUIREMENT7 visits - visits 2 through 5 on the same day.
COMPENSATION$250

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

Group 2:
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

Group 3:
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

Group 4:
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

Group 5:
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.)

Inclusion Criteria

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
1Almost ClearA few scattered comedones and a few small papules.
2MildEasily recognizable; less than half the face is involved. Some comedones and some papules and pustules.
3ModerateMore 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.”

Exclusion Criteria
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.


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