Acne Study Inclusion/Exclusion
Subjects must meet all of the following criteria to be eligible for study participation:
- Male or female at least 9 years of age and older;
- Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit);
- Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 40;
- Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 20 but no more than 100;
- Subjects with two or fewer facial nodules;
- Women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.)
- Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits;
- Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing;
- If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products If the subject wears makeup they must agree to use non-comedogenic makeup.
- Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for study participation:
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis;
- Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
- Evidence or history of cosmetic-related acne;
- Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the trial, or become pregnant during the study;
- Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; Subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the Subject expects to change dose, drug or discontinue estrogen use during the study;
- If female, subject has a history of hirsutism, polycystic ovarian disease or clinically significant menstrual irregularities;
- Treatment of any type of cancer within the last 6 months;
- Concomitant use of potentially irritating over-the-counter products that contain ingredients such as benzoyl peroxide, alpha-hydroxy acid, salicylic acid, retinol or glycolic acids;
- Subject intends to use a tanning booth or sunbathe during the study.
- Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
- Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study.
If you are interested in participating or would like more information, please call our office at (646) 604-4344, or email the clinical research manager Afrisina@schweigerderm.com