| Eligibility |
Inclusion Criteria:
1. Males and females 12+ years of age.
2. Subjects with mild to moderate acne.
3. Subjects must possess 10-100 total non-inflammatory lesions (open comedones and closed
comedones), 10-50 total inflammatory lesions, no cysts, and up to 2 nodules (if deemed
appropriate by the PI) on the face.
4. Subjects with all Fitzpatrick skin types I-VI.
5. Subjects who agree to use only the study products for acne treatment. No other
medicated cleansers or moisturizers or acne treatments of any kind are allowed.
6. Subjects agree not to introduce any new colored cosmetics or skin care products while
participating in the study (lipsticks, eye shadows, facial foundations, blush, powder,
cleansers, moisturizers).
7. Subjects agree to arrive at all visits with a clean face, having washed his/her face
and removed all facial and eye makeup products within 2 hours to 4 hours prior to the
visit and is not to use/apply any topical facial product(s) until the visit is
completed.
8. No known medical conditions that, in the investigator's opinion, may interfere with
study participation.
9. Women of childbearing potential must be willing to use a form of birth control during
the study. For the purpose of this study, the following are considered acceptable
methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier
methods (e.g., condom and spermicide) and abstinence.
10. Subjects are dependable and able to follow directions and willing to comply with the
schedule of visits.
11. Subjects in generally good physical and mental health.
12. Able to read, write, speak, and understand English
13. Individual (and/or his/her legally acceptable representative, as applicable) has
signed the Consent for Photograph Release and ICD (and/or Assent Document, as
applicable) including Health Insurance Portability and Accountability Act (HIPAA)
disclosure.
14. Subject must avoid sun exposure, or use sunscreen if sun exposure is unavoidable.
15. Subject must avoid professional or facial spa procedures during the study.
Exclusion Criteria:
1. Any dermatological disorder, which in the investigator's opinion, may interfere with
the accurate evaluation of the subject's skin characteristics, except for the study
condition of acne.
2. Subjects who are not willing to use the assigned study product to their face as
instructed.
3. Subjects who have acne nodules/cysts representative of severe acne.
4. Subjects who are currently using, planning to use during the study or has used any of
the following in the specified time range (based on subject report):
- 1 month prior to Visit 1: Prescription (oral or topically applied on the face)
antibiotics, inhaled steroids (except those prescribed for allergies), or
hormones (pre- or post-menopausal hormone-replacement therapy; insulin, etc.), or
other medications that could make skin more sensitive or have an effect on the
skin, as determined by the PI or designee. Oral contraceptives are acceptable.
- 1 month prior to Visit 1: Prescription medication for acne (e.g. doxycycline,
minocycline, clindamycin, sulfamethoxazole and trimethoprim [Bactrim],
tetracycline, erythromycin, azithromycin, or Vibramycin®)
- 1 month prior to Visit 1: Topical prescription retinoids (e.g. Retin-A®, Retin-A
Micro®, Renova®, Adapalene, Tazarotene, Avita®, Tazorac®, Avage®, Differin®),
azelaic acid, benzoyl peroxide, dapsone, sodium sulfacetamide, Epiduo®, or other
similar prescription drug on the face
- 6 months prior to Visit 1: Accutane or other oral retinoid
- 2 weeks prior to Visit 1: Any of the following on the face:
- Light therapy
- OTC topical medications/products (including antiacne or antibacterial
agents, topical anti-inflammatories, topical retinoids, etc.). Sunscreens
(SPF) are acceptable.
5. Females who are pregnant, lactating, or planning to become pregnant during the study
or within 30 days of study completion. (Subject must document her response in either
the source documentation or informed consent/assent forms).
6. Subject has a surgery and/or invasive medical procedure planned during the study.
7. Subject has observable suntan, scars, nevi, tattoo, excessive hair (including beard,
mustache, or goatee), or other dermal conditions on the face that that could interfere
with study evaluations or confound study results, as determined by the PI or designee.
8. Subject is taking medications that would mask an adverse event (AE) or influence the
study results, including:
- Immunosuppressive drugs and steroidal and/or non-steroidal anti-inflammatory
drugs within 3 months before Visit 1 and during the study.
- Regular use of antihistamines within 1 month before Visit 1 and during the study.
9. Subject has a history of or a concurrent health condition/situation, which in the
opinion of the PI, if medically qualified, or Study Physician, may put the individual
at significant risk, confound the study results, or interfere significantly with the
individual's participation in the study.
10. Subject is an employee/contractor or immediate family member of the PI, Study Site, or
Sponsor.
11. Subjects with clinically significant unstable medical disorders.
12. Subjects who are unwilling or unable to comply with the requirements of the protocol.
13. Subjects with any known allergies or sensitivities to the study acne products.
14. Subjects who are currently under the care of a dermatologist for acne.
15. Subjects who are currently experiencing an acne flare.
16. Subjects who have history of a psychological illness or condition that would interfere
with their ability to understand and follow the requirements of the study.
17. Subjects having started hormone replacement therapies (HRT) or hormones for birth
control less than 3 months prior to the study entry or who plan on starting, stopping
or changing doses of HRT or hormones for birth control during the study.
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