RCT of an Oral Acne Supplement for Adult Women

Inclusion Criteria:

1. Females subjects 18-50 years of age.

2. Subjects with mild to moderate (non-cystic) acne (8 inflammatory lesions, 10non-inflammatory lesions).

3. Subjects with an IGA score of 2-3

4. Subjects with all skin types (normal, oily, etc.)

5. Subjects with all Fitzpatrick skin types I-VI.

6. Subjects who agree to use only the provided study skin cleansing, moisturizing, andsunscreen products during the study duration.

7. Subjects agree not to introduce any new colored cosmetics (lipsticks, eye shadows,facial foundations, blush, powder) on their face.

8. No known medical conditions that, in the investigator's opinion, may interfere withstudy participation.

9. Women of childbearing potential must be willing to use a form of birth controlduring the study. For the purpose of this study, the following are consideredacceptable 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 theschedule 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) hassigned the Consent for Photograph Release and ICD including Health InsurancePortability and Accountability Act (HIPAA) disclosure.

14. Subject must avoid sun exposure.

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 withthe accurate evaluation of the subject's skin characteristics, except for the studycondition of acne.

2. Subjects who are not willing to use the assigned skin care study products to theirface as instructed and are not willing to take an oral acne supplement.

3. Females who are pregnant, lactating, or planning to become pregnant during the studyor within 30 days of study completion. (Subject must document her response in eitherthe source documentation or informed consent/assent forms).

4. Subject has a surgery and/or invasive medical procedure planned during the study.

5. Subject has observable suntan, scars, nevi, tattoo, excessive hair (including beard,mustache, or goatee), or other dermal conditions on the face that could interferewith study evaluations or confound study results, as determined by the PI ordesignee.

6. Subject has a history of or a concurrent health condition/situation which, in theopinion of the PI, if medically qualified, or study physician, may put theindividual at significant risk, confound the study results, or interferesignificantly with the individual's participation in the study.

7. Subject is an employee/contractor or immediate family member of the PI, Study Site,or Sponsor.

8. Subjects with clinically significant unstable medical disorders.

9. Subjects who are unwilling or unable to comply with the requirements of theprotocol.

10. Subjects with any known allergies or sensitivities to the study products.

11. Subjects who have a history of a psychological illness or condition that wouldinterfere with their ability to understand and follow the requirements of the study.

12. Subjects who have acne nodules/cysts representative of severe acne.

13. Subjects who are currently using, planning to use during the study or has used anyof 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), orhormones (pre- or post-menopausal hormone-replacement therapy; insulin, etc.),or other medications that could make skin more sensitive or have an effect onthe skin, as determined by the PI or designee. Oral contraceptives areacceptable.

• 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 antibacterialagents, topical anti-inflammatories, topical retinoids, etc.). Sunscreens (SPF) are acceptable.

14. Subject is taking medications that would mask an adverse event (AE) or influence thestudy results, including:

• Immunosuppressive drugs and steroidal and/or non-steroidal anti-inflammatorydrugs within 3 months before Visit 1 and during the study.

• Regular use of antihistamines within 1 month before Visit 1 and during thestudy.

15. Subject has a history of or a concurrent health condition/situation, which in theopinion of the PI, if medically qualified, or Study Physician, may put theindividual at significant risk, confound the study results, or interferesignificantly with the individual's participation in the study.

16. Subjects who are currently experiencing an acne flare.

17. Subjects having started hormone replacement therapies (HRT) or hormones for birthcontrol 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.

18. Subjects taking any medication or supplement that has a known interaction with anyof the study product ingredients, including but not limited to Berberine, which isassociated with inhibition of CYP450 enzymes.