Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Inclusion Criteria:

- Males and females, 15 - 45 years of age

- Able to provide informed consent/assent; minors will provide assent while parent or
legal guardian will provide consent

- Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's
Global Assessment

- Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not
concentrated in one area

- Subject has Fitzpatrick skin phototype I, II or III

- Subject is in good health, willing to participate and able to comply with protocol
requirements

Exclusion Criteria:

- Severe acne (Investigator's Global Assessment 5) with significant scarring potential
and greater than 2 nodular lesions

- Clinically relevant history of keloids

- Facial tattoos

- Acne conglobata, acne fulminans, chloracne, drug-induced acne

- Active concomitant skin disease, excessive scarring or excess facial hair

- Heavily tanned skin; unable or unwilling to avoid tanning beds/excessive sun exposure

- Acne medication and therapy restrictions - time period prior to Baseline (below)

1. Oral retinoids - 6 months

2. Other systemic medications - 4 weeks

3. Topical retinoids, steroids, antibiotics - 2 weeks

4. OTC topical treatments - 1 week

5. Light treatments (including IPL or laser), microdermabrasion and/or peels - 8
weeks

6. Investigational drug, biologic or device - 30 days

7. Gold therapy of any type for any reason - EXCLUDED

- Pregnant, lactating, nursing or planning to become pregnant during the study period

- Known allergy to gold, ethanol, diisopropyl adipate, Polysorbate 80

- Clinically relevant condition that makes participation unsafe or that would interfere
with study treatment and assessment