A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical
administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne
vulgaris. The first 12 weeks of the study involves randomized, double-blind treatment with
active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double
blind portion of the study will be offered the opportunity to continue in the trial for up to
an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101,
4%.

Inclusion Criteria:

- Has facial acne vulgaris with:

- 20 to 50 inflammatory lesions (papules, pustules, and nodules)

- 25 to 100 noninflammatory lesions (open and closed comedones)

- No more than 2 nodules on the face

- IGA score of moderate (3) to severe (4)

- Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin
Cleanser) and to refrain from use of any other acne medication, medicated cleanser,
excessive sun exposure, and tanning booths for the duration of the study

Exclusion Criteria:

- Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any
dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)
that could interfere with the clinical evaluations

- Sunburn on the face