Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents
with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day
21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects
will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period

Inclusion Criteria:

- Otherwise healthy male and female adolescent subjects with moderate to severe acne
vulgaris on a 5 point IGA scale

- At least 20 total inflammatory lesions (papules and pustules), and at least 20 total
non-inflammatory lesions (open and closed comedones) on the face, chest, back, and
shoulders

- Age 9-16 years, 11 months inclusive

- Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse
co-oximeter

Exclusion Criteria:

- Subjects with any other acne-like dermatological conditions such as severe,
recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to
medications or other medical conditions, perioral dermatitis, clinically significant
rosacea, or gram-negative folliculitis;

- Any subject with skin disorders of an acute or chronic nature including psoriasis,
eczema, tinea versicolor, etc.

- Subjects who reside in a dwelling that relies on well water for a primary drinking
source

- Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings
that would interfere with assessments and study drug application

- Transgender subjects receiving hormone supplement (male to female or female to male)

- Subjects with a previous history of methemoglobinemia or taking medications known to
be associated with methemoglobinemia

- Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens

- Females who are pregnant, planning a pregnancy or breastfeeding

- Subjects previously treated with NVN1000 Gel / SB204