An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris

Inclusion Criteria:

- Subject has moderate to severe facial acne vulgaris as determined by the
Investigator's Global Assessment (IGA) and obvious acne on the chest and/or back at
study start.

- Subject has facial acne vulgaris (including the nose) with a minimum number of
inflammatory lesions (papules, pustules, and nodules/cysts) and a minimum number of
non-inflammatory lesions (open and closed comedones) at study start.

- Females must be post-menopausal, surgically sterile or using highly effective birth
control methods with a negative urine pregnancy test (UPT) at study start.

- Subject must be in general good health in the opinion of the investigator, with
normal renal function, based on screening physical examination, medical history, and
clinical laboratory values.

Exclusion Criteria:

- Subject is pregnant, lactating, or is planning to become pregnant during the study.

- Subject is 12-20 years of age and has a Body Mass Index (BMI) for age percentile >
85%.

- Subject is > 20 years of age and has a BMI > 32.0 kg/m2.

- Subject has used tobacco, smoking cessation products, or products containing nicotine
within three months prior to study start.

- Except for the use of contraceptives, subject has used any prescription drug or
herbal product within 14 days prior to dosing, any non-prescription drug or vitamin
or mineral supplements within 7 days prior to study start; any known enzyme-inducer,
enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint
solvents or pesticides within 30 days of study start.

- Subject has used topical anti-acne medications containing retinoids such as
tazarotene, adapalene or tretinoin, within four weeks of study start.

- Subject has used the following systemic anti-acne medications: antibiotics within two
weeks of study start, spironolactone within four weeks of study start, or retinoid
therapy within three months of study start.

- Subject has any skin or medical condition, including facial hair that could interfere
with the evaluation of the test article or requires the use of interfering topical or
systemic therapy.

- Subject has the need or plans to be exposed to artificial tanning devices or
excessive sunlight during the study.

- Subject has used light treatments, microdermabrasion or chemical peels to the face,
chest and back within eight weeks of study start.

- Subject cannot avoid any type of strenuous exercise (swimming, running, team sports,
etc.,) or the use of hot tubs/saunas from study start to the end of the study.

- Subject has received an investigational drug or been treated with an investigational
device within 30 days prior to study start.

- Subject is currently enrolled in an investigational drug or device study.

- Subject has used topical corticosteroids (including inhaled and intranasal
corticosteroids) within two weeks of study start.

- Subject has used systemic corticosteroids (including intramuscular and intralesional
injections) within four weeks of study start.

- Subject has an irregular sleep schedule or works night shifts.

- Subject has experienced significant blood loss within 60 days or has donated plasma
within 72 hours prior to study start.

- Subject tests positive at Screening for human immunodeficiency virus (HIV) or is
known to be seropositive for HIV.

- Subject tests positive at Screening for hepatitis B surface antigen, hepatitis C
antibody or has a history of a positive result.

- Subject had major surgery within 30 days prior to study start or plans to have
surgery during the study.

- Subject has participated in a previous CB-03-01 study.