Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis

Inclusion Criteria:

- Male or female subjects in good general health confirmed by medical history.

- Subjects with a clinical diagnosis of AD (according to the criteria of Hanifin and
Rajka) of moderate to severe intensity (ISGA score of 3 or 4) involving ≥25% to ≤50%
of total BSA located within treatable areas (Cohort 1), or ≥35% to ≤50% of total BSA
located within treatable areas (Cohorts 2 and 3), with treatable areas including all
but the face, axillae, groin, and scalp.

- Subjects with a normally functioning HPA axis, defined as a prestimulation serum
cortisol level >5 µg/100 mL, and a response to cosyntropin stimulation to >18 µg/100
mL (after approximately 30 minutes); both blood draws for this test should be
performed in the morning, if possible

- Female subjects of childbearing potential must have a negative urine pregnancy test,
must not be breastfeeding, and must agree to use an acceptable form of birth control
for the duration of the study. Female subjects of childbearing potential are defined
as all female subjects who have reached menarche and are not two years
postmenopausal or who have reached menarche and have not had a hysterectomy,
bilateral tubal ligation, and/or complete bilateral oophorectomy

Exclusion Criteria:

- Subjects who do not have a normally functioning HPA axis (as defined in the
inclusion criteria).

- Subjects with an abnormal sleep schedule or who work at night.

- Subjects who have used topical dermal corticosteroids or topical immunomodulators
(e.g., tacrolimus or pimecrolimus) within 3 weeks before Day 1, and subjects who are
using any systemic medication known to affect cortisol levels or HPA axis integrity,
systemic corticosteroids, an acute systemic course of corticosteroids, and/or any
biological medication within 30 days before Day 1.

- Subjects with concomitant medical or dermatologic disorders (neurodermatitis, skin
atrophy, striae, telangiectasia, etc.) that may interfere with study objectives
and/or evaluations.

- Subjects with active skin infection.

- Subjects with any known significant endocrinological disorder that may require
prohibited treatment, any known underlying disease that the investigator deems
uncontrolled and poses a safety risk for the subject while participating in the
study, known sensitivity to any ingredient of the study preparation, or a history of
adverse responses to topical or systemic steroid therapy.

- Subjects who are pregnant or nursing.

- Subjects who have used bleach baths, phototherapy, and/or tanning beds, and/or who
have had excessive sun exposure within 1 week before Day 1 and/or are planning to
use any of these during the study.

- Subjects who have participated in a clinical drug or device research study and/or
used any investigational treatment within the last 30 days before Day