Assessing the Impact of Pioglitazone on Skin Barrier Function in Atopic Dermatitis Patients

Enrolled patients will be randomized to either placebo or pioglitazone. Each randomized
subject will have a skin biopsy and skin irritancy assay performed prior to treatment and at
the end of 12 weeks of treatment. Noninvasive barrier measurements including transepidermal
water loss will be recorded at all study visits.

Inclusion Criteria:

- i. Moderate to Severe AD: EASI ≥ 10 ii. Active Atopic Dermatitis: Subjects must have
within the last 3 months according to medical records or by medical exam of the
investigator:

- Pruritus

- Eczema (acute, subacute, chronic)

I. Typical morphology and age-specific patterns - Patterns include (1) facial, neck, and
extensor involvement in infants and children, (2) current or prior flexural lesions in any
age group, (3) sparing groin and axillary regions.

II. Chronic or relapsing history

iii. Extrinsic they must also meet both of the following: serum total IgE ≥ 1.5 S.D.
greater than the age-matched norms and positive multi-allergen RAST (Phadiatop).

Additionally, subjects must have TEWL of nonlesional skin of upper arm that is ≥ 8 gm/m2/h
at screening visit. This is to ensure that we are in fact studying the subset of AD
subjects who have a skin barrier defect.

Exclusion Criteria:

- Unwillingness or inability to complete the Informed Consent process

- Subjects with a history of keloid formation

- History of lidocaine or Novocain allergy

- Subjects with a systemic infection requiring a course of systemic antibiotics or
antivirals within the last 2 weeks

- Subjects with MD diagnosed Type 1 or 2 diabetes mellitus

- Subjects with NYHA class III or IV cardiac status

- Subjects with a history of liver disease (EtOH, viral hepatitis, drug-induced
hepatitis or other)

- Subjects with evidence of an underlying systemic disease based on history and
physical (other than the above diagnostic categories (and associated allergic
disorders), or well-controlled hypertension, or hyperlipidemia).

- History of cancer other than nonmelanomatous skin cancer or cervical dysplasia

- Participants enrolled while on a systemic treatment for their atopic dermatitis (e.g.
cyclosporine, mycophenolate mofetil) must remain on a stable dose for the duration of
the study