Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis

Inclusion Criteria:

- Male or non-pregnant, non-lactating female subjects 12 years of age and older.

- Non-immunocompromised, with a clinical diagnosis of mild to moderate AD that has
failed to respond adequately to other topical prescription treatments for atopic
dermatitis, or for whom those treatments are not advisable.

- Confirmed diagnosis of AD for at least 3 months using the diagnostic features as
described by Hanifin and Rajka.

- IGA score of 2 (mild) or 3 (moderate) and ≥ 5% BSA affected at baseline.

Exclusion Criteria:

- Active cutaneous bacterial, viral or fungal infection in any treatment area at
baseline (e.g., clinically infected AD).

- Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline
and history or presence of skin conditions that would interfere with evaluations.

- History or presence of Netherton's Syndrome, immunological deficiencies or diseases,
organ transplant, HIV, diabetes, malignancy, malignant or pre-malignant skin
conditions, serious active or recurrent infection, systemic immunosuppressive
regimens, clinically significant severe renal insufficiency or severe hepatic
disorders.

- Use within one month before baseline of 1) oral or intravenous corticosteroids, 2)
UVA/UVB therapy, 3) psoralen plus ultraviolet A therapy (PUVA), 4) tanning booths, 5)
non-prescription ultraviolet (UV) light sources, 6) immunomodulators or
immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10)
pimecrolimus.

- Use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene or
other vitamin D preparations, or 3) retinoids.

- Use within 7 days before baseline of: 1) antihistamines, 2) topical antibiotics, 3)
topical corticosteroids or 4) other topical drug products.