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 hasfailed to respond adequately to other topical prescription treatments for atopicdermatitis, or for whom those treatments are not advisable.

• Confirmed diagnosis of AD for at least 3 months using the diagnostic features asdescribed 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 atbaseline (e.g., clinically infected AD).

• Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baselineand 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 skinconditions, serious active or recurrent infection, systemic immunosuppressiveregimens, clinically significant severe renal insufficiency or severe hepaticdisorders.

• 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 orimmunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10)pimecrolimus.

• Use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene orother 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.