Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis

Inclusion Criteria:

• Willing and able to provide written informed consent/assent for the study.

• Non-immunocompromised male or female aged 12 years or older.

• A clinical diagnosis of mild to moderate atopic dermatitis that has failed to respondadequately to other topical prescription treatments for atopic dermatitis, or subjectsfor whom the use of those other treatments is deemed inadvisable.

• A diagnosis of atopic dermatitis for at least 3 months.

• A baseline Investigator's Global Assessment (IGA) of disease severity of mild ormoderate (score of 2 or 3).

• An affected area of atopic dermatitis involvement of at least 5% of the body surfacearea (BSA) at Visit 2/Day 1 (Baseline), as defined by the criteria of Hanifin andRajka (1980).

• Treatment with a bland emollient for at least 7 days prior to Visit 2/Day 1 (Baseline).

• Agree to adhere to protocol-specified requirements and concomitant therapyrestrictions.

• Willing to avoid constant sun exposure and the use of tanning booths or other UV lightsources during participation in the study.

• In general good health, non-immunocompromised, and free from any clinicallysignificant disease, other than atopic dermatitis, that might interfere with the studyevaluations.

• Willing and able to understand and comply with the requirements of the study, applythe study medication as instructed, return for the required study visits, comply withtherapy prohibitions, and complete the study.

• Female subjects of childbearing potential (excluding women who are surgicallysterilized [hysterectomy, bilateral tubal ligation, or bilateral ovariectomy] or havebeen postmenopausal for at least 1 year) must have a negative urine pregnancy test andmust be willing to use a medically accepted method of contraception during the study.The following are considered acceptable methods of birth control for the purpose ofthis study: oral contraceptives, contraceptive patches, contraceptive implant, vaginalcontraceptive, double barrier methods (e.g., condom and spermicide), contraceptiveinjection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), Essure®permanent birth control, and abstinence with a documented second acceptable method ofbirth control if the subject becomes sexually active. Subjects entering the study whoare on hormonal contraceptives must have been on the method for at least 90 days priorto the study and continue the method for the duration of the study. Subjects who hadused hormonal contraception and stopped must have stopped no less than 90 days priorto Visit 1.

Exclusion Criteria:

• Females who were pregnant, breastfeeding, intending to become pregnant during thestudy, or who did not agree to use an acceptable form of birth control during thestudy.

• Active cutaneous bacterial or viral infection in any proposed treatment area at Visit 2/Baseline (e.g., clinically infected atopic dermatitis).

• Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Visit 2/Baseline that would interfere with the study evaluations.

• History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, orichthyosis.

• History or presence of Netherton's Syndrome, immunological deficiencies or diseases,HIV, diabetes, malignancy, serious active or recurrent infection, clinicallysignificant severe renal insufficiency, or severe hepatic disorders.

• Use of any treatment listed in Table 9.1 more recently than the indicated washoutperiod prior to Visit 2/Baseline.

• Need or intent to continue to use any treatment listed in Table 9.1 during the currentstudy.