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

Pimecrolimus cream, 1% is a calcineurin inhibitor immunosuppressant. Pimecrolimus inhibits T
cell activation by blocking the transcription of early cytokines. Pimecrolimus cream, 1% is
indicated as second-line therapy for the short-term and non-continuous chronic treatment of
mild-to-moderate atopic dermatitis in non-immunocompromised adults and children 2 years of
age and older who have failed to respond adequately to other topical prescription
treatments, or when those treatments are not advisable. This study is being conducted to
evaluate the clinical bioequivalence of sponsor's formulation of Pimecrolimus Cream, 1%, the
Test product, and Elidel Cream, 1%, the Reference product. A vehicle control arm is included
to demonstrate that the Test and Reference products are active and to establish that the
study is sufficiently sensitive to detect differences between products.

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 respond
adequately to other topical prescription treatments for atopic dermatitis, or
subjects for 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 or
moderate (score of 2 or 3).

- An affected area of atopic dermatitis involvement of at least 5% of the body surface
area (BSA) at Visit 2/Day 1 (Baseline), as defined by the criteria of Hanifin and
Rajka (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 therapy
restrictions.

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

- In general good health, non-immunocompromised, and free from any clinically
significant disease, other than atopic dermatitis, that might interfere with the
study evaluations.

- Willing and able to understand and comply with the requirements of the study, apply
the study medication as instructed, return for the required study visits, comply with
therapy prohibitions, and complete the study.

- Female subjects of childbearing potential (excluding women who are surgically
sterilized [hysterectomy, bilateral tubal ligation, or bilateral ovariectomy] or have
been postmenopausal for at least 1 year) must have a negative urine pregnancy test
and must 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 of this study: oral contraceptives, contraceptive patches, contraceptive
implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide),
contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD
(Mirena®), Essure® permanent birth control, and abstinence with a documented second
acceptable method of birth control if the subject becomes sexually active. Subjects
entering the study who are on hormonal contraceptives must have been on the method
for at least 90 days prior to the study and continue the method for the duration of
the study. Subjects who had used hormonal contraception and stopped must have stopped
no less than 90 days prior to Visit 1.

Exclusion Criteria:

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

- 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, or
ichthyosis.

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

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

- Need or intent to continue to use any treatment listed in Table 9.1 during the
current study.