Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Pimecrolimus Cream 1% (Valeant); Vehicle cream; Pimecrolimus Cream, 1%
Intervention MeSH terms: Pimecrolimus; Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 587.0
Sex: All
Minimum age: 12 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the safety and efficacy profiles of Watson
      Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America
      LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two
      active creams over that of the placebo (Vehicle of test product), in the treatment of mild to
      moderate atopic dermatitis.
    

Eligibility criteria:

        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.