Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mylan Inc.
With
DPT Laboratories, Ltd.
Age
8–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Non-immuno compromised male or female aged 8 years and older
Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
A diagnosis of AD for at least 3 months
An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
Affected area of AD involvement at least 5% body surface area (BSA)
Treated with a bland emollient for at least 7 days
You may not be if
Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
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
Concurrent disease or treatment likely to interfere with the study treatment or evaluations
Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products
Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
Clareo Health | Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
