Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, pimecrolimus, cellular, molecular
Brief summary
The purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy volunteers and patients with atopic dermatitis will be studied.
Interventions
DRUGPimecrolimus
Pimecrolimus cream 1 % bid
DRUGPlacebo
Placebo application bid
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for patients with atopic dermatitis: * Outpatient at screening * Adult male \>20 years old * Diagnosis of AD fulfilling the Hannifin and Rajka criteria * Mild to moderate AD (Investigator Global Assessment \[IGA\] 2-3; localized eczema area and severity index \[EASI\] 1-8) * AD affecting both arms and/or legs \>10cm2 per target area * Willing to undergo 4 mm serial punch biopsies * Patient history of AD for at least 3 years Inclusion criteria for healthy volunteers: * Volunteers must be males \>20 years of age * Volunteers must be in good health, as determined by past medical history, physical examination, and vital signs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining whether pimecrolimus cream has an effect on the cellular and molecular profile of atopic dermatitis skin, which is cleared of lesions and is otherwise clinically normal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis | — |
Countries
United States
Outcome results
None listed