Clinical trial NCT00117377: Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis
Official title: Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis, pimecrolimus, cellular, molecular
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-07-06
Enrollment: 70
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Exclusion Criteria:

Exclusion criteria for patients with atopic dermatitis:

* Concurrent diseases/conditions and history of other diseases/conditions
* Are immunocompromised or have a history of malignant disease
* Have a history of rheumatic fever, heart valve replacement, prosthetic joints or other prosthetic constituents
* Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation
* Have previously reported poor or no clinical response to topical tacrolimus ointment (Protopic®) or pimecrolimus cream (Elidel®)
* Have active skin infections
* Present with clinical conditions other than atopic dermatitis that can interfere with the study treatment
* Present with severe medical condition(s) that, in the opinion of the investigator, prohibits participation in the study
* Are maintained on emollients that contain supplementary ingredients such as urea, alpha or beta-hydroxy acids, fruit acids, vitamins A, D or E
* Have received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 1 (screening)
* Have received systemic corticosteroids (\[CS\] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of Visit 1 (screening). Patients on a stable maintenance dose of inhaled or intranasal CS may participate
* Were treated with topical therapy, including topical calcineurin inhibitors (e.g. corticosteroids, tar) known or suspected to have an effect on AD during the current acute episode
* Were treated with antihistamines within 7 days of Visit 1
* Known serious adverse reactions or hypersensitivity to anesthetics such as lidocaine or mepivacaine
* Excluded investigational drugs/hypersensitivity
* Have received investigational drugs within 8 weeks of the first application of study drug or planned use of other investigational drugs during participation in this study
* Have known hypersensitivity to any ingredient of the pimecrolimus cream 1% or this class of study drug

Exclusion criteria for healthy volunteers:

* Erythrodermic patients, patients with Netherton's syndrome
* Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis)
* Clinically significant findings during the physical examination
* Have a history of rheumatic fever, heart valve replacement, prosthetic joints or other prosthetic constituents e.g. lens implants or hip joints
* Volunteers with known serious adverse reactions or hypersensitivity to anesthetics such as lidocaine or mepivacaine
* Participation in any clinical trial within one month prior to current trial
* History of immunocompromise
* History of positive hepatitis B surface antigen (HBsAg) or hepatitis C test result
* Use of corticosteroids within 4 weeks prior to baseline
* Were treated with antihistamines within 7 days of Visit 1
* Phototherapy within 4 weeks prior to baseline
* Topical therapy within 5 weeks prior to the study
* Treatment with nephrotoxic drugs within 2 weeks prior to baseline (aminoglycosides, amphotericin B, colchicine)

Primary outcomes:
measure: 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 outcomes:
measure: Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: New York University Hospital
state: New York
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: