Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00117377
First received: June 30, 2005
Last updated: December 13, 2007
Last verified: December 2007

June 30, 2005
December 13, 2007
April 2004
Not Provided
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.
Not Provided
Complete list of historical versions of study NCT00117377 on ClinicalTrials.gov Archive Site
Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis
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Not Provided
Not Provided
 
Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis
Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: Pimecrolimus
    Pimecrolimus cream 1 % bid
    Other Name: Elidel
  • Drug: Placebo
    Placebo application bid
  • Experimental: 1
    Pimecrolimus
    Intervention: Drug: Pimecrolimus
  • Placebo Comparator: 2
    Placebo control twice daily application
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
June 2005
Not Provided

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)
Male
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00117377
CASM981C2436
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP