Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: Pimecrolimus
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis

Estimated Enrollment: 70
Study Start Date: April 2004
Study Completion Date: June 2005
Arms Assigned Interventions
Experimental: 1
Pimecrolimus
Drug: Pimecrolimus
Pimecrolimus cream 1 % bid
Other Name: Elidel
Placebo Comparator: 2
Placebo control twice daily application
Drug: Placebo
Placebo application bid

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117377

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States
New York University Hospital
New York, New York, United States
United States, Virginia
Virginia Clinical Research, Inc
Norfolk, Virginia, United States
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00117377     History of Changes
Other Study ID Numbers: CASM981C2436
Study First Received: June 30, 2005
Last Updated: December 13, 2007
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Austria: Federal Ministry for Health and Women
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Atopic dermatitis, pimecrolimus, cellular, molecular

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Pimecrolimus
Tacrolimus
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014