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

NCT00117377 | Completed Phase 4

• 1 other identifier: CASM981C2436
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, pimecrolimus, cellular, molecular

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis

Study Arms (2)

1

EXPERIMENTAL

Pimecrolimus

Drug: Pimecrolimus

2

PLACEBO COMPARATOR

Placebo control twice daily application

Drug: Placebo

Interventions

Pimecrolimus DRUG

Pimecrolimus cream 1 % bid

Also known as: Elidel

1

Placebo DRUG

Placebo application bid

2

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (3)

Mount Sinai School of Medicine

New York, New York, United States

Location

New York University Hospital

New York, New York, United States

Location

Virginia Clinical Research, Inc

Norfolk, Virginia, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 6, 2005
• Study Start: April 1, 2004
• Study Completion: June 1, 2005
• Last Updated: December 17, 2007

Record last verified: 2007-12

Locations

US (3)