Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects

NCT00139581 | Completed Phase 4

• 1 other identifier: CASM981C2314
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is not being conducted in the United States. To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease "relapse".

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, children, infants, pimecrolimus, bid, od

Outcome Measures

Primary Outcomes (2)

• Time to relapse of atopic dermatitis (defined as the exacerbation of atopic dermatitis to the level where a topical corticosteroid or alternative therapy is required).

• Investigators Global Assessment (IGA) and pruritus (itch) assessment of atopic dermatitis at time of suspected relapse

Secondary Outcomes (2)

• Time to first recurrence of atopic dermatitis

• Eczema Area and Severity Index (EASI) and IGA assessments at several time points.

Study Arms (2)

1

EXPERIMENTAL

Pimecrolimus b.i.d.

Drug: Pimecrolimus

2

EXPERIMENTAL

Pimecrolimus o.d. and placebo o.d.

Drug: Pimecrolimus

Interventions

Pimecrolimus DRUG

Pimecrolimus cream 1 % applied twice daily (b.i.d.)

Also known as: Elidel b.i.d.

1

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age \>= 2 years through age \<=17 years of age
• IGA score of 2, 3, or 4 (mild, moderate, or severe AD) affecting \>5% TBSA
• outpatients

You may not qualify if:

• subjects who applied topical therapy (e.g. tar, topical corticosteroids) within 2 weeks prior to Screening
• subjects who received phototherapy (e.g. UVB, PUVA, Narrow Band) within 4 weeks of Screening
• subjects who received any systemic immunosuppressant
• subjects who received systemic steroids
• females who are pregnant or breast-feeding, or planning to become pregnant during the study
• subjects who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or have a history of malignancy (includes basal cell carcinoma, squamous cell carcinoma, melanoma)
• subjects with open skin infections (bacterial, viral or fungal) if at the application site.
• subjects will HSV (common cold sores) are allowed to participate in the study (if not at the application site).
• subjects who have head lice or scabies
• subjects who present with clinical conditions other than AD that may interfere with the evaluation (e.g., generalized erythroderma, acne, Netherton's Syndrome,psoriasis)
• subjects that require systemic therapy for the treatment of atopic dermatitis
• subjects with poor or no clinical response to tacrolimus ointment (Protopic®) or pimecrolimus cream 1%
• subjects who used any experimental or investigational drug or therapy within 6 weeks prior to Screening
• subjects who intend to use experimental or investigational drug therapy during the course of this study
• subjects with known hypersensitivity to pimecrolimus 1% or related drugs (see Investigator's Brochure)

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

This study is not being conducted in the United States

Novartis Pharma AG, Basel, Switzerland

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 Pharma AG

  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: August 30, 2005
• First Posted: August 31, 2005
• Study Start: September 1, 2004
• Study Completion: September 1, 2005
• Last Updated: April 23, 2008

Record last verified: 2008-04

Locations

CH (1)