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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139581
• Other study ID #: CASM981C2314
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2005
• Last updated: April 22, 2008
• Start date: September 2004
• Est. completion date: September 2005

Study information

• Verified date: April 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenBelgium: Federal Agency for Medicines and Health Products, FAMHPFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

Inclusion criteria - Screening/Run-In Period

• 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

Exclusion Criteria:Screening/Run-In period

• 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)

• subjects who are non-compliant with general medical treatment, or are known to miss appointments, or don't intend to comply with the protocol for the duration of the study

• drug abuse, mental dysfunction, or other factors limiting the subject's ability to cooperate fully with study-related procedures

• subjects known to be unreliable or may be unable to complete the study

• any condition or prior/present treatment that would render the subject ineligible for the study

Inclusion criteria - Double-blind Maintenance treatment period

• Achieve complete remission of active disease (no signs or symptoms of AD) without incidence of "relapse" by the end of 6-week Run-In period (may be earlier); or who achieve "disease improvement" (decrease in IGA score by 1 full point confirmed by the investigator) without incidence of relapse at the end of the 6-week Run-In period

Exclusion criteria - Double-blind Maintenance treatment period

• subjects who experienced a "relapse" during the Run-In period

• subjects who applied topical corticosteroids or any alternative or additional therapy for the treatment of AD during the Run-In period

• subjects with active skin infections (bacterial, viral or fungal) except common cold sores (HSV) at the application site

• subjects who failed to record study medication use (and non use) and dosing regimen during the Run-In period

• subjects who failed to apply open label study drug twice daily until "disease remission" or end of the 6 week Run-In period

• subjects who failed to record concomitant medications during the Run-In period

• failure to return open-label study drug (used, partially used, and unused tubes) at the time double-blind study drug is dispensed. In order to avoid medication error, all open label study drug must be returned to the site before starting the Maintenance period

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus
Pimecrolimus cream 1 % applied twice daily (b.i.d.)
• Pimecrolimus
Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)

Locations

Country	Name	City	State
Switzerland	This study is not being conducted in the United States	Novartis Pharma AG	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	Investigators Global Assessment (IGA) and pruritus (itch) assessment of atopic dermatitis at time of suspected relapse
Secondary	Time to first recurrence of atopic dermatitis
Secondary	Eczema Area and Severity Index (EASI) and IGA assessments at several time points.