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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00139581
First received: August 30, 2005
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

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".


Condition Intervention Phase
Atopic Dermatitis
Drug: Pimecrolimus
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: Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Time to first recurrence of atopic dermatitis
  • Eczema Area and Severity Index (EASI) and IGA assessments at several time points.

Study Start Date: September 2004
Study Completion Date: September 2005
Arms Assigned Interventions
Experimental: 1
Pimecrolimus b.i.d.
Drug: Pimecrolimus
Pimecrolimus cream 1 % applied twice daily (b.i.d.)
Other Name: Elidel b.i.d.
Experimental: 2
Pimecrolimus o.d. and placebo o.d.
Drug: Pimecrolimus
Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)
Other Name: Elidel o.d.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139581

Locations
Switzerland
This study is not being conducted in the United States
Novartis Pharma AG, Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharma AG Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00139581     History of Changes
Other Study ID Numbers: CASM981C2314
Study First Received: August 30, 2005
Last Updated: April 22, 2008
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Atopic dermatitis, children, infants, pimecrolimus, bid, od

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

ClinicalTrials.gov processed this record on April 22, 2014