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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.
Information provided by:
Novartis Identifier:
First received: August 30, 2005
Last updated: April 22, 2008
Last verified: April 2008

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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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.


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00139581

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

Responsible Party: External Affairs, Novartis Identifier: NCT00139581     History of Changes
Other Study ID Numbers: CASM981C2314
Study First Received: August 30, 2005
Last Updated: April 22, 2008

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

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017