- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00139581
Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects
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".
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Basel
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Novartis Pharma AG, Basel, Switzerland
- This study is not being conducted in the United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Pimecrolimus b.i.d.
|
Pimecrolimus cream 1 % applied twice daily (b.i.d.)
Other Names:
Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)
Other Names:
|
Experimental: 2
Pimecrolimus o.d. and placebo o.d.
|
Pimecrolimus cream 1 % applied twice daily (b.i.d.)
Other Names:
Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
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Time to first recurrence of atopic dermatitis
|
Eczema Area and Severity Index (EASI) and IGA assessments at several time points.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Calcineurin Inhibitors
- Tacrolimus
- Pimecrolimus
Other Study ID Numbers
- CASM981C2314
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
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Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
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ShaperonNot yet recruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of Scalp
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University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
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PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
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AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
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SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
-
National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
Clinical Trials on Pimecrolimus
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Actavis Inc.CompletedAtopic DermatitisUnited States
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Glenmark Pharmaceuticals Ltd. IndiaCompletedAtopic DermatitisUnited States
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Children's Hospital of PhiladelphiaNovartis PharmaceuticalsCompleted
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Mylan Inc.DPT Laboratories, Ltd.CompletedAtopic DermatitisUnited States, Dominican Republic, Honduras
-
Par Pharmaceutical, Inc.Completed
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NovartisCompletedDermatitis, AtopicUnited States
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GlaxoSmithKlineWithdrawnLymphoma, Follicular | Lymphoma, Non-Hodgkin | Lymphoma, Small Cleaved-Cell, Follicular | Lymphoma, Large-Cell, FollicularUnited States
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University of LeipzigNovartisWithdrawnLupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidGermany
-
University Hospital, GhentNovartisCompletedVitiligo VulgarisBelgium
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Mylan Inc.Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.Completed