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A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT00568412
First received: December 3, 2007
Last updated: September 29, 2008
Last verified: September 2008
History of Changes
  Purpose

To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis


Condition Intervention Phase
Mild to Moderate Atopic Dermatitis
 Device: Zarzenda
Drug: Elidel
 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: A Multicenter, Randomized, Double-Blind Clinical Study to Examine the Efficacy and Safety of Zarzenda in Comparison to Elidel in the Management of Mild to Moderate Atopic Dermatitis in Children and Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:
  • Investigator's Global Assessment [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EASI [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
  • Affected body surface area [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
  • Patient's assessment of itch, quality of sleep, and global assessment [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
  • Children's Dermatological Life Quality Index [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Zarzenda applied topically twice daily for three weeks
 Device: Zarzenda
Topical cream, applied twice daily for three weeks
Active Comparator: 2
Elidel 1% cream, applied topically twice daily for three weeks
 Drug: Elidel
1% cream, applied topically twice daily for three weeks

  Eligibility

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

Inclusion Criteria:

  • male and female children and adolescents (aged 2 - 17)
  • mild to moderate atopic dermatitis
  • patients in whom a treatment with topical corticosteroids in not recommended or possible
  • wash out periods to be observed

Exclusion Criteria:

  • known allergy to one of the two treatments
  • known immunodeficiency
  • known hepatic or renal insufficiency
  • acute skin infections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568412

Locations
Germany
Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum
Bonn, Germany, 53105
Sponsors and Collaborators
Intendis GmbH
Investigators
Principal Investigator: Thomas Bieber, Prof Klinik und Poliklinik fuer Dermatologie, Universitaetsklinikum Bonn, Germany
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr Ulrike Ebert/Medical Advisor, Intendis GmbH
ClinicalTrials.gov Identifier: NCT00568412     History of Changes
Other Study ID Numbers: 1401920
Study First Received: December 3, 2007
Last Updated: September 29, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Intendis GmbH:
atopic dermatitis

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
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 May 16, 2013