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

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ClinicalTrials.gov Identifier: NCT00568412
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Mild to Moderate Atopic Dermatitis Device: Zarzenda Drug: Elidel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Investigator's Global Assessment [ Time Frame: End of study compared to baseline ]

Secondary Outcome Measures :
  1. EASI [ Time Frame: End of study compared to baseline ]
  2. Affected body surface area [ Time Frame: End of study compared to baseline ]
  3. Patient's assessment of itch, quality of sleep, and global assessment [ Time Frame: End of study compared to baseline ]
  4. Children's Dermatological Life Quality Index [ Time Frame: End of study compared to baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568412


Locations
Germany
Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum
Bonn, Germany, 53105
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00568412     History of Changes
Other Study ID Numbers: 1401920
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Keywords provided by Bayer:
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
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
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action