A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis - Full Text View

Sponsored by:	Intendis GmbH
Information provided by:	Intendis GmbH
ClinicalTrials.gov Identifier:	NCT00568412

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 IV

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Active Comparator Zarzenda applied topically twice daily for three weeks	Device: Zarzenda Topical cream, applied twice daily for three weeks
2: Active Comparator 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

Related Info This link exits the ClinicalTrials.gov site

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

Keywords provided by Intendis GmbH:

atopic dermatitis

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Skin Diseases, Eczematous
Pimecrolimus
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 15, 2009