NCT00568412

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

9 months

First QC Date

December 3, 2007

Last Update Submit

February 15, 2015

Conditions

Mild to Moderate Atopic Dermatitis

Keywords

atopic dermatitis

Outcome Measures

Primary Outcomes (1)

  • Investigator's Global Assessment

    End of study compared to baseline

Secondary Outcomes (4)

  • EASI

    End of study compared to baseline

  • Affected body surface area

    End of study compared to baseline

  • Patient's assessment of itch, quality of sleep, and global assessment

    End of study compared to baseline

  • Children's Dermatological Life Quality Index

    End of study compared to baseline

Study Arms (2)

1

ACTIVE COMPARATOR

Zarzenda applied topically twice daily for three weeks

Device: Zarzenda

2

ACTIVE COMPARATOR

Elidel 1% cream, applied topically twice daily for three weeks

Drug: Elidel

Interventions

ZarzendaDEVICE

Topical cream, applied twice daily for three weeks

1
ElidelDRUG

1% cream, applied topically twice daily for three weeks

2

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • known allergy to one of the two treatments
  • known immunodeficiency
  • known hepatic or renal insufficiency
  • acute skin infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum

Bonn, 53105, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 6, 2007

Study Start

December 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

DE(1)