NCT00180141

Brief Summary

Atopic dermatitis is a common disease. Emollients and Elidel have both shown to be effective to treat this disease. The research question is, whether the effective component (Elidel) is better than the emollient to improve the skin function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2005

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

Enrollment Period

1.9 years

First QC Date

September 12, 2005

Last Update Submit

May 6, 2008

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis on both lower arm.

Interventions

Elidel-CremeDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Atopic dermatitis on both lower arms at least 1% body surface area.
  • Atopic Dermatitis Severity Index (ADSI)-Score \>= 6
  • Investigator Global Assessment (IGA)-Score \>= 2

You may not qualify if:

  • Systemic therapy with immunosuppressive drugs within the past 24 weeks
  • Phototherapy against atopic dermatitis.
  • Antibiotic therapy against atopic dermatitis.
  • Allergy against Elidel.
  • Pregnancy
  • Nursing
  • Skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

  • Roland Aschoff, MD

    Department of Dermatology. Medical Faculty, Technical University Dresden, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

April 1, 2005

Primary Completion

March 1, 2007

Study Completion

June 1, 2007

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations

DE(1)