NCT00576238

Brief Summary

Topical steroid creams as well as moisturizing creams are important parts of the treatment strategy of atopic eczema. This study aims to investigate the tolerance of a new strong steroid cream in comparison to an already marketed reference cream with equal amount of active but with different cream vehicle. The second part of the study will investigate the possible preventative property of a moisturizing cream on skin that has been previously cleared from eczema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

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

January 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

October 13, 2008

Status Verified

October 1, 2008

First QC Date

December 18, 2007

Last Update Submit

October 10, 2008

Conditions

Atopic Eczema

Keywords

Atopic eczemaTopical corticosteroid

Outcome Measures

Primary Outcomes (2)

  • To study the compatibility of the skin with the new formulation in comparison to the reference medication.

    3 weeks

  • To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.

    Up to 6 months

Secondary Outcomes (3)

  • To study cosmetic acceptance of the corticosteroids

    3 weeks

  • To study the safety of corticosteroid treatment.

    3 weeks

  • To study the safety of maintenance treatment.

    Up to 6 months.

Study Arms (4)

1:1

EXPERIMENTAL

Part 1 - eczema treatment

Drug: betamethasone valerate

1:2

ACTIVE COMPARATOR

Part 1 - eczema treatment

Drug: betamethasone valerate

2:1

EXPERIMENTAL

Part 2 - maintenance treatment

Drug: urea

2:2

NO INTERVENTION

Part 2 - maintenance treatment

Interventions

betamethasone valerateDRUG

Topical application according to a fixed schedule for three weeks

Also known as: Betnoderm 0,1 % kräm
1:1
ureaDRUG

Topical application twice daily for up to 6 months

Also known as: Canoderm kräm 5%
2:1

Eligibility Criteria

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

You may qualify if:

  • Females and males between 18 and 65 years of age
  • Caucasian
  • AD according to the criteria of Hanifin and Rajka (12) with eczematous lesions corresponding to an Atopic Dermatitis Severity Index (ADSI) (13) score of at least 6 on any of the following areas: arms, legs, chest, abdomen or back
  • No serious health conditions that may interfere with the study
  • Written informed consent

You may not qualify if:

  • Eczematous regions exclusively in intertriginous areas or in the face
  • Use of topical steroids or any other dermatologic drug therapy (moisturising creams allowed) in the study area or light therapy within the preceding 2 weeks
  • Use of oral steroids within 1 month prior to the study
  • Use of concurrent medication e.g. medication that may interfere with the study related activities
  • Factors suggesting low compliance with study procedures
  • Possible allergy to ingredients in the study medications
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Nacka hudmottagning

Nacka, 13183, Sweden

Location

Nacka närsjukhus

Nacka, 13183, Sweden

Location

Sophiahemmet

Stockholm, 11486, Sweden

Location

Hudkliniken, Danderyds sjukhus

Stockholm, 18288, Sweden

Location

Läkarhuset Vällingby

Vällingby, 16862, Sweden

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Betamethasone ValerateUrea

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BetamethasonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAmidesOrganic Chemicals

Study Officials

  • Berit Berne, MD

    Hudkliniken, Akademiska sjukhuset, Uppsala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

January 1, 2004

Study Completion

February 1, 2008

Last Updated

October 13, 2008

Record last verified: 2008-10

Locations

SE(5)