Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser

NCT ID: NCT00576238

Last Updated: 2008-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2008-02-29

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.

Conditions

Atopic Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1:1

Part 1 - eczema treatment

Group Type: EXPERIMENTAL

betamethasone valerate

Intervention Type: DRUG

Topical application according to a fixed schedule for three weeks

1:2

Part 1 - eczema treatment

Group Type: ACTIVE_COMPARATOR

betamethasone valerate

Intervention Type: DRUG

Topical application according to a fixed schedule for three weeks

2:1

Part 2 - maintenance treatment

Group Type: EXPERIMENTAL

urea

Intervention Type: DRUG

Topical application twice daily for up to 6 months

2:2

Part 2 - maintenance treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

betamethasone valerate

Topical application according to a fixed schedule for three weeks

Intervention Type: DRUG

betamethasone valerate

Topical application according to a fixed schedule for three weeks

Intervention Type: DRUG

urea

Topical application twice daily for up to 6 months

Intervention Type: DRUG

Other Intervention Names

Betnoderm 0,1 % kräm; Betnovat kräm 0,1%; Canoderm kräm 5%

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACO Hud Nordic AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Hudkliniken, Akademiska sjukhuset, Uppsala

Principal Investigators

Berit Berne, MD

Role: PRINCIPAL_INVESTIGATOR

Hudkliniken, Akademiska sjukhuset, Uppsala

Locations

Nacka hudmottagning

Nacka, , Sweden

Nacka närsjukhus

Nacka, , Sweden

Sophiahemmet

Stockholm, , Sweden

Hudkliniken, Danderyds sjukhus

Stockholm, , Sweden

Läkarhuset Vällingby

Vällingby, , Sweden

Countries

Sweden

Other Identifiers

ACO/02/08

Identifier Type: -

Identifier Source: org_study_id