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

Phase 3

Completed

• Conditions: Atopic Eczema
• Interventions: Drug: urea; Drug: betamethasone valerate

• Registration Number: NCT00576238
• Lead Sponsor: ACO Hud Nordic AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Study Completion: 2008-02
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-10
• Last Update Posted: 2008-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2:1	urea	Part 2 - maintenance treatment
1:1	betamethasone valerate	Part 1 - eczema treatment
1:2	betamethasone valerate	Part 1 - eczema treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Nacka hudmottagning; 🇸🇪 Nacka, Sweden

Sophiahemmet; 🇸🇪 Stockholm, Sweden

Läkarhuset Vällingby; 🇸🇪 Vällingby, Sweden

Hudkliniken, Danderyds sjukhus; 🇸🇪 Stockholm, Sweden

Nacka närsjukhus; 🇸🇪 Nacka, Sweden