A Multi Centre, Parallel, Randomised Study of the Skin Tolerance of Betamethasone Creams on Atopic Eczema and the Influence of Moisturiser Treatment on the Recurrence of Eczema
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- ACO Hud Nordic AB
- Enrollment
- 55
- Locations
- 5
- Primary Endpoint
- To study the compatibility of the skin with the new formulation in comparison to the reference medication.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1:1
Part 1 - eczema treatment
Intervention: betamethasone valerate (Drug)
1:2
Part 1 - eczema treatment
Intervention: betamethasone valerate (Drug)
2:1
Part 2 - maintenance treatment
Intervention: urea (Drug)
Outcomes
Primary Outcomes
To study the compatibility of the skin with the new formulation in comparison to the reference medication.
Time Frame: 3 weeks
To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.
Time Frame: Up to 6 months
Secondary Outcomes
- 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.)