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

ACO Hud Nordic

Status and phase: Completed; Phase 3

Conditions: Atopic Eczema

Treatments: Drug: urea; Drug: betamethasone valerate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576238

ACO/02/08

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 4 patient groups

1:1

Experimental group

Description:

Part 1 - eczema treatment

Treatment:

Drug: betamethasone valerate

Drug: betamethasone valerate

1:2

Active Comparator group

Description:

Part 1 - eczema treatment

Treatment:

Drug: betamethasone valerate

Drug: betamethasone valerate

2:1

Experimental group

Description:

Part 2 - maintenance treatment

Treatment:

Drug: urea

2:2

No Intervention group

Description:

Part 2 - maintenance treatment