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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00576238

Enrollment

Registered

2007-12-19

Start date

2004-01-31

Completion date

2008-02-29

Last updated

2008-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Eczema

Keywords

Atopic eczema, Topical corticosteroid

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.

Interventions

DRUGbetamethasone valerate

Topical application according to a fixed schedule for three weeks

DRUGurea

Topical application twice daily for up to 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026