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

ACO Hud Nordic AB55 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Atopic Eczema

Interventions

betamethasone valerateDRUG

Topical application according to a fixed schedule for three weeks

betamethasone valerateDRUG

Topical application according to a fixed schedule for three weeks

ureaDRUG

Topical application twice daily for up to 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Nacka hudmottagning

Nacka, Sweden

Nacka närsjukhus

Nacka, Sweden

Sophiahemmet

Stockholm, Sweden

Hudkliniken, Danderyds sjukhus

Stockholm, Sweden

Läkarhuset Vällingby

Vällingby, Sweden

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

Time frame: 3 weeks

To study the safety of corticosteroid treatment.

Time frame: 3 weeks

To study the safety of maintenance treatment.

Time frame: Up to 6 months.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.