Clinical trial NCT00576238: Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Eczema
Keywords: Atopic eczema
Topical corticosteroid
Lead sponsor: ACO Hud Nordic AB
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To study the compatibility of the skin with the new formulation in comparison to the reference medication.
timeFrame: 3 weeks
measure: To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.
timeFrame: Up to 6 months
Secondary outcomes:
measure: To study cosmetic acceptance of the corticosteroids
timeFrame: 3 weeks
measure: To study the safety of corticosteroid treatment.
timeFrame: 3 weeks
measure: To study the safety of maintenance treatment.
timeFrame: Up to 6 months.
Other outcomes:
Locations:
city: Nacka
country: Sweden
facility: Nacka hudmottagning
city: Nacka
country: Sweden
facility: Nacka närsjukhus
city: Stockholm
country: Sweden
facility: Sophiahemmet
city: Stockholm
country: Sweden
facility: Hudkliniken, Danderyds sjukhus
city: Vällingby
country: Sweden
facility: Läkarhuset Vällingby
Study officials:
affiliation: Hudkliniken, Akademiska sjukhuset, Uppsala
name: Berit Berne, MD
role: PRINCIPAL_INVESTIGATOR
References: