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

Sponsor

ACO Hud Nordic AB (Industry)

Overall Status

Completed

CT.gov ID

NCT00576238

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Eczema	Drug: betamethasone valerate Drug: betamethasone valerate Drug: urea	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2004

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1:1 Part 1 - eczema treatment	Drug: betamethasone valerate Topical application according to a fixed schedule for three weeks Other Names: Betnoderm 0,1 % kräm
Active Comparator: 1:2 Part 1 - eczema treatment	Drug: betamethasone valerate Topical application according to a fixed schedule for three weeks Other Names: Betnovat kräm 0,1%
Experimental: 2:1 Part 2 - maintenance treatment	Drug: urea Topical application twice daily for up to 6 months Other Names: Canoderm kräm 5%
No Intervention: 2:2 Part 2 - maintenance treatment

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Nacka hudmottagning	Nacka	Sweden	13183
2	Nacka närsjukhus	Nacka	Sweden	13183
3	Sophiahemmet	Stockholm	Sweden	11486
4	Hudkliniken, Danderyds sjukhus	Stockholm	Sweden	18288
5	Läkarhuset Vällingby	Vällingby	Sweden	16862