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

Atopic Eczema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576238
• Other study ID #: ACO/02/08
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2007
• Last updated: October 10, 2008
• Start date: January 2004
• Est. completion date: February 2008

Study information

• Verified date: October 2008
• Source: ACO Hud Nordic AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• betamethasone valerate
Topical application according to a fixed schedule for three weeks
• betamethasone valerate
Topical application according to a fixed schedule for three weeks
• urea
Topical application twice daily for up to 6 months

Locations

Country	Name	City	State
Sweden	Nacka hudmottagning	Nacka
Sweden	Nacka närsjukhus	Nacka
Sweden	Hudkliniken, Danderyds sjukhus	Stockholm
Sweden	Sophiahemmet	Stockholm
Sweden	Läkarhuset Vällingby	Vällingby

Sponsors (1)

Lead Sponsor	Collaborator
ACO Hud Nordic AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the compatibility of the skin with the new formulation in comparison to the reference medication.		3 weeks	Yes
Primary	To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.		Up to 6 months	No
Secondary	To study cosmetic acceptance of the corticosteroids		3 weeks	No
Secondary	To study the safety of corticosteroid treatment.		3 weeks	Yes
Secondary	To study the safety of maintenance treatment.		Up to 6 months.	Yes