Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185510

Purpose

Purpose of the study:

One bothering feature of atopic dermatitis is its relapsing nature. Hence, it is worthwhile to test modes how to efficiently prevent relapses or at least increase the time until the disease recurs. In order to give recommendations to other patients, this study is to scientifically describe efficacy and safety of a given regimen, namely a maintenance therapy with two days a week Advantan.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Methylprednisolonaceponate	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis With Advantan Cream

Further study details as provided by Bayer:

Primary Outcome Measures:

Time to relapse in the maintenance phase

Secondary Outcome Measures:

Patients’ assessment of relapse, IGA, mEASI, Index lesion monitoring, Patient Global Assessment, Visual assessment of signs of atrophy, Ultrasound for measurement of skin thickness in selected sites, Dermatology Life Quality Index (CDLQI, DLQI)
Spontaneously reported by patients, observed by or reported to investigator after indirect questioning

Study Start Date:	July 2005
Estimated Study Completion Date:	August 2006

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Acute ‘Severe’ or ‘Very Severe’ flare of atopic dermatitis; no minimum affected body surface
History of moderate to severe form of atopic dermatitis for at least two years

Exclusion Criteria:

Pregnancy, breast feeding
Known immune, hepatic, or renal insufficiency
Acute herpes simplex or mollusca contagiosa infection
Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion
Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis)
Acute infestations (e.g. head lice, scabies)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185510

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs.

Phone +49 30 468 11800

More Information

Study ID Numbers:	309189, EudraCT-No: 2004 – 002373-22
Study First Received:	September 15, 2005
Last Updated:	May 1, 2007
ClinicalTrials.gov Identifier:	NCT00185510
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Methylprednisolone aceponate
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases

Methylprednisolone
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009