Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis

June 8, 2023 updated by: LEO Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Intendis GmbH, a Bayer HealthCare company, is the sponsor of the trial.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862)
In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.
Placebo Comparator: Arm 2
Drug: Placebo
2 days a week Vehicle (Advabase)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to relapse in the maintenance phase (MP)
Time Frame: Week 16
Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients' number of relapses in the maintenance phase
Time Frame: Week 16
Week 16
Treatment success as assessed by Investigator Global Assessment (IGA) score
Time Frame: Week 16
Week 16
Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)
Time Frame: Week 16
Week 16
Index lesion monitoring
Time Frame: Week 16
Week 16
Change of disease during AP and MP as assessed by Patient Global Assessment
Time Frame: Week 16
Week 16
Visual assessment of signs of atrophy
Time Frame: Week 16
Week 16
Ultrasound for measurement of skin thickness in selected sites
Time Frame: Up to week 16
Up to week 16
Dermatology Life Quality Index (CDLQI, DLQI)
Time Frame: Week 16
Week 16
Adverse Event Collection
Time Frame: Week 16
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Collaborators

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimated)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91424
  • 2004-002673-22 (EudraCT Number)
  • 309189 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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