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

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Methylprednisolone Aceponate (Advantan, BAY86-4862)

Placebo

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Time to relapse in the maintenance phase (MP)

Secondary Outcome Measures

Patients' number of relapses in the maintenance phase

Treatment success as assessed by Investigator Global Assessment (IGA) score

Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)

Index lesion monitoring

Change of disease during AP and MP as assessed by Patient Global Assessment

Visual assessment of signs of atrophy

Ultrasound for measurement of skin thickness in selected sites

Dermatology Life Quality Index (CDLQI, DLQI)

Adverse Event Collection

Full Information

NCT ID

NCT00185510

First Posted

September 15, 2005

Last Updated

June 8, 2023

Sponsor

LEO Pharma

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00185510

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone Aceponate (Advantan, BAY86-4862)

Intervention Description

In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 days a week Vehicle (Advabase)

Primary Outcome Measure Information:

Title

Time to relapse in the maintenance phase (MP)

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Patients' number of relapses in the maintenance phase

Time Frame

Week 16

Title

Treatment success as assessed by Investigator Global Assessment (IGA) score

Time Frame

Week 16

Title

Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)

Time Frame

Week 16

Title

Index lesion monitoring

Time Frame

Week 16

Title

Change of disease during AP and MP as assessed by Patient Global Assessment

Time Frame

Week 16

Title

Visual assessment of signs of atrophy

Time Frame

Week 16

Title

Ultrasound for measurement of skin thickness in selected sites

Time Frame

Up to week 16

Title

Dermatology Life Quality Index (CDLQI, DLQI)

Time Frame

Week 16

Title

Adverse Event Collection

Time Frame

Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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