Efficacy and Safety Study of Advantan for Maintenance Tre... | NCT00185510

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

NCT00185510

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Jun 9, 2023Actual

Enrollment

250Actual

Phase

Phase 4

Conditions

Dermatitis, Atopic

Interventions

Methylprednisolone Aceponate (Advantan, BAY86-4862)
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2004-002673-22	EudraCT Number
309189	Other Identifier	Company internal

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

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

May 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Sep 15, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2023

Last Update Posted Date

Jun 9, 2023Actual

Name	Class
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862)
Arm 2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylprednisolone Aceponate (Advantan, BAY86-4862)	Drug	In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.	Arm 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Patients' number of relapses in the maintenance phase		Week 16
Treatment success as assessed by Investigator Global Assessment (IGA) score		Week 16
Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C078007	methylprednisolone aceponate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided