Skip to main content
OpenTrials
Completed

NCT Number: NCT00185510

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Methylprednisolone Aceponate (Advantan, BAY86-4862)

Drug

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

Placebo

Drug

2 days a week Vehicle (Advabase)

Primary outcomes

  1. Time to relapse in the maintenance phase (MP)

    Time frame: Week 16

Secondary outcomes

  1. Patients' number of relapses in the maintenance phase

    Time frame: Week 16

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

    Time frame: Week 16

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

    Time frame: Week 16

  4. Index lesion monitoring

    Time frame: Week 16

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

    Time frame: Week 16

  6. Visual assessment of signs of atrophy

    Time frame: Week 16

  7. Ultrasound for measurement of skin thickness in selected sites

    Time frame: Up to week 16

  8. Dermatology Life Quality Index (CDLQI, DLQI)

    Time frame: Week 16

  9. Adverse Event Collection

    Time frame: Week 16

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.