check_circleStudy Completed

Dermatitis, Atopic

Bayer Identifier:

91424

ClinicalTrials.gov Identifier:

NCT00185510

EudraCT Number:

2004-002673-22

EU CT Number:

Not Available
Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis

Trial 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.

Key Participants Requirements

Sex

Both

Age

12 Years
  • - 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
  • - 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)

Trial summary

Enrollment Goal
250
Trial Dates
March 2005 - June 2006
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Advantan (Methylprednisolone Aceponate, BAY86-4862)
Accepts Healthy Volunteer
No

Primary Outcome

  • Time to relapse in the maintenance phase (MP)
    date_rangeTime Frame:
    Week 16
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Patients' number of relapses in the maintenance phase
    date_rangeTime Frame:
    Week 16
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    Safety Issue:
    No
  • Treatment success as assessed by Investigator Global Assessment (IGA) score
    date_rangeTime Frame:
    Week 16
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    Safety Issue:
    No
  • Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)
    date_rangeTime Frame:
    Week 16
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    Safety Issue:
    No
  • Index lesion monitoring
    date_rangeTime Frame:
    Week 16
    enhanced_encryption
    Safety Issue:
    No
  • Change of disease during AP and MP as assessed by Patient Global Assessment
    date_rangeTime Frame:
    Week 16
    enhanced_encryption
    Safety Issue:
    No
  • Visual assessment of signs of atrophy
    date_rangeTime Frame:
    Week 16
    enhanced_encryption
    Safety Issue:
    No
  • Ultrasound for measurement of skin thickness in selected sites
    date_rangeTime Frame:
    Up to week 16
    enhanced_encryption
    Safety Issue:
    No
  • Dermatology Life Quality Index (CDLQI, DLQI)
    date_rangeTime Frame:
    Week 16
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    Safety Issue:
    No
  • Adverse Event Collection
    date_rangeTime Frame:
    Week 16
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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