Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis
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
3 other identifiers
interventional
250
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJune 9, 2023
February 1, 2014
1.2 years
September 15, 2005
June 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Time to relapse in the maintenance phase (MP)
Week 16
Secondary Outcomes (9)
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)
Week 16
Index lesion monitoring
Week 16
Change of disease during AP and MP as assessed by Patient Global Assessment
Week 16
- +4 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy, breast feeding
- Known immune, hepatic, or renal insufficiency
- Acute herpes simplex or mollusca contagiosa infection
- Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis)
- Acute infestations (e.g. head lice, scabies)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
- Bayercollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 16, 2005
Study Start
March 1, 2005
Primary Completion
May 1, 2006
Study Completion
June 1, 2006
Last Updated
June 9, 2023
Record last verified: 2014-02