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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185510

Enrollment

250

Registered

2005-09-16

Start date

2005-03-31

Completion date

2006-06-30

Last updated

2023-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic

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.

Interventions

DRUGMethylprednisolone Aceponate (Advantan, BAY86-4862)

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

DRUGPlacebo

2 days a week Vehicle (Advabase)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Patients' number of relapses in the maintenance phase	Week 16
Ultrasound for measurement of skin thickness in selected sites	Up to week 16
Dermatology Life Quality Index (CDLQI, DLQI)	Week 16
Adverse Event Collection	Week 16
Visual assessment of signs of atrophy	Week 16

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026