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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185510
• Other study ID #: 91424
• Secondary ID: 2004-002673-2230
• Status: Completed
• Phase: Phase 4
• Start date: March 2005
• Est. completion date: June 2006

Study information

• Verified date: February 2014
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Methylprednisolone Aceponate (Advantan, BAY86-4862)
In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.
• Placebo
2 days a week Vehicle (Advabase)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
LEO Pharma	Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to relapse in the maintenance phase (MP)		Week 16
Secondary	Patients' number of relapses in the maintenance phase		Week 16
Secondary	Treatment success as assessed by Investigator Global Assessment (IGA) score		Week 16
Secondary	Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)		Week 16
Secondary	Index lesion monitoring		Week 16
Secondary	Change of disease during AP and MP as assessed by Patient Global Assessment		Week 16
Secondary	Visual assessment of signs of atrophy		Week 16
Secondary	Ultrasound for measurement of skin thickness in selected sites		Up to week 16
Secondary	Dermatology Life Quality Index (CDLQI, DLQI)		Week 16
Secondary	Adverse Event Collection		Week 16