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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00185510
First received: September 15, 2005
Last updated: February 23, 2014
Last verified: February 2014
  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.


Condition Intervention Phase
Dermatitis, Atopic
Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to relapse in the maintenance phase (MP) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

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

Enrollment: 250
Study Start Date: March 2005
Study Completion Date: June 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862)
In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.
Placebo Comparator: Arm 2 Drug: Placebo
2 days a week Vehicle (Advabase)

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185510

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185510     History of Changes
Other Study ID Numbers: 91424, 2004-002673-22, 309189
Study First Received: September 15, 2005
Last Updated: February 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone aceponate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents

ClinicalTrials.gov processed this record on September 16, 2014