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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185510
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
LEO Pharma

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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Time to relapse in the maintenance phase (MP) [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Patients' number of relapses in the maintenance phase [ Time Frame: Week 16 ]
  2. Treatment success as assessed by Investigator Global Assessment (IGA) score [ Time Frame: Week 16 ]
  3. Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI) [ Time Frame: Week 16 ]
  4. Index lesion monitoring [ Time Frame: Week 16 ]
  5. Change of disease during AP and MP as assessed by Patient Global Assessment [ Time Frame: Week 16 ]
  6. Visual assessment of signs of atrophy [ Time Frame: Week 16 ]
  7. Ultrasound for measurement of skin thickness in selected sites [ Time Frame: Up to week 16 ]
  8. Dermatology Life Quality Index (CDLQI, DLQI) [ Time Frame: Week 16 ]
  9. Adverse Event Collection [ Time Frame: Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185510


Sponsors and Collaborators
LEO Pharma
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00185510    
Other Study ID Numbers: 91424
2004-002673-22 ( EudraCT Number )
309189 ( Other Identifier: Company internal )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: February 2014
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methylprednisolone aceponate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents