Dermatitis, AtopicPhase 4NCT00185510
Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis
A Phase 4 study testing Methylprednisolone Aceponate (Advantan, BAY86-4862) in people with Dermatitis, Atopic, run by LEO Pharma.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Methylprednisolone Aceponate (Advantan, BAY86-4862)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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
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.
Read the 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.
- Conditions
- Dermatitis, Atopic
- Being tested
- Methylprednisolone Aceponate (Advantan, BAY86-4862), Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone Aceponate (Advantan, BAY86-4862)Drug
In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.
PlaceboDrug
2 days a week Vehicle (Advabase)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse in the maintenance phase (MP)
Measured: Week 16
Secondary outcomes (9)
Patients' number of relapses in the maintenance phase
Measured: Week 16
Treatment success as assessed by Investigator Global Assessment (IGA) score
Measured: Week 16
Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)
Measured: Week 16
Index lesion monitoring
Measured: Week 16
Change of disease during AP and MP as assessed by Patient Global Assessment
Measured: Week 16
Visual assessment of signs of atrophy
Measured: Week 16
Ultrasound for measurement of skin thickness in selected sites
Measured: Up to week 16
Dermatology Life Quality Index (CDLQI, DLQI)
Measured: Week 16
Adverse Event Collection
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionMay 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185510
- Sponsor's protocol ID
- 91424
- Other IDs
- 2004-002673-22, 309189, 2004
- Status last verified
- Feb 2014
- First submitted
- 15 Sep 2005
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00185510
- Acronym / sponsor ID
- 91424
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Mar 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone Aceponate (Advantan, BAY86-4862)In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week. | Drug | Arm 1 |
| Placebo2 days a week Vehicle (Advabase) | Drug | Arm 2 |
Primary outcome
Time to relapse in the maintenance phase (MP)
Time frame: Week 16
9 secondary outcomes
Patients' number of relapses in the maintenance phase
Time frame: Week 16
Treatment success as assessed by Investigator Global Assessment (IGA) score
Time frame: Week 16
Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)
Time frame: Week 16
Index lesion monitoring
Time frame: Week 16
Change of disease during AP and MP as assessed by Patient Global Assessment
Time frame: Week 16
Visual assessment of signs of atrophy
Time frame: Week 16
Ultrasound for measurement of skin thickness in selected sites
Time frame: Up to week 16
Dermatology Life Quality Index (CDLQI, DLQI)
Time frame: Week 16
Adverse Event Collection
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone Aceponate (Advantan, BAY86-4862) in people with Dermatitis, Atopic, run by LEO Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to relapse in the maintenance phase (MP) (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.