Atopic DermatitisPhase 4NCT00180141
Elidel-Study: Elidel in Patients With Atopic Dermatitis
A Phase 4 study testing Elidel-Creme in people with Atopic Dermatitis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Atopic dermatitis is a common disease. Emollients and Elidel have both shown to be effective to treat this disease. The research question is, whether the effective component (Elidel) is better than the emollient to improve the skin function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Elidel-Creme
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2005to Jun 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Atopic dermatitis on both lower arms at least 1% body surface area.
- Atopic Dermatitis Severity Index (ADSI)-Score >= 6
- Investigator Global Assessment (IGA)-Score >= 2
Who cannot join
- Systemic therapy with immunosuppressive drugs within the past 24 weeks
- Phototherapy against atopic dermatitis.
- Antibiotic therapy against atopic dermatitis.
- Allergy against Elidel.
- Pregnancy
- Nursing
- Skin cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Control of Therapy With Elidel vs Placebo in Patients With Atopic Dermatitis Using Bioengineering Methods
Atopic dermatitis is a common disease. Emollients and Elidel have both shown to be effective to treat this disease. The research question is, whether the effective component (Elidel) is better than the emollient to improve the skin function.
- Conditions
- Atopic Dermatitis
- Being tested
- Elidel-Creme
- Keywords
- Atopic dermatitis on both lower arm.
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elidel-CremeDrug
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 startApr 2005
- Primary completionMar 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Roland Aschoff, MD, Principal investigator, Department of Dermatology. Medical Faculty, Technical University Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180141
- Sponsor's protocol ID
- CASM981CDE16
- Status last verified
- May 2008
- First submitted
- 12 Sep 2005
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Therapy With Elidel vs Placebo in Patients With Atopic Dermatitis Using Bioengineering Methods
- ClinicalTrials.gov ID
- NCT00180141
- Acronym / sponsor ID
- CASM981CDE16
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis on both lower arm.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jun 2007 (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.
Atopic dermatitis is a common disease. Emollients and Elidel have both shown to be effective to treat this disease. The research question is, whether the effective component (Elidel) is better than the emollient to improve the skin function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Atopic dermatitis on both lower arms at least 1% body surface area.
- Atopic Dermatitis Severity Index (ADSI)-Score >= 6
- Investigator Global Assessment (IGA)-Score >= 2
Key exclusion criteria (7 listed)
- Systemic therapy with immunosuppressive drugs within the past 24 weeks
- Phototherapy against atopic dermatitis.
- Antibiotic therapy against atopic dermatitis.
- Allergy against Elidel.
- Pregnancy
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 |
|---|---|---|
| Elidel-Creme | Drug | – |
Primary outcome
Not reported in the source record.
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 May 2008.
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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.
Roland Aschoff, MD principal investigator
Department of Dermatology. Medical Faculty, Technical University Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elidel-Creme in people with Atopic Dermatitis, run by Technische Universität Dresden at 1 site in Germany.
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 4 inclusion and 7 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 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
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 May 2008; AzTrials last refreshed its copy on 3 Nov 2026.