Moderate to Severe Atopic DermatitisNCT00148746
Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis
A study testing Pimecrolimus, Tacrolimus and Prednisolone in people with Moderate to Severe Atopic Dermatitis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The study was designed to test the hypothesis whether a standardized, time-and score-oriented treatment following a strict evidence based algorithm is equally effective to a standard treatment regimen for moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Moderate to Severe Atopic Dermatitis
- What is being tested?
- Pimecrolimus, Tacrolimus and Prednisolone
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- May 2004to Mar 2008
- Phase
- Interventional
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate to severe atopic dermatitis (SCORAD 20 or more) fulfilling the diagnostic criteria by Raika and Hanifin
Who cannot join
- Pregnancy
- Nursing
- Women in childbearing age without contraception
- Drug - and or alcohol abuse
- Gene defects that are associated with increased light sensibility, e.g. Xeroderma pigmentosum, Cockayne Syndrome, Bloom Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
The study was designed to test the hypothesis whether a standardized, time-and score-oriented treatment following a strict evidence based algorithm is equally effective to a standard treatment regimen for moderate to severe atopic dermatitis.
Study Type: Mono-centre study, patients are blinded, physicians are randomized to either treat study- or controll group
Eligible are patients age 2 years or older with SCORAD >= 20 Duration: 12 Months, study visits every 4 weeks.
Primary endpoint is Difference between Baseline SCORAD and mean SCORAD under treatment.
Secundary endpoints are quality of life, safety and economic burden in both treatment groups.
- Conditions
- Moderate to Severe Atopic Dermatitis
- Being tested
- Pimecrolimus, Tacrolimus, Prednisolone, Ciclosporin A, Dermatop
- Keywords
- atopic dermatitis, atopy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
TacrolimusDrug
PrednisoloneDrug
Ciclosporin ADrug
DermatopDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionSep 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Jochen M Schmitt, MD, MPH, Study director, Dpt. of Dermatology, Medical Faculty, Technical University Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148746
- Sponsor's protocol ID
- DERMA_AD_001
- Status last verified
- Jun 2010
- First submitted
- 6 Sep 2005
- Last updated
- 9 Jun 2010
- Results posted
- No
Publications
Schmitt J, Meurer M, Schwanebeck U, Grahlert X, Schakel K. Treatment following an evidence-based algorithm versus individualised symptom-oriented treatment for atopic eczema. A randomised controlled trial. Dermatology. 2008;217(4):299-308. doi: 10.1159/000151355. Epub 2008 Aug 15.
PubMed 18703875
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00148746
- Acronym / sponsor ID
- DERMA_AD_001
- Conditions
- Moderate to Severe Atopic Dermatitis
- Keywords
- atopic dermatitis, atopy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 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.
The study was designed to test the hypothesis whether a standardized, time-and score-oriented treatment following a strict evidence based algorithm is equally effective to a standard treatment regimen for moderate to severe atopic dermatitis.
Study Type: Mono-centre study, patients are blinded, physicians are randomized to either treat study- or controll group
Eligible are patients age 2 years or older with SCORAD >= 20 Duration: 12 Months, study visits every 4 weeks.
Primary endpoint is Difference between Baseline SCORAD and mean SCORAD under treatment.
Secundary endpoints are quality of life, safety and economic burden in both treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe atopic dermatitis (SCORAD 20 or more) fulfilling the diagnostic criteria by Raika and Hanifin
Key exclusion criteria (5 listed)
- Pregnancy
- Nursing
- Women in childbearing age without contraception
- Drug - and or alcohol abuse
- Gene defects that are associated with increased light sensibility, e.g. Xeroderma pigmentosum, Cockayne Syndrome, Bloom Syndrome
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 |
|---|---|---|
| Pimecrolimus | Drug | – |
| Tacrolimus | Drug | – |
| Prednisolone | Drug | – |
| Ciclosporin A | Drug | – |
| Dermatop | 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 Jun 2010.
- Derived from this study: PubMed 18703875Schmitt J, Meurer M, Schwanebeck U, Grahlert X, Schakel K. Treatment following an evidence-based algorithm versus individualised symptom-oriented treatment for atopic eczema. A randomised controlled trial. Dermatology. 2008;217(4):299-308. doi: 10.1159/000151355. Epub 2008 Aug 15.
Related trials for Moderate to Severe Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
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.
Jochen M Schmitt, MD, MPH study director
Dpt. 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 study testing Pimecrolimus, Tacrolimus and Prednisolone in people with Moderate to Severe 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 1 inclusion and 5 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 2010. 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.
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?
On the ClinicalTrials.gov record for NCT00148746, which also lists 1 linked publication.
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 2010.