Cutaneous Lupus ErythematosusPhase 2NCT00317681
Efficacy of Topical Tacrolimus in Different Subtypes With Cutaneous Lupus Erythematosus (CLE)
A Phase 2 study testing Tacrolimus ointment in people with Cutaneous Lupus Erythematosus, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy of topical tacrolimus in different subtypes of cutaneous lupus erythematosus. As shown by several groups activated memory T lymphocytes play a key role in the pathogenesis of lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Lupus Erythematosus
- What is being tested?
- Tacrolimus ointment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Feb 2007
- Phase
- Phase 2
- 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
- Cutaneous lupus erythematosus confirmed by histological analysis
- Topical use of glucocorticosteroids stopped at least two weeks before the start of the study
- Presence of two primary skin lesions with a clinical score ≥ 1
- Written informed consent available prior to any screening procedures
Who cannot join
- Systemic medication if taken for lupus erythematosus (e.g. chloroquine or hydroxychloroquine) started at least 6 months prior to the beginning of the study
- Women of childbearing potential using inadequate birth control measures
- Pregnancy and lactation
- Known hypersensitivity to tacrolimus or any of the excipients
- Patients receiving systemic immunosuppressive drugs and cytotoxic agents other than antimalarial agents
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich-Heine-University of Duesseldorf, Department of Dermatology
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: The Efficacy of Topical Tacrolimus in the Treatment of Cutaneous Lupus Erythematosus - a Multi-Center-Trial
The purpose of this study is to evaluate the efficacy of topical tacrolimus in different subtypes of cutaneous lupus erythematosus. As shown by several groups activated memory T lymphocytes play a key role in the pathogenesis of lupus erythematosus. Tacrolimus targets T lymphocytes and suppresses their activation by inhibiting the expression of cytokine genes, such as IL-2. Therefore, treatment of cutaneous lupus erythematosus with topical tacrolimus might result in an improvement of skin lesions in such patients.
Read the detailed description
In patients with cutaneous lupus erythematosus (CLE), topical corticosteroids are the mainstay of treatment; however, a long-term use can lead to numerous side effects including skin atrophy. Recently, topical tacrolimus has been suggested to be effective in patients with different manifestations of CLE as single or additive therapy. Its anti-inflammatory effect can be explained by inhibition of calcineurin and suppression of proinflammatory cytokines such as interleukins-2, -3, -4, granulocyte colony-stimulating factor, and tumour necrosis factor alpha. In this study, we evaluate the efficacy of tacrolimus in 30 patients with different forms of CLE (ACLE, SCLE, DLE, LET). During a period of 3 months tacrolimus ointment and its placebo are applied on two separate skin lesions. Clinical follow-up examinations including photo documentation are performed every 4 weeks.
- Conditions
- Cutaneous Lupus Erythematosus
- Being tested
- Tacrolimus ointment
- Keywords
- Cutaneous lupus erythematosus, Tacrolimus ointment, Topical treatment, Skin lesions
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus ointmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startAug 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Investigators
- Annegret Kuhn, MD, Principal investigator, Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317681
- Sponsor's protocol ID
- AMG 001
- Other IDs
- 2004-005020-41, 2004
- Status last verified
- Sep 2007
- First submitted
- 21 Apr 2006
- Last updated
- 10 Sep 2007
- Results posted
- No
Publications
Bacman D, Tanbajewa A, Megahed M, Ruzicka T, Kuhn A. [Topical treatment with tacrolimus in lupus erythematosus tumidus]. Hautarzt. 2003 Oct;54(10):977-9. doi: 10.1007/s00105-003-0593-3. No abstract available. German.
PubMed 14513247Kuhn A, Gensch K, Stander S, Bonsmann G. [Cutaneous lupus erythematosus. Part 2: diagnostics and therapy]. Hautarzt. 2006 Apr;57(4):345-8; quiz 359. doi: 10.1007/s00105-006-1138-3. German.
PubMed 16547761Kuhn A, Gensch K, Stander S, Bonsmann G. [Cutaneous lupus erythematosus. Part 1: clinical manifestations and classification]. Hautarzt. 2006 Mar;57(3):251-67; quiz 268. doi: 10.1007/s00105-006-1094-y. German.
PubMed 16501922
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Topical Tacrolimus in the Treatment of Cutaneous Lupus Erythematosus - a Multi-Center-Trial
- ClinicalTrials.gov ID
- NCT00317681
- Acronym / sponsor ID
- AMG 001
- Conditions
- Cutaneous Lupus Erythematosus
- Keywords
- Cutaneous lupus erythematosus, Tacrolimus ointment, Topical treatment, Skin lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 25 Apr 2006 (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 purpose of this study is to evaluate the efficacy of topical tacrolimus in different subtypes of cutaneous lupus erythematosus. As shown by several groups activated memory T lymphocytes play a key role in the pathogenesis of lupus erythematosus. Tacrolimus targets T lymphocytes and suppresses their activation by inhibiting the expression of cytokine genes, such as IL-2. Therefore, treatment of cutaneous lupus erythematosus with topical tacrolimus might result in an improvement of skin lesions in such patients.
Detailed description
In patients with cutaneous lupus erythematosus (CLE), topical corticosteroids are the mainstay of treatment; however, a long-term use can lead to numerous side effects including skin atrophy. Recently, topical tacrolimus has been suggested to be effective in patients with different manifestations of CLE as single or additive therapy. Its anti-inflammatory effect can be explained by inhibition of calcineurin and suppression of proinflammatory cytokines such as interleukins-2, -3, -4, granulocyte colony-stimulating factor, and tumour necrosis factor alpha. In this study, we evaluate the efficacy of tacrolimus in 30 patients with different forms of CLE (ACLE, SCLE, DLE, LET). During a period of 3 months tacrolimus ointment and its placebo are applied on two separate skin lesions. Clinical follow-up examinations including photo documentation are performed every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Cutaneous lupus erythematosus confirmed by histological analysis
- Topical use of glucocorticosteroids stopped at least two weeks before the start of the study
- Presence of two primary skin lesions with a clinical score ≥ 1
- Written informed consent available prior to any screening procedures
Key exclusion criteria (5 listed)
- Systemic medication if taken for lupus erythematosus (e.g. chloroquine or hydroxychloroquine) started at least 6 months prior to the beginning of the study
- Women of childbearing potential using inadequate birth control measures
- Pregnancy and lactation
- Known hypersensitivity to tacrolimus or any of the excipients
- Patients receiving systemic immunosuppressive drugs and cytotoxic agents other than antimalarial agents
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 |
|---|---|---|
| Tacrolimus ointment | Drug | – |
Primary outcome
Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score
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 10 Sep 2007.
- Background: PubMed 14513247Bacman D, Tanbajewa A, Megahed M, Ruzicka T, Kuhn A. [Topical treatment with tacrolimus in lupus erythematosus tumidus]. Hautarzt. 2003 Oct;54(10):977-9. doi: 10.1007/s00105-003-0593-3. No abstract available. German.
- Background: PubMed 16547761Kuhn A, Gensch K, Stander S, Bonsmann G. [Cutaneous lupus erythematosus. Part 2: diagnostics and therapy]. Hautarzt. 2006 Apr;57(4):345-8; quiz 359. doi: 10.1007/s00105-006-1138-3. German.
- Background: PubMed 16501922Kuhn A, Gensch K, Stander S, Bonsmann G. [Cutaneous lupus erythematosus. Part 1: clinical manifestations and classification]. Hautarzt. 2006 Mar;57(3):251-67; quiz 268. doi: 10.1007/s00105-006-1094-y. German.
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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.
Annegret Kuhn, MD principal investigator
Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus ointment in people with Cutaneous Lupus Erythematosus, run by Heinrich-Heine University, Duesseldorf 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 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 10 Sep 2007. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00317681, which also lists 3 linked publications.
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 10 Sep 2007; AzTrials last refreshed its copy on 7 Nov 2026.