Prurigo NodularisPhase 2CASM981CDE21NCT00507832
Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease
A Phase 2 study testing Pimecrolimus and Hydrocortisone in people with Prurigo Nodularis, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The development of the topical calcineurin inhibitor pimecrolimus resulted in a significant improvement in the treatment of atopic dermatitis. In addition, an excellent amelioration of pruritus could be regularly observed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- Pimecrolimus and Hydrocortisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2007to Oct 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 70 years
- Diagnosis: Prurigo nodularis
- Pruritus intensity above VAS 3 (Visual analoge scale 0 to 10)
- Nodules on arms and legs (target areas: arms)
- No effective current external or internal antipruritic medication
- Signed informed consent
Who cannot join
- prurigo nodularis with massive excoriations and/or local infections
- atopic dermatitis, predisposition for atopic dermatitis
- Itch intensity below VAS 4 (visual analoge scale 0 to 10)
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.
- Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. 'Medically approved' contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.
- active psychosomatic and psychiatric diseases
Show all 14Show fewer
- History of active malignancy of any organ system
- actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc)
- Systemic immunosuppression
- Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry
- current and past (within 2 weeks prior to study entry) systemic use of antihistamines, steroids, cyclosporin A and other immunosuppressants, paroxetin, fluvoxamine (selective serotonin reuptake- inhibitors, study possible in case of medication since 6 months due to depression without having any Antipruritic effect) naltrexone and UV-therapy.
- wound healing disturbances, disposition for keloids, current medication which leads to increased bleeding during procedure e.g. acetylsalicylic acid (ASS), marcumar (no suction blister possible)
- History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream
- Participation in other clinical studies within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The development of the topical calcineurin inhibitor pimecrolimus resulted in a significant improvement in the treatment of atopic dermatitis. In addition, an excellent amelioration of pruritus could be regularly observed. Up to now, several itchy dermatoses such as chronic irritative hand dermatitis, rosacea, graft-versus-host-disease, lichen sclerosus, prurigo simplex, scrotal eczema, and inverse psoriasis were reported as single cases also to respond to a pimecrolimus treatment.
In prurigo nodularis, pruritus is the main symptom and it is of immediate importance to find an effective antipruritic therapy. Pruritus is regularly severe and therapy refractory to topical steroids or systemic antihistamines. Capsaicin cream is one effective possibility to reduce the itch in these diseases. However, it has to be applied 3 to 6 times daily, rubs off on the clothing and induces burning in erosions. In addition, since no commercial preparation is available, it has to be prescribed in several concentrations. The application of pimecrolimus seems to be promising since it has to be applied twice daily only. Especially in prurigo nodularis we expect a good response as we could demonstrate in single patients. Furthermore it has been published recently that Tacrolimus, another calcineurin inhibitor has been successfully used in the treatment of six patients with prurigo nodularis.
This study is designed to compare the efficacy and safety of pimecrolimus 1% cream and hydrocortisone 1% cream in prurigo nodularis and to investigate the mode of action of the antipruritic effect of the drugs.
Read the detailed description
Patients will be treated with pimecrolimus cream 1% and hydrocortisone cream 1% twice daily for 8 weeks on diseased skin in a double-blind, randomized within patient comparison (left arm pimecrolimus, right arm hydrocortisone or vice versa). Patients will then enter a 4-week treatment free follow-up period. The overall study duration is 12 months.
The study population will consist of a representative group of 30 adult patients (18 - 70 years of age) with prurigo nodularis from one center in Germany.
Inclusion criteria
- Age: 18 - 70 years
- Diagnosis: Prurigo nodularis
- Pruritus intensity above VAS 3 (Visual analogue scale 0 to 10)
- Nodules on arms and legs (target areas: arms)
- No effective current external or internal antipruritic medication
- Signed informed consent
Exclusion criteria
- prurigo nodularis with massive excoriations and/or local infections
- atopic dermatitis, predisposition for atopic dermatitis
- Itch intensity below VAS 4 (visual analoge scale 0 to 10)
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.
- Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. 'Medically approved' contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.
- active psychosomatic and psychiatric diseases
- History of active malignancy of any organ system
- actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc)
- Systemic immunosuppression
- Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry
- current and past (within 2 weeks prior to study entry) systemic use of antihistamines, steroids, cyclosporin A and other immunosuppressants, paroxetin, fluvoxamine (selective serotonin reuptake- inhibitors, study possible in case of medication since 6 months due to depression without having any Antipruritic effect) naltrexone and UV-therapy.
- wound healing disturbances, disposition for keloids, current medication which leads to increased bleeding during procedure e.g. acetylsalicylic acid (ASS), marcumar (no suction blister possible)
- History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream
- Participation in other clinical studies within the last 4 weeks
- Conditions
- Prurigo Nodularis
- Being tested
- Pimecrolimus, Hydrocortisone
- Keywords
- Prurigo nodularis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
Also called Elidel Cream 1%
twice daily topical
HydrocortisoneDrug
Also called Hydrocortisone HExal
twice daily topical
PimecrolimusDrug
Also called Elidel 1% Cream
topical application as a cream twice daily
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Interindividual design:
active and comparator (one side each) applied twice daily Receives: Drug: Pimecrolimus |
| II Hydrocortisone | Active comparator | Hydrocortisone, twice daily Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothesis: pimecrolimus is superior in the reduction of the itch intensity on a visual analogue scale (VAS) compared to hydrocortisone cream 1%. H1: mean value VAS pimecrolimus < mean value VAS hydrocortisone
Measured: 12 months
Secondary outcomes (2)
Improvement of total symptom score (papule, nodules, excoriations, crusting, erythema) scored from 0-3 for each single symptom
Measured: 12 months
Change of skin neuropeptide content in suction blisters
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2009
- Study completionOct 2009
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 Prurigo NodularisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Investigators
- Thomas A Luger, MD, Principal investigator, Department of Dermatology, University of Münster, Von-Esmarch-Str. 58, D-48149 Münster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507832
- Sponsor's protocol ID
- SST-Pr-2-2005
- Acronym
- CASM981CDE21
- Status last verified
- Feb 2009
- First submitted
- 26 Jul 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stander S, Stander H, Seeliger S, Luger TA, Steinhoff M. Topical pimecrolimus and tacrolimus transiently induce neuropeptide release and mast cell degranulation in murine skin. Br J Dermatol. 2007 May;156(5):1020-6. doi: 10.1111/j.1365-2133.2007.07813.x. Epub 2007 Mar 28.
PubMed 17388925Stander S, Luger TA. [Antipruritic effects of pimecrolimus and tacrolimus]. Hautarzt. 2003 May;54(5):413-7. doi: 10.1007/s00105-003-0521-6. Epub 2003 Mar 21. German.
PubMed 12719860Senba E, Katanosaka K, Yajima H, Mizumura K. The immunosuppressant FK506 activates capsaicin- and bradykinin-sensitive DRG neurons and cutaneous C-fibers. Neurosci Res. 2004 Nov;50(3):257-62. doi: 10.1016/j.neures.2004.07.005.
PubMed 15488288
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease
- ClinicalTrials.gov ID
- NCT00507832
- Acronym / sponsor ID
- CASM981CDE21 / SST-Pr-2-2005
- Conditions
- Prurigo Nodularis
- Keywords
- Prurigo nodularis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Apr 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Jul 2007 (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 development of the topical calcineurin inhibitor pimecrolimus resulted in a significant improvement in the treatment of atopic dermatitis. In addition, an excellent amelioration of pruritus could be regularly observed. Up to now, several itchy dermatoses such as chronic irritative hand dermatitis, rosacea, graft-versus-host-disease, lichen sclerosus, prurigo simplex, scrotal eczema, and inverse psoriasis were reported as single cases also to respond to a pimecrolimus treatment.
In prurigo nodularis, pruritus is the main symptom and it is of immediate importance to find an effective antipruritic therapy. Pruritus is regularly severe and therapy refractory to topical steroids or systemic antihistamines. Capsaicin cream is one effective possibility to reduce the itch in these diseases. However, it has to be applied 3 to 6 times daily, rubs off on the clothing and induces burning in erosions. In addition, since no commercial preparation is available, it has to be prescribed in several concentrations. The application of pimecrolimus seems to be promising since it has to be applied twice daily only. Especially in prurigo nodularis we expect a good response as we could demonstrate in single patients. Furthermore it has been published recently that Tacrolimus, another calcineurin inhibitor has been successfully used in the treatment of six patients with prurigo nodularis.
This study is designed to compare the efficacy and safety of pimecrolimus 1% cream and hydrocortisone 1% cream in prurigo nodularis and to investigate the mode of action of the antipruritic effect of the drugs.
Detailed description
Patients will be treated with pimecrolimus cream 1% and hydrocortisone cream 1% twice daily for 8 weeks on diseased skin in a double-blind, randomized within patient comparison (left arm pimecrolimus, right arm hydrocortisone or vice versa). Patients will then enter a 4-week treatment free follow-up period. The overall study duration is 12 months.
The study population will consist of a representative group of 30 adult patients (18 - 70 years of age) with prurigo nodularis from one center in Germany.
Inclusion criteria
- Age: 18 - 70 years
- Diagnosis: Prurigo nodularis
- Pruritus intensity above VAS 3 (Visual analogue scale 0 to 10)
- Nodules on arms and legs (target areas: arms)
- No effective current external or internal antipruritic medication
- Signed informed consent
Exclusion criteria
- prurigo nodularis with massive excoriations and/or local infections
- atopic dermatitis, predisposition for atopic dermatitis
- Itch intensity below VAS 4 (visual analoge scale 0 to 10)
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.
- Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. 'Medically approved' contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.
- active psychosomatic and psychiatric diseases
- History of active malignancy of any organ system
- actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc)
- Systemic immunosuppression
- Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry
- current and past (within 2 weeks prior to study entry) systemic use of antihistamines, steroids, cyclosporin A and other immunosuppressants, paroxetin, fluvoxamine (selective serotonin reuptake- inhibitors, study possible in case of medication since 6 months due to depression without having any Antipruritic effect) naltrexone and UV-therapy.
- wound healing disturbances, disposition for keloids, current medication which leads to increased bleeding during procedure e.g. acetylsalicylic acid (ASS), marcumar (no suction blister possible)
- History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream
- Participation in other clinical studies within the last 4 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: PimecrolimusInterindividual design: active and comparator (one side each) applied twice daily |
| II Hydrocortisone | Active comparator | Drug: HydrocortisoneHydrocortisone, twice daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 - 70 years
- Diagnosis: Prurigo nodularis
- Pruritus intensity above VAS 3 (Visual analoge scale 0 to 10)
- Nodules on arms and legs (target areas: arms)
- No effective current external or internal antipruritic medication
Key exclusion criteria (14 listed)
- prurigo nodularis with massive excoriations and/or local infections
- atopic dermatitis, predisposition for atopic dermatitis
- Itch intensity below VAS 4 (visual analoge scale 0 to 10)
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.
- Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. 'Medically approved' contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.
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 |
|---|---|---|
| PimecrolimusAlso: Elidel Cream 1%twice daily topical | Drug | I |
| HydrocortisoneAlso: Hydrocortisone HExaltwice daily topical | Drug | II Hydrocortisone |
| PimecrolimusAlso: Elidel 1% Creamtopical application as a cream twice daily | Drug | I |
Primary outcome
Hypothesis: pimecrolimus is superior in the reduction of the itch intensity on a visual analogue scale (VAS) compared to hydrocortisone cream 1%. H1: mean value VAS pimecrolimus < mean value VAS hydrocortisone
Time frame: 12 months
2 secondary outcomes
Improvement of total symptom score (papule, nodules, excoriations, crusting, erythema) scored from 0-3 for each single symptom
Time frame: 12 months
Change of skin neuropeptide content in suction blisters
Time frame: 12 months
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 7 Jul 2010.
- Background: PubMed 17388925Stander S, Stander H, Seeliger S, Luger TA, Steinhoff M. Topical pimecrolimus and tacrolimus transiently induce neuropeptide release and mast cell degranulation in murine skin. Br J Dermatol. 2007 May;156(5):1020-6. doi: 10.1111/j.1365-2133.2007.07813.x. Epub 2007 Mar 28.
- Background: PubMed 12719860Stander S, Luger TA. [Antipruritic effects of pimecrolimus and tacrolimus]. Hautarzt. 2003 May;54(5):413-7. doi: 10.1007/s00105-003-0521-6. Epub 2003 Mar 21. German.
- Background: PubMed 15488288Senba E, Katanosaka K, Yajima H, Mizumura K. The immunosuppressant FK506 activates capsaicin- and bradykinin-sensitive DRG neurons and cutaneous C-fibers. Neurosci Res. 2004 Nov;50(3):257-62. doi: 10.1016/j.neures.2004.07.005.
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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.
Thomas A Luger, MD principal investigator
Department of Dermatology, University of Münster, Von-Esmarch-Str. 58, D-48149 Münster, Germany
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 Pimecrolimus and Hydrocortisone in people with Prurigo Nodularis, run by University Hospital Muenster 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 6 inclusion and 14 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 7 Jul 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.
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?
Hypothesis: pimecrolimus is superior in the reduction of the itch intensity on a visual analogue scale (VAS) compared to hydrocortisone cream 1%. H1: mean value VAS pimecrolimus < mean value VAS hydrocortisone (time frame: 12 months). 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 NCT00507832, 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 7 Jul 2010.