Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease - Full Text View

Sponsor:	University Hospital Muenster
Collaborator:	Novartis Pharmaceuticals
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00507832

Purpose

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.

Condition	Intervention	Phase
Prurigo Nodularis	Drug: Pimecrolimus Drug: Hydrocortisone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease

Resource links provided by NLM:

MedlinePlus related topics: Itching

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Pimecrolimus Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement of total symptom score (papule, nodules, excoriations, crusting, erythema) scored from 0-3 for each single symptom [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change of skin neuropeptide content in suction blisters [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	April 2007
Study Completion Date:	October 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: I Interindividual design: active and comparator (one side each) applied twice daily	Drug: Pimecrolimus twice daily topical Other Name: Elidel Cream 1% Drug: Pimecrolimus topical application as a cream twice daily Other Name: Elidel 1% Cream
Active Comparator: II Hydrocortisone Hydrocortisone, twice daily	Drug: Hydrocortisone twice daily topical Other Name: Hydrocortisone HExal

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507832

Locations

Germany
Department of Dermtology, University of Münster
Münster, Germany, 48149

Sponsors and Collaborators

University Hospital Muenster

Novartis Pharmaceuticals

Investigators

Principal Investigator:

Thomas A Luger, MD

Department of Dermatology, University of Münster, Von-Esmarch-Str. 58, D-48149 Münster, Germany

More Information

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. Epub 2007 Mar 28.

Stander S, Luger TA. [Antipruritic effects of pimecrolimus and tacrolimus] Hautarzt. 2003 May;54(5):413-7. Epub 2003 Mar 21. German.

Senba 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.

Responsible Party:	University Hospital Münster
ClinicalTrials.gov Identifier:	NCT00507832 History of Changes
Other Study ID Numbers:	SST-Pr-2-2005
Study First Received:	July 26, 2007
Last Updated:	July 6, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:

Prurigo nodularis

Additional relevant MeSH terms:

Prurigo
Neurodermatitis
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Antipruritics
Cortisol succinate
Hydrocortisone acetate
Pimecrolimus
Hydrocortisone
Tacrolimus
Dermatologic Agents
Therapeutic Uses

Pharmacologic Actions
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012