Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease (CASM981CDE21)

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00507832
First received: July 26, 2007
Last updated: July 6, 2010
Last verified: February 2009
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Hydrocortisone 17-butyrate 21-propionate
Pimecrolimus
Hydrocortisone
Hydrocortisone-17-butyrate
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 July 24, 2014