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

Sponsor

University Hospital Muenster (Other)

Overall Status

Completed

CT.gov ID

NCT00507832

Collaborator

Novartis Pharmaceuticals (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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 or Disease	Intervention/Treatment	Phase
Prurigo Nodularis	Drug: Pimecrolimus Drug: Hydrocortisone Drug: Pimecrolimus	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: I Interindividual design: active and comparator (one side each) applied twice daily	Drug: Pimecrolimus twice daily topical Other Names: Elidel Cream 1% Drug: Pimecrolimus topical application as a cream twice daily Other Names: Elidel 1% Cream
Active Comparator: II Hydrocortisone Hydrocortisone, twice daily	Drug: Hydrocortisone twice daily topical Other Names: Hydrocortisone HExal

Arm

Intervention/Treatment

Active Comparator: I

Interindividual design: active and comparator (one side each) applied twice daily

Drug: Pimecrolimus

twice daily topical

Other Names:

Elidel Cream 1%

Drug: Pimecrolimus

topical application as a cream twice daily

Other Names:

Elidel 1% Cream

Active Comparator: II Hydrocortisone

Hydrocortisone, twice daily

Drug: Hydrocortisone

twice daily topical

Other Names:

Hydrocortisone HExal

Outcome Measures

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 [12 months]

Secondary Outcome Measures

Improvement of total symptom score (papule, nodules, excoriations, crusting, erythema) scored from 0-3 for each single symptom [12 months]
Change of skin neuropeptide content in suction blisters [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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