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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:

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 ef
    Sponsor: University Hospital Muenster

    Current 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 ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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 ]


    Original Secondary Outcome: Same as current

    Information By: University Hospital Muenster

    Dates:
    Date Received: July 26, 2007
    Date Started: April 2007
    Date Completion:
    Last Updated: July 6, 2010
    Last Verified: February 2009