Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease
Condition: Prurigo Nodularis
MeSH terms: Prurigo
Study type: Interventional
Phase: Phase 2

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 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
    

Intervention name(s): Pimecrolimus; Hydrocortisone; Pimecrolimus
Intervention type(s): Drug; Drug; Drug
Intervention description(s): twice daily topical; twice daily topical; topical application as a cream twice daily
Other intervention name(s): Elidel Cream 1%; Hydrocortisone HExal; Elidel 1% Cream
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Pimecrolimus; Tacrolimus
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Prurigo nodularis