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

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

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