Evaluation of the antipruritic effect of Elidel (pimecrolimus) in non-atopic pruritic disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
•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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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