Prurigo nodularis MedDRA version: 8.1 Level: LLT Classification code 10037084 Term: Prurigo nodularis
Conditions
Interventions
Trade Name: Elidel 1% Cream
Product Name: Elidel 1%
Pharmaceutical Form: Cream
INN or Proposed INN: PIMECROLIMUS
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-
Trade
Sponsors
University of Münster
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective To confirm the efficacy of pimecrolimus cream 1% in patients with prurigo nodularis, by testing the hypothesis that pimecrolimus cream 1% is superior in the reduction of the intensity of the itch on a visual analogue scale (VAS) within the first 10 days of treatment compared to hydrocortisone cream 1%. The visual analog scale from 0 (no pruritus) to 10 (most severe pruritus) is 10 cm (Each itch intensity point is one centimeter). The VAS data will be evaluated by reduction of mean values. It is expected that the mean value of VAS is reduced after treatment with pimecrolimus in comparison to pre-treatment value and in comparison to treatment with hydrocortisone. The data will be statistically evaluated by t-test. H1: mean value VASpimecrolimus < mean value VAShydrocortisone ;Secondary Objective: To investigate the total symptom score (papule, nodules, excoriations, crusting, erythema) scored from 0-3 for each single symptom. To investigate the antipruritic effect of pimecrolimus 1% cream and hydrocortisone cream by measurement of the neuropeptides substance P and calcitonin gene- related peptide in suction blisters. The neuropeptides are expected to be down-regulated by the treatment of pimecrolimus but not hydrocortisone. ;Primary end point(s): 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. | — |
Countries
Germany
Outcome results
None listed