Eligibility NCT00507832 Prurigo Nodularis Inclusion Criteria Exclusion Criteria prurigo nodularis with massive excoriations and/or local infections Yes
No
atopic dermatitis, predisposition for atopic dermatitis Yes
No
Itch intensity <VAS 4 (visual analoge scale 0 to 10) Yes
No
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. Yes
No
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. Yes
No
active psychosomatic and psychiatric diseases Yes
No
History of active malignancy of any organ system Yes
No
actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc) Yes
No
Systemic immunosuppression Yes
No
Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry Yes
No
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. Yes
No
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) Yes
No
History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream Yes
No
Participation in other clinical studies within the last 4 weeks Yes
No
