Description:

ODM derived from http://clinicaltrials.gov/show/NCT00507832

Link:

http://clinicaltrials.gov/show/NCT00507832

Keywords:
Versions (2) ▾
  1. 12/10/13
  2. 4/14/14
Uploaded on:

April 14, 2014

DOI:
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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00507832 Prurigo Nodularis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 70 Years
Diagnosis: Prurigo nodularis
Pruritus intensity >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 <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