Description:

ODM derived from http://clinicaltrials.gov/show/NCT00445081

Link:

http://clinicaltrials.gov/show/NCT00445081

Keywords:
Versions (2) ▾
  1. 12/9/13
  2. 4/15/14
Uploaded on:

April 15, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00445081 Atopic Dermatitis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age >= 18 and < 55
Body weight (observable entity)
confirmed diagnosis of AE (UK working party criteria)
objective SCORAD > 40
DLQI > 10
resistancy against topical treatment options including steroids and calcineurin-inhibitors
Exclusion Criteria
participation to another clinical trial within the last 4 weeks before baseline
pregnant or breastfeeding
women of childbearing potential without adequate contraception
allergy against prednisolone or Ciclosporine A
acute bacterial or viral infection
History of neoplastic disease
Diabetes mellitus
Hypertensive disease, High Blood Pressure
Glaucoma
Peptic Ulcer
Severe osteoporosis
Personal history of tuberculosis
Ulcerative colitis (UC), Colitis ulcerative
Diverticulitis
concurrent treatment with chloroquin, Mefloquin, Statins, Warafin
Creatinine clearance (CrCl) measurement
UV treatment within 8 weeks before inclusion
ongoing systemic immunosuppressive treatment
planned vaccination within 8 weeks before study entry, during study and 2 weeks after end of study
POLIOMYELITIS
Lymphadenitis after BCG vaccination
Hyperuricemia
Chronic liver disease
Xeroderma pigmentosum, Cockaye-Syndrome, Bloom Syndrome
Psychiatric co-morbidity
drug or alcohol abuse