Prednisolone vs. Ciclosporine in Severe Atopic Eczema. PROVE - Study - PROVE
- Conditions
- atopic eczemaMedDRA version: 8.1Level: LLTClassification code 10003641Term: Atopic eczema
- Registration Number
- EUCTR2006-003667-31-DE
- Lead Sponsor
- Medical Faculty, TU Dresden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- age 18-55 years
- weight 50 -100 kg
- severe atopic eczema (oSCORAD > 40 Punkte, resistant to topical treatment)
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)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- pregnancy / nursing mothers
- Women in reproductive age without adequate contraception
- acute infection (bacterial / viral)
- malignancy in personal history
- concommitant diabetes mellitus, hypertension, glaucoma, osteoporosis, ulcus ventriculi / duodeni, chronic hepatitis B, severe hepatopathy, AND/OR nephropathy,
- UV-Therapy in past 8 weeks
- alcohol AND/OR drug abuse
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to study the comparative efficacy of systemic prednisolone versus ciclosporine in adults with severe atopic eczema<br><br>;Secondary Objective: secondary objectives are changes in quality of life, work productivity, symptoms, and tolerability in both treatment groups;Primary end point(s): proportion of patients with stable response
- Secondary Outcome Measures
Name Time Method