Status:
COMPLETED
Investigation of Efficacy and Safety of EPOGAM
Lead Sponsor:
Max Zeller Soehne AG
Conditions:
Atopic Dermatitis
Neurodermatitis
Eligibility:
All Genders
2-45 years
Phase:
PHASE4
Brief Summary
In this study it will be investigated if patients with atopic dermatitis responding to EPOGAM treatment, show a significant increase of dihomo-gamma-linolic acid in the blood.
Detailed Description
Patients with atopic dermatitis will receive EPOGAM 1000 for 12 weeks. Clinical symptoms of the disease will be assessed using the SCORAD score. Dihomo-gamma-linolic acid levels in the blood will be m...
Eligibility Criteria
Inclusion
- atopic dermatitis since at least 2 months (criteria after Hanifin and Rajka, 1980)
- men or women aged 2 - 45 years
- women of childbearing age using contraception
- informed consent of the patient or of the parents
Exclusion
- psychiatric disorder
- abuse of drugs or alcohol
- chronic dermatosis
- glaucoma, cataract or ocular herpes simplex
- Immune deficiency
- Immunological diseases
- clinical relevant changes in laboratory parameters
- congenital diseases
- scabies, infections with dermathophytae, HIV-associated dermatosis
- malignant diseases
- metabolic diseases
- parasites
- patients enrolled in other studies
- progredient, systemic diseases
- pregnancy and lactation
- severe internistic diseases
- organ transplantation in the medical history
- hypersensitivity against an ingredient of the study medication
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00878670
Start Date
March 1 2009
End Date
October 1 2010
Last Update
January 26 2012
Active Locations (2)
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1
Children Clinic, Canton Hospital Aarau
Aarau, Canton of Aargau, Switzerland, 5001
2
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, CH-8091