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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Page 1 of 1 (2 locations)

1

Children Clinic, Canton Hospital Aarau

Aarau, Canton of Aargau, Switzerland, 5001

2

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland, CH-8091