Investigation of Efficacy and Safety of EPOGAM

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Max Zeller Soehne AG
• Treatments: Efamol; Evening primrose oil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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