Investigation of Efficacy and Safety of EPOGAM

Max Zeller Söhne

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis; Neurodermatitis

Treatments: Drug: EPOGAM 1000

Study type: Interventional

Funder types: Industry

Identifiers

NCT00878670

Ze 358 2008.01

Details and patient eligibility

About

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.

Full 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 measured with GC-MS.

Enrollment: 23 patients

Sex: All

Ages: 2 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)