Investigation of Efficacy and Safety of EPOGAM

Phase 4

Completed

• Conditions: Atopic Dermatitis; Neurodermatitis

• Registration Number: NCT00878670
• Lead Sponsor: Max Zeller Soehne AG

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 measured with GC-MS.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-08
• Study First Submitted QC: 2009-04-08
• Study First Posted: 2009-04-09
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-25
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Levels of dihomo-gamma linolic acid in the blood	0, 4 and 12 weeks after start of treatment
Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis	0, 4 and 12 weeks after start of treatment

Secondary Outcome Measures

Name	Time	Method
Assessment of the efficacy of EPOGAM 1000 treatment by the patient on a visual analog scale	4 and 12 weeks after start of treatment
Assessment of the symptoms itching, sleep disorder, skin sensation, skin condition by the patient on a visual analog scale	4 and 12 weeks after start of treatment
Willingness of the patient to further take the medication and assessment of problems related to the intake of the study drug.	12 weeks after start of treatment
Assessment of the efficacy of EPOGAM treatment by the investigator	4 and 12 weeks after start of treatment
Assessment of adverse events (AE)	During treatment (12 weeks)
Physical examination	0, 4 and 12 weeks after start of treatment
Laboratory values (blood examination)	0, 4 and 12 weeks after start of the treatment

Trial Locations

Locations (2)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland

Children Clinic, Canton Hospital Aarau; 🇨🇭 Aarau, Argau, Switzerland