Investigation of Efficacy and Safety of EPOGAM

Prospective Clinical Trial to Assess the Efficacy and Safety of EPOGAM 1000 in Patients With Atopic Dermatitis (Explorative Pilot Study)

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis; Neurodermatitis
• Intervention / Treatment: Drug: EPOGAM 1000

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, CH-8091
    • University Hospital Zurich
  • Argau
    • Aarau, Argau, Switzerland, 5001
      • Children Clinic, Canton Hospital Aarau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 43 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Max Zeller Soehne AG
• Investigators: Principal Investigator: Peter Grendelmeier, MD, University Clinic Zurich

Publications and helpful links

General Publications

• Henz BM, Jablonska S, van de Kerkhof PC, Stingl G, Blaszczyk M, Vandervalk PG, Veenhuizen R, Muggli R, Raederstorff D. Double-blind, multicentre analysis of the efficacy of borage oil in patients with atopic eczema. Br J Dermatol. 1999 Apr;140(4):685-8. doi: 10.1046/j.1365-2133.1999.02771.x.
• Yoon S, Lee J, Lee S. The therapeutic effect of evening primrose oil in atopic dermatitis patients with dry scaly skin lesions is associated with the normalization of serum gamma-interferon levels. Skin Pharmacol Appl Skin Physiol. 2002 Jan-Feb;15(1):20-5. doi: 10.1159/000049385.
• Simon D, Eng PA, Borelli S, Kagi R, Zimmermann C, Zahner C, Drewe J, Hess L, Ferrari G, Lautenschlager S, Wuthrich B, Schmid-Grendelmeier P. Gamma-linolenic acid levels correlate with clinical efficacy of evening primrose oil in patients with atopic dermatitis. Adv Ther. 2014 Feb;31(2):180-8. doi: 10.1007/s12325-014-0093-0. Epub 2014 Jan 17.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: April 8, 2009
• First Submitted That Met QC Criteria: April 8, 2009
• First Posted (Estimate): April 9, 2009

Study Record Updates

• Last Update Posted (Estimate): January 26, 2012
• Last Update Submitted That Met QC Criteria: January 25, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Neurodermatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites; Dermatologic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Evening primrose oil
• Other Study ID Numbers: Ze 358 2008.01