Investigation of Efficacy and Safety of EPOGAM

This study has been completed.
Information provided by (Responsible Party):
Max Zeller Soehne AG Identifier:
First received: April 8, 2009
Last updated: January 25, 2012
Last verified: January 2012

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.

Condition Intervention Phase
Atopic Dermatitis
Drug: EPOGAM 1000
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Clinical Trial to Assess the Efficacy and Safety of EPOGAM 1000 in Patients With Atopic Dermatitis (Explorative Pilot Study)

Further study details as provided by Max Zeller Soehne AG:

Primary Outcome Measures:
  • Levels of dihomo-gamma linolic acid in the blood [ Time Frame: 0, 4 and 12 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis [ Time Frame: 0, 4 and 12 weeks after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the efficacy of EPOGAM 1000 treatment by the patient on a visual analog scale [ Time Frame: 4 and 12 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Assessment of the symptoms itching, sleep disorder, skin sensation, skin condition by the patient on a visual analog scale [ Time Frame: 4 and 12 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Willingness of the patient to further take the medication and assessment of problems related to the intake of the study drug. [ Time Frame: 12 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Assessment of the efficacy of EPOGAM treatment by the investigator [ Time Frame: 4 and 12 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Assessment of adverse events (AE) [ Time Frame: During treatment (12 weeks) ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: 0, 4 and 12 weeks after start of treatment ] [ Designated as safety issue: Yes ]
  • Laboratory values (blood examination) [ Time Frame: 0, 4 and 12 weeks after start of the treatment ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: March 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: EPOGAM 1000
    One capsule of EPOGAM 1000 contains 932-1073 mg Oenothera seminis oleum, equivalent to 80 mg gamma-linolic acid. Children (2-12 years) take 2 capsules in the morning and evening, whereas persons over 12 years take 3 capsules in the morning and evening. The duration of the treatment is 12 weeks.
    Other Names:
    • Oenothera seminis oleum
    • Evening Primrose Oil
    • EPOGAM
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.


Ages Eligible for Study:   2 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00878670

Children Clinic, Canton Hospital Aarau
Aarau, Argau, Switzerland, 5001
University Hospital Zurich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Max Zeller Soehne AG
Principal Investigator: Peter Grendelmeier, MD University Clinic Zurich
  More Information

Responsible Party: Max Zeller Soehne AG Identifier: NCT00878670     History of Changes
Other Study ID Numbers: Ze 358 2008.01
Study First Received: April 8, 2009
Last Updated: January 25, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents
Central Nervous System Agents processed this record on April 17, 2014