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Investigation of Efficacy and Safety of EPOGAM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Max Zeller Soehne AG
ClinicalTrials.gov Identifier:
NCT00878670
First received: April 8, 2009
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Neurodermatitis
 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.

  Eligibility

Ages Eligible for Study:   2 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878670

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

Publications:

Responsible Party: Max Zeller Soehne AG
ClinicalTrials.gov 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
Dermatitis, Atopic
Neurodermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Efamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013