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Completed

NCT Number: NCT00878670

Investigation of Efficacy and Safety of EPOGAM

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Neurodermatitis Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children Clinic, Canton Hospital Aarau, Aarau, Canton of Aargau, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPOGAM 1000

Drug

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

Primary outcomes

  1. Levels of dihomo-gamma linolic acid in the blood

    Time frame: 0, 4 and 12 weeks after start of treatment

  2. Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis

    Time frame: 0, 4 and 12 weeks after start of treatment

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Assessment of the efficacy of EPOGAM treatment by the investigator

    Time frame: 4 and 12 weeks after start of treatment

  5. Assessment of adverse events (AE)

    Time frame: During treatment (12 weeks)

  6. Physical examination

    Time frame: 0, 4 and 12 weeks after start of treatment

  7. Laboratory values (blood examination)

    Time frame: 0, 4 and 12 weeks after start of the treatment

Sponsors and collaborators

Lead sponsor

Max Zeller Soehne AG

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 9, 2009
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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