Clinical Trial: Investigation of Efficacy and Safety of EPOGAM

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Max Zeller Soehne AG

Current Primary Outcome:

  • Levels of dihomo-gamma linolic acid in the blood [ Time Frame: 0, 4 and 12 weeks after start of treatment ]
  • Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis [ Time Frame: 0, 4 and 12 weeks after start of treatment ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]
  • Assessment of the efficacy of EPOGAM treatment by the investigator [ Time Frame: 4 and 12 weeks after start of treatment ]
  • Assessment of adverse events (AE) [ Time Frame: During treatment (12 weeks) ]
  • Physical examination [ Time Frame: 0, 4 and 12 weeks after start of treatment ]
  • Laboratory values (blood examination) [ Time Frame: 0, 4 and 12 weeks after start of the treatment ]


Original Secondary Outcome: Same as current

Information By: Max Zeller Soehne AG

Dates:
Date Received: April 8, 2009
Date Started: March 2009
Date Completion:
Last Updated: January 25, 2012
Last Verified: January 2012