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Investigation of Efficacy and Safety of EPOGAM

Primary Purpose

Atopic Dermatitis, Neurodermatitis

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
EPOGAM 1000
Sponsored by
Max Zeller Soehne AG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

2 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children Clinic, Canton Hospital Aarau
  • University Hospital Zurich

Outcomes

Primary Outcome Measures

Levels of dihomo-gamma linolic acid in the blood
Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis

Secondary Outcome Measures

Assessment of the efficacy of EPOGAM 1000 treatment by the patient on a visual analog scale
Assessment of the symptoms itching, sleep disorder, skin sensation, skin condition by the patient on a visual analog scale
Willingness of the patient to further take the medication and assessment of problems related to the intake of the study drug.
Assessment of the efficacy of EPOGAM treatment by the investigator
Assessment of adverse events (AE)
Physical examination
Laboratory values (blood examination)

Full Information

First Posted
April 8, 2009
Last Updated
January 25, 2012
Sponsor
Max Zeller Soehne AG
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1. Study Identification

Unique Protocol Identification Number
NCT00878670
Brief Title
Investigation of Efficacy and Safety of EPOGAM
Official Title
Prospective Clinical Trial to Assess the Efficacy and Safety of EPOGAM 1000 in Patients With Atopic Dermatitis (Explorative Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Max Zeller Soehne AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Neurodermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EPOGAM 1000
Other Intervention Name(s)
Oenothera seminis oleum, Evening Primrose Oil, EPOGAM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Levels of dihomo-gamma linolic acid in the blood
Time Frame
0, 4 and 12 weeks after start of treatment
Title
Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis
Time Frame
0, 4 and 12 weeks after start of treatment
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Assessment of the efficacy of EPOGAM treatment by the investigator
Time Frame
4 and 12 weeks after start of treatment
Title
Assessment of adverse events (AE)
Time Frame
During treatment (12 weeks)
Title
Physical examination
Time Frame
0, 4 and 12 weeks after start of treatment
Title
Laboratory values (blood examination)
Time Frame
0, 4 and 12 weeks after start of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Grendelmeier, MD
Organizational Affiliation
University Clinic Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children Clinic, Canton Hospital Aarau
City
Aarau
State/Province
Argau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
10233322
Citation
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.
Results Reference
background
PubMed Identifier
11803254
Citation
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.
Results Reference
background
PubMed Identifier
24435467
Citation
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.
Results Reference
derived

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Investigation of Efficacy and Safety of EPOGAM

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