NCT00878670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

1.6 years

First QC Date

April 8, 2009

Last Update Submit

January 25, 2012

Conditions

Atopic DermatitisNeurodermatitis

Outcome Measures

Primary Outcomes (2)

  • Levels of dihomo-gamma linolic acid in the blood

    0, 4 and 12 weeks after start of treatment

  • Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis

    0, 4 and 12 weeks after start of treatment

Secondary Outcomes (7)

  • Assessment of the efficacy of EPOGAM 1000 treatment by the patient on a visual analog scale

    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

    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.

    12 weeks after start of treatment

  • Assessment of the efficacy of EPOGAM treatment by the investigator

    4 and 12 weeks after start of treatment

  • Assessment of adverse events (AE)

    During treatment (12 weeks)

  • +2 more secondary outcomes

Interventions

EPOGAM 1000DRUG

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.

Also known as: Oenothera seminis oleum, Evening Primrose Oil, EPOGAM

Eligibility Criteria

Age2 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children Clinic, Canton Hospital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

University Hospital Zurich

Zurich, Canton of Zurich, CH-8091, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 10233322BACKGROUND

  • 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.

    PMID: 11803254BACKGROUND

  • 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.

    PMID: 24435467DERIVED

MeSH Terms

Conditions

Dermatitis, AtopicNeurodermatitis

Interventions

evening primrose oil

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Peter Grendelmeier, MD

    University Clinic Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 9, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

CH(2)