Atopic DermatitisPhase 4NCT00878670
Investigation of Efficacy and Safety of EPOGAM
A Phase 4 study testing EPOGAM 1000 in people with Atopic Dermatitis and Neurodermatitis, run by Max Zeller Soehne AG at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 45 years
- Conditions the study is for
- Atopic Dermatitis, Neurodermatitis
- What is being tested?
- EPOGAM 1000
- Type of treatment
- Pill or oral medicine
- How many people
- 23 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Mar 2009to Oct 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- psychiatric disorder
- abuse of drugs or alcohol
- chronic dermatosis
- glaucoma, cataract or ocular herpes simplex
- Immune deficiency
- Immunological diseases
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Children Clinic, Canton Hospital Aarau
Aarau, Canton of Aargau, 5001
University Hospital Zurich
Zurich, Canton of Zurich, CH-8091
About this study
Official title: Prospective Clinical Trial to Assess the Efficacy and Safety of EPOGAM 1000 in Patients With Atopic Dermatitis (Explorative Pilot Study)
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.
Read the 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.
- Conditions
- Atopic Dermatitis, Neurodermatitis
- Being tested
- EPOGAM 1000
- Medical subject headings
- Dermatitis, Atopic, Neurodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPOGAM 1000Drug
Also called Oenothera seminis oleum, Evening Primrose Oil, EPOGAM
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of dihomo-gamma linolic acid in the blood
Measured: 0, 4 and 12 weeks after start of treatment
Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 weeks after start of treatment
Assessment of the efficacy of EPOGAM treatment by the investigator
Measured: 4 and 12 weeks after start of treatment
Assessment of adverse events (AE)
Measured: During treatment (12 weeks)
Physical examination
Measured: 0, 4 and 12 weeks after start of treatment
Laboratory values (blood examination)
Measured: 0, 4 and 12 weeks after start of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Zeller Soehne AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Grendelmeier, MD, Principal investigator, University Clinic Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878670
- Sponsor's protocol ID
- Ze 358 2008.01
- Status last verified
- Jan 2012
- First submitted
- 8 Apr 2009
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10233322Yoon 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.
PubMed 11803254Simon 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.
PubMed 24435467
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial to Assess the Efficacy and Safety of EPOGAM 1000 in Patients With Atopic Dermatitis (Explorative Pilot Study)
- ClinicalTrials.gov ID
- NCT00878670
- Acronym / sponsor ID
- Ze 358 2008.01
- Conditions
- Atopic Dermatitis, Neurodermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Max Zeller Soehne AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- psychiatric disorder
- abuse of drugs or alcohol
- chronic dermatosis
- glaucoma, cataract or ocular herpes simplex
- Immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPOGAM 1000Also: Oenothera seminis oleum, Evening Primrose Oil, EPOGAMOne 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. | Drug | – |
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Background: PubMed 10233322Henz 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.
- Background: PubMed 11803254Yoon 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.
- Derived from this study: PubMed 24435467Simon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Grendelmeier, MD principal investigator
University Clinic Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EPOGAM 1000 in people with Atopic Dermatitis and Neurodermatitis, run by Max Zeller Soehne AG at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of dihomo-gamma linolic acid in the blood (time frame: 0, 4 and 12 weeks after start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878670, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.