A Phase 4 interventional study of EPOGAM 1000 in Atopic Dermatitis and Neurodermatitis, sponsored by Max Zeller Soehne AG. Completed at 2 sites in Switzerland. Open to participants aged 2 Years to 45 Years. Per ClinicalTrials.gov, last updated 2012-01-26.
Sponsored by Max Zeller Soehne AG · Phase 4, Interventional, and Treatment
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.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 23 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Max Zeller Soehne AG is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
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The human immunodeficiency virus, which weakens the immune system.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
The record gives a start of Mar 2009, a primary completion of Oct 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Evening primrose oil
Max Zeller Soehne AG