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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPOGAM 1000 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Grendelmeier, MD | University Clinic Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Clinic, Canton Hospital Aarau | Aarau | Canton of Aargau | 5001 | Switzerland | ||
| University Hospital Zurich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10233322 | Background | 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. | |
| 11803254 | Background |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D009450 | Neurodermatitis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C028498 | evening primrose oil |
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| 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) |
| Physical examination | 0, 4 and 12 weeks after start of treatment |
| Laboratory values (blood examination) | 0, 4 and 12 weeks after start of the treatment |
| Zurich |
| Canton of Zurich |
| CH-8091 |
| Switzerland |
| 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. |
| 24435467 | Derived | 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. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |