Investigation of Efficacy and Safety of EPOGAM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Clinical Trial to Assess the Efficacy and Safety of EPOGAM 1000 in Patients With Atopic Dermatitis (Explorative Pilot Study)

Conditions
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Atopic Dermatitis, Neurodermatitis

Intervention / Treatment
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* Drug: EPOGAM 1000


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EPOGAM 1000|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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |