Atopic Dermatitis, Neurodermatitis
Conditions
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.
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.
Interventions
DRUGEPOGAM 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.
Sponsors
Max Zeller Soehne AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 the efficacy of EPOGAM 1000 treatment by the patient on a visual analog scale | 4 and 12 weeks after start of treatment |
| 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 |
| Assessment of adverse events (AE) | During treatment (12 weeks) |
| 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 |
Countries
Switzerland
Outcome results
None listed