Investigation of Efficacy and Safety of EPOGAM

Max Zeller Soehne AG23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis Neurodermatitis

Interventions

EPOGAM 1000DRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

Children Clinic, Canton Hospital Aarau

Aarau, Canton of Aargau, Switzerland

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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