Clinical trial NCT00878670: Investigation of Efficacy and Safety of EPOGAM
Official title: Prospective Clinical Trial to Assess the Efficacy and Safety of EPOGAM 1000 in Patients With Atopic Dermatitis (Explorative Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Neurodermatitis
Lead sponsor: Max Zeller Soehne AG
Sponsor class: INDUSTRY
First posted: 2009-04-09
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Levels of dihomo-gamma linolic acid in the blood
timeFrame: 0, 4 and 12 weeks after start of treatment
measure: Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis
timeFrame: 0, 4 and 12 weeks after start of treatment
Secondary outcomes:
measure: Assessment of the efficacy of EPOGAM 1000 treatment by the patient on a visual analog scale
timeFrame: 4 and 12 weeks after start of treatment
measure: Assessment of the symptoms itching, sleep disorder, skin sensation, skin condition by the patient on a visual analog scale
timeFrame: 4 and 12 weeks after start of treatment
measure: Willingness of the patient to further take the medication and assessment of problems related to the intake of the study drug.
timeFrame: 12 weeks after start of treatment
measure: Assessment of the efficacy of EPOGAM treatment by the investigator
timeFrame: 4 and 12 weeks after start of treatment
measure: Assessment of adverse events (AE)
timeFrame: During treatment (12 weeks)
measure: Physical examination
timeFrame: 0, 4 and 12 weeks after start of treatment
measure: Laboratory values (blood examination)
timeFrame: 0, 4 and 12 weeks after start of the treatment
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Children Clinic, Canton Hospital Aarau
state: Argau
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Clinic Zurich
name: Peter Grendelmeier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.