Investigation of Efficacy and Safety of EPOGAM

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878670
• Other study ID #: Ze 358 2008.01
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2009
• Last updated: January 25, 2012
• Start date: March 2009
• Est. completion date: October 2010

Study information

• Verified date: January 2012
• Source: Max Zeller Soehne AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Neurodermatitis

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Children Clinic, Canton Hospital Aarau	Aarau	Argau
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Max Zeller Soehne AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of dihomo-gamma linolic acid in the blood		0, 4 and 12 weeks after start of treatment	No
Primary	Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis		0, 4 and 12 weeks after start of treatment	No
Secondary	Assessment of the efficacy of EPOGAM 1000 treatment by the patient on a visual analog scale		4 and 12 weeks after start of treatment	No
Secondary	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	No
Secondary	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	No
Secondary	Assessment of the efficacy of EPOGAM treatment by the investigator		4 and 12 weeks after start of treatment	No
Secondary	Assessment of adverse events (AE)		During treatment (12 weeks)	Yes
Secondary	Physical examination		0, 4 and 12 weeks after start of treatment	Yes
Secondary	Laboratory values (blood examination)		0, 4 and 12 weeks after start of the treatment	Yes