Topical Application of AS101 for the Treatment of Atopic Dermatitis
Summary
Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for the treatment of Atopic dermatitis.
Description
Atopic dermatitis (AD) is the most common chronic inflammatory skin disease, affecting 10-20% of children and 2% of adults worldwide. The mechanism of AD is still not completely understood, but the disorder appears to result from the complex interaction between immunological responses, various susceptability genes, defects in skin barrier function, host and environmental factors and infectious agents. AS101 is a non toxic potent immunomodulator that has been shown to have beneficial effects in diverse pre clinical and clinical studies. Recently, AS101 has shown efficacy and safety in the treatment of mild to moderate Psoriasis which shares with AD a related immunological mechanism along with the AS101 ability to decrease the level of interleukins known to be involved ith the pathogenesis of AD.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Atopic Dermatitis
Intervention
AS101 ointment
Location
Dermatology department, Sheba Medical Center
Ramat-Gan
Israel
Status
Not yet recruiting
Source
BioMAS Ltd
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00927212
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Kaposi Varicelliform Eruption
A disseminated vesicular-pustular eruption caused by the herpes simplex virus (HERPESVIRUS HOMINIS), the VACCINIA VIRUS, or Varicella zoster (HERPESVIRUS 3, HUMAN). It is usually superimposed on a preexisting, inactive or active, atopic dermatitis (DERMATITIS, ATOPIC).
Dermatitis, Exfoliative
The widespread involvement of the skin by a scaly, erythematous dermatitis occurring either as a secondary or reactive process to an underlying cutaneous disorder (e.g., atopic dermatitis, psoriasis, etc.), or as a primary or idiopathic disease. It is often associated with the loss of hair and nails, hyperkeratosis of the palms and soles, and pruritus. (From Dorland, 27th ed)
Antigens, Dermatophagoides
Antigens from the house dust mites (DERMATOPHAGOIDES), mainly D. farinae and D. pteronyssinus. They are proteins, found in mite feces or mite extracts, that can cause ASTHMA and other allergic diseases such as perennial rhinitis (RHINITIS, ALLERGIC, PERENNIAL) and atopic dermatitis (DERMATITIS, ATOPIC). More than 11 groups of Dermatophagoides ALLERGENS have been defined. Group I allergens, such as Der f I and Der p I from the above two species, are among the strongest mite immunogens in humans.
Netherton Syndrome
Rare autosomal recessive disease with variable expressions. Clinical features of the disease include variable ICHTHYOSIFORM ERYTHRODERMA, CONGENITAL; bamboo hair (trichorrhexis invaginata); and ATOPIC DERMATITIS. The disease is caused by mutations in the SPINK5 gene.
Dermatitis, Atopic
A chronic inflammatory genetically determined disease of the skin marked by increased ability to form reagin (IgE), with increased susceptibility to allergic rhinitis and asthma, and hereditary disposition to a lowered threshold for pruritus. It is manifested by lichenification, excoriation, and crusting, mainly on the flexural surfaces of the elbow and knee. In infants it is known as infantile eczema.
Clinical Trials
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