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The trial started and halted due sponsor's considerations.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 2% AS101 ointment |
|
| Group 2 | Experimental | 4% AS101 ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AS101 ointment | Drug | Twice daily topical application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified SCORAD index | within 6 weeks treatment and 4 weeks follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Remission period | within 4 weeks post treatment completion |
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Inclusion Criteria:
Exclusion Criteria:
Patient who is unable to provide fully informed consent.
Pregnant of breast-feeding females.
Concomitant dermatologic or medical condition(s) which may interfere with the patient's response evaluation.
Evidence of an infection in the targeted zones.
Known sensitivity to any of the drug component.
Immunocompromised patients.
Concomitant medications such as:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Pavlotsky, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology department, Sheba Medical Center | Ramat Gan | Israel |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |