Topical Application of AS101 for the Treatment of Atopic Dermatitis

Phase 2TerminatedNCT00927212

BioMAS Ltd5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

AS101 ointmentDRUG

Twice daily topical application

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed Atopic Dermatitis for at least 6 months prior to enrollment. * Diseased Body surface area (BSA) ≤ 20%. * Male and Female ≥ 18. * Adequate general health. * Signed Informed consent form by the patient or his/her legal guardian. * Patient must be able and willing to comply with all protocol requirements. 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: * Topical corticosteroid within 2 weeks prior to Day 1 visit; * Systemic steroids and immunosuppressants within 1 month prior to Day 1 visit; \*Systemic anti-histamines and antibiotics within 2 weeks prior to Day 1 visit; \*Phototherapy within 4 weeks prior to Day 1 visit; * Anticipated exaggerated exposure to sunlight during the whole treatment period and 4 weeks prior to Day 1 visit.

Locations (1)

Dermatology department, Sheba Medical Center

Ramat Gan, Israel

Outcomes

Primary Outcomes

Modified SCORAD index

Time frame: within 6 weeks treatment and 4 weeks follow up

Secondary Outcomes

Remission period

Time frame: within 4 weeks post treatment completion

Data from ClinicalTrials.gov

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