Topical Application of AS101 for the Treatment of Atopic Dermatitis

NCT ID: NCT00927212

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-09-30

Brief 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.

Detailed 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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

2% AS101 ointment

Group Type: EXPERIMENTAL

AS101 ointment

Intervention Type: DRUG

Twice daily topical application

Group 2

4% AS101 ointment

Group Type: EXPERIMENTAL

AS101 ointment

Intervention Type: DRUG

Twice daily topical application

Interventions

AS101 ointment

Twice daily topical application

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioMAS Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felix Pavlotsky, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Dermatology department, Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

#76 REV 00

Identifier Type: -

Identifier Source: org_study_id