Topical Application of AS101 for the Treatment of Atopic Dermatitis

Randomized Double Blind Uncontrolled Pilot Study to Compare 2% and 4% AS101 Ointment for the Treatment of Atopic Dermatitis

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.

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: AS101 ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Ramat-Gan, Israel
    • Dermatology department, Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 2% AS101 ointment	Drug: AS101 ointment; Twice daily topical application
Experimental: Group 2; 4% AS101 ointment	Drug: AS101 ointment; Twice daily topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified SCORAD index	within 6 weeks treatment and 4 weeks follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Remission period	within 4 weeks post treatment completion

Collaborators and Investigators

• Sponsor: BioMAS Ltd
• Investigators: Principal Investigator: Felix Pavlotsky, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: June 23, 2009
• First Submitted That Met QC Criteria: June 23, 2009
• First Posted (Estimate): June 24, 2009

Study Record Updates

• Last Update Posted (Estimate): July 17, 2014
• Last Update Submitted That Met QC Criteria: July 16, 2014
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Radiation-Protective Agents; Ammonium trichloro(dioxoethylene-O,O'-)tellurate
• Other Study ID Numbers: #76 REV 00