Back to resultsTopical Application of AS101 for the Treatment of Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
AS101 ointment
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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.
Sites / Locations
- Dermatology department, Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
2% AS101 ointment
4% AS101 ointment
Outcomes
Primary Outcome Measures
Modified SCORAD index
Secondary Outcome Measures
Remission period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00927212
Brief Title
Topical Application of AS101 for the Treatment of Atopic Dermatitis
Official Title
Randomized Double Blind Uncontrolled Pilot Study to Compare 2% and 4% AS101 Ointment for the Treatment of Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
The trial started and halted due sponsor's considerations.
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioMAS Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
2% AS101 ointment
Arm Title
Group 2
Arm Type
Experimental
Arm Description
4% AS101 ointment
Intervention Type
Drug
Intervention Name(s)
AS101 ointment
Intervention Description
Twice daily topical application
Primary Outcome Measure Information:
Title
Modified SCORAD index
Time Frame
within 6 weeks treatment and 4 weeks follow up
Secondary Outcome Measure Information:
Title
Remission period
Time Frame
within 4 weeks post treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Pavlotsky, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology department, Sheba Medical Center
City
Ramat-Gan
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Topical Application of AS101 for the Treatment of Atopic Dermatitis
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