Status:
TERMINATED
Topical Application of AS101 for the Treatment of Atopic Dermatitis
Lead Sponsor:
BioMAS Ltd
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00927212
Start Date
June 1 2009
End Date
September 1 2010
Last Update
July 17 2014
Active Locations (1)
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1
Dermatology department, Sheba Medical Center
Ramat Gan, Israel