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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Page 1 of 1 (1 locations)

1

Dermatology department, Sheba Medical Center

Ramat Gan, Israel

Topical Application of AS101 for the Treatment of Atopic Dermatitis | DecenTrialz