Topical Application of AS101 for the Treatment of Atopic Dermatitis

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMAS Ltd
• Treatments: Ammonium trichloro(dioxoethylene-O,O'-)tellurate

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.