Topical Application of AS101 for the Treatment of Atopic Dermatitis

About this trial

Last updated 12 years ago

Study ID

#76 REV 00

Status

Terminated

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 16 years ago

What is this trial about?

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.

What are the participation requirements?

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.