Clinical trial NCT00927212: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: BioMAS Ltd
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Modified SCORAD index
timeFrame: within 6 weeks treatment and 4 weeks follow up
Secondary outcomes:
measure: Remission period
timeFrame: within 4 weeks post treatment completion
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Dermatology department, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Felix Pavlotsky, MD
role: PRINCIPAL_INVESTIGATOR
References: