Topical Application of AS101 for the Treatment of Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Randomized Double Blind Uncontrolled Pilot Study to Compare 2% and 4% AS101 Ointment for the Treatment of Atopic Dermatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00927212
• Other study ID #: #76 REV 00
• Status: Terminated
• Phase: Phase 2
• First received: June 23, 2009
• Last updated: July 16, 2014
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2011
• Source: BioMAS Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• AS101 ointment
Twice daily topical application

Locations

Country	Name	City	State
Israel	Dermatology department, Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
BioMAS Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified SCORAD index		within 6 weeks treatment and 4 weeks follow up	No
Secondary	Remission period		within 4 weeks post treatment completion	No

External Links

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