Topical Application of AS101 for the Treatment of Atopic Dermatitis

This study has been terminated.
(The trial started and halted due sponsor's considerations.)
Sponsor:
Information provided by (Responsible Party):
BioMAS Ltd
ClinicalTrials.gov Identifier:
NCT00927212
First received: June 23, 2009
Last updated: July 16, 2014
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: AS101 ointment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Uncontrolled Pilot Study to Compare 2% and 4% AS101 Ointment for the Treatment of Atopic Dermatitis

Further study details as provided by BioMAS Ltd:

Primary Outcome Measures:
  • Modified SCORAD index [ Time Frame: within 6 weeks treatment and 4 weeks follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission period [ Time Frame: within 4 weeks post treatment completion ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
2% AS101 ointment
Drug: AS101 ointment
Twice daily topical application
Experimental: Group 2
4% AS101 ointment
Drug: AS101 ointment
Twice daily topical application

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927212

Locations
Israel
Dermatology department, Sheba Medical Center
Ramat-Gan, Israel
Sponsors and Collaborators
BioMAS Ltd
Investigators
Principal Investigator: Felix Pavlotsky, MD Sheba Medical Center, Israel.
  More Information

Additional Information:
No publications provided

Responsible Party: BioMAS Ltd
ClinicalTrials.gov Identifier: NCT00927212     History of Changes
Other Study ID Numbers: #76 REV 00
Study First Received: June 23, 2009
Last Updated: July 16, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 24, 2014