Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topical Application of AS101 for the Treatment of Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00788424
Recruitment Status : Withdrawn (Sponsor's considerations)
First Posted : November 11, 2008
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
BioMAS Ltd

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This protocol relates to a phase II randomized double blind, placebo controlled study of the AS101 topical application for the treatment of mild to moderate Psoriasis.

Condition or disease Intervention/treatment Phase
Mild to Moderate Psoriasis Drug: AS101 Cream Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of Topical Application of AS101 for the Treatment of Psoriasis
Study Start Date : November 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: AS101 Cream
Twice daily topical application of AS101 cream on the psoriatic lesions for approx. 12 weeks is expected to clear the treated area.
 Drug: AS101 Cream
4% AS101 Cream or Placebo cream, twice a day for 12 weeks
Experimental: Placebo
Twice daily topical application on the psoriatic lesions for 8 weeks will serve as control group.
 Drug: AS101 Cream
4% AS101 Cream or Placebo cream, twice a day for 12 weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To evaluate the percentege of patients in which modified PASI (mPASI) score reduction of more than 66% from Baseline whithin 12-week treatment period is achieved [ Time Frame: 12 weeks treatment and 3 month follow up ]

Secondary Outcome Measures :
  1. The main secondary endpoints are to evaluate safety, tolerability of topical AS010 treatment and long term remission of psoriasis. [ Time Frame: 12 weeks treatment and 3 month follow up ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient have a diagnosed mild to moderate stable plaque type psoriasis (less than 10% of body skin surface).
  2. Patient must be 18-70 years of age.
  3. General health must be adequate to allow for compliance with the requirements of this protocol.
  4. Patient or his/her legal guardian must sign an informed consent form prior to study participation.
  5. Patient must be able and willing to comply with all protocol requirements.

Exclusion Criteria:

  1. Patients who are mentally disabled or are otherwise unable to provide fully informed consent.
  2. Pregnant or breast-feeding females.
  3. Patients with evidence of an infection in the targeted zones.
  4. Patients with known sensitivity to any of the drug components.
  5. Patients treated by systemic anti psoriatic medications within one month prior to the initial treatment with the AS101, or topical anti psoriatic preparations within two weeks prior to the initial treatment with the AS101.
  6. Patient with psoriatic arthritis.
  7. Patients taking immunosuppressive drugs.
  8. Immunocompromised patients
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788424


Locations
Layout table for location information
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
BioMAS Ltd
Investigators
Layout table for investigator information
Principal Investigator: Arie Ingbar, Prof Hadassah Medical Organization
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: BioMAS Ltd
ClinicalTrials.gov Identifier: NCT00788424    
Other Study ID Numbers: #72REV00
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: June 2008
Keywords provided by BioMAS Ltd:
AS101 Psoriasis
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Radiation-Protective Agents
Protective Agents