Topical Application of AS101 for the Treatment of Psoriasis

July 22, 2015 updated by: BioMAS Ltd

Study of Topical Application of AS101 for the Treatment of Psoriasis

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks treatment and 3 month follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks treatment and 3 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioMAS Ltd

Investigators

  • Principal Investigator: Arie Ingbar, Prof, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 23, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #72REV00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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