Back to resultsTopical Application of AS101 for the Treatment of Psoriasis
Primary Purpose
Mild to Moderate Psoriasis
Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
AS101 Cream
Sponsored by
About this trial
This is an interventional treatment trial for Mild to Moderate Psoriasis focused on measuring AS101 Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Patient have a diagnosed mild to moderate stable plaque type psoriasis (less than 10% of body skin surface).
- Patient must be 18-70 years of age.
- General health must be adequate to allow for compliance with the requirements of this protocol.
- Patient or his/her legal guardian must sign an informed consent form prior to study participation.
- Patient must be able and willing to comply with all protocol requirements.
Exclusion Criteria:
- Patients who are mentally disabled or are otherwise unable to provide fully informed consent.
- Pregnant or breast-feeding females.
- Patients with evidence of an infection in the targeted zones.
- Patients with known sensitivity to any of the drug components.
- 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.
- Patient with psoriatic arthritis.
- Patients taking immunosuppressive drugs.
- Immunocompromised patients
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AS101 Cream
Placebo
Arm Description
Twice daily topical application of AS101 cream on the psoriatic lesions for approx. 12 weeks is expected to clear the treated area.
Twice daily topical application on the psoriatic lesions for 8 weeks will serve as control group.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The main secondary endpoints are to evaluate safety, tolerability of topical AS010 treatment and long term remission of psoriasis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00788424
Brief Title
Topical Application of AS101 for the Treatment of Psoriasis
Official Title
Study of Topical Application of AS101 for the Treatment of Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor's considerations
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioMAS Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Psoriasis
Keywords
AS101 Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AS101 Cream
Arm Type
Experimental
Arm Description
Twice daily topical application of AS101 cream on the psoriatic lesions for approx. 12 weeks is expected to clear the treated area.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Twice daily topical application on the psoriatic lesions for 8 weeks will serve as control group.
Intervention Type
Drug
Intervention Name(s)
AS101 Cream
Intervention Description
4% AS101 Cream or Placebo cream, twice a day for 12 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient have a diagnosed mild to moderate stable plaque type psoriasis (less than 10% of body skin surface).
Patient must be 18-70 years of age.
General health must be adequate to allow for compliance with the requirements of this protocol.
Patient or his/her legal guardian must sign an informed consent form prior to study participation.
Patient must be able and willing to comply with all protocol requirements.
Exclusion Criteria:
Patients who are mentally disabled or are otherwise unable to provide fully informed consent.
Pregnant or breast-feeding females.
Patients with evidence of an infection in the targeted zones.
Patients with known sensitivity to any of the drug components.
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.
Patient with psoriatic arthritis.
Patients taking immunosuppressive drugs.
Immunocompromised patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Ingbar, Prof
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Topical Application of AS101 for the Treatment of Psoriasis
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