Topical Application of AS101 for the Treatment of Psoriasis

Phase 2

Withdrawn

• Conditions: Mild to Moderate Psoriasis
• Interventions: Drug: AS101 Cream

• Registration Number: NCT00788424
• Lead Sponsor: BioMAS Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-06
• Study Start: 2008-11
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AS101 Cream	AS101 Cream	Twice daily topical application of AS101 cream on the psoriatic lesions for approx. 12 weeks is expected to clear the treated area.
Placebo	AS101 Cream	Twice daily topical application on the psoriatic lesions for 8 weeks will serve as control group.

Primary Outcome Measures

Name	Time	Method
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	12 weeks treatment and 3 month follow up

Secondary Outcome Measures

Name	Time	Method
The main secondary endpoints are to evaluate safety, tolerability of topical AS010 treatment and long term remission of psoriasis.	12 weeks treatment and 3 month follow up

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel