Topical Application of AS101 for the Treatment of Psoriasis

NCT00788424 | Withdrawn Phase 2

• 1 other identifier: #72REV00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Psoriasis

Keywords

AS101 Psoriasis

Outcome Measures

Primary Outcomes (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

  12 weeks treatment and 3 month follow up

Secondary Outcomes (1)

• 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

Study Arms (2)

AS101 Cream

EXPERIMENTAL

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

Placebo

EXPERIMENTAL

Twice daily topical application on the psoriatic lesions for 8 weeks will serve as control group.

Drug: AS101 Cream

Interventions

AS101 Cream DRUG

4% AS101 Cream or Placebo cream, twice a day for 12 weeks

AS101 Cream; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BioMAS Ltd: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Study Officials

• Arie Ingbar, Prof

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 23, 2015

Record last verified: 2008-06

Locations

IL (1)