Topical Application of AS101 for the Treatment of Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild to Moderate Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AS101 Cream

Twice daily topical application of AS101 cream on the psoriatic lesions for approx. 12 weeks is expected to clear the treated area.

Group Type EXPERIMENTAL

AS101 Cream

Intervention Type DRUG

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

Placebo

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

Group Type EXPERIMENTAL

AS101 Cream

Intervention Type DRUG

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

Interventions

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AS101 Cream

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No