Topical Application of AS101 for the Treatment of Psoriasis

BioMAS

Status and phase: Withdrawn; Phase 2

Conditions: Mild to Moderate Psoriasis

Treatments: Drug: AS101 Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00788424

#72REV00

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

AS101 Cream

Experimental group

Description:

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

Treatment:

Drug: AS101 Cream

Placebo

Experimental group

Description:

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

Treatment:

Drug: AS101 Cream