Topical Application of AS101 for the Treatment of Psoriasis

Mild to Moderate Psoriasis Clinical Trial

Official title:

Study of Topical Application of AS101 for the Treatment of Psoriasis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00788424
• Other study ID #: #72REV00
• Status: Withdrawn
• Phase: Phase 2
• First received: November 10, 2008
• Last updated: July 22, 2015
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: June 2008
• Source: BioMAS Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mild to Moderate Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
BioMAS Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes