Topical Application of AS101 for the Treatment of Psoriasis

This study has been withdrawn prior to enrollment.
(Sponsor's considerations)
Sponsor:
Information provided by:
BioMAS Ltd
ClinicalTrials.gov Identifier:
NCT00788424
First received: November 10, 2008
Last updated: June 19, 2011
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Mild to Moderate Psoriasis
Drug: AS101 Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Topical Application of AS101 for the Treatment of Psoriasis

Resource links provided by NLM:


Further study details as provided by BioMAS Ltd:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 weeks treatment and 3 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The main secondary endpoints are to evaluate safety, tolerability of topical AS010 treatment and long term remission of psoriasis. [ Time Frame: 12 weeks treatment and 3 month follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AS101 Cream
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
4% AS101 Cream or Placebo cream, twice a day for 12 weeks
Experimental: Placebo
Twice daily topical application on the psoriatic lesions for 8 weeks will serve as control group.
Drug: AS101 Cream
4% AS101 Cream or Placebo cream, twice a day for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788424

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
BioMAS Ltd
Investigators
Principal Investigator: Arie Ingbar, Prof Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Reuven Ron, CEO, BioMas Ltd
ClinicalTrials.gov Identifier: NCT00788424     History of Changes
Other Study ID Numbers: #72REV00
Study First Received: November 10, 2008
Last Updated: June 19, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by BioMAS Ltd:
AS101 Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 19, 2014