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Topical Application of AS101 for the Treatment of Psoriasis

Study of Topical Application of AS101 for the Treatment of Psoriasis

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00788424
Enrollment
0
Registered
2008-11-11
Start date
2008-11-30
Completion date
2010-02-28
Last updated
2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Psoriasis

Keywords

AS101 Psoriasis

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.

Interventions

DRUGAS101 Cream

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

Sponsors

BioMAS Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 achieved12 weeks treatment and 3 month follow up

Secondary

MeasureTime frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026