Mild to Moderate PsoriasisPhase 2NCT00788424
Topical Application of AS101 for the Treatment of Psoriasis
A Phase 2 study testing AS101 Cream in people with Mild to Moderate Psoriasis, run by BioMAS Ltd at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mild to Moderate Psoriasis
- What is being tested?
- AS101 Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient have a diagnosed mild to moderate stable plaque type psoriasis (less than 10% of body skin surface).
- Patient must be 18-70 years of age.
- General health must be adequate to allow for compliance with the requirements of this protocol.
- Patient or his/her legal guardian must sign an informed consent form prior to study participation.
- Patient must be able and willing to comply with all protocol requirements.
Who cannot join
- Patients who are mentally disabled or are otherwise unable to provide fully informed consent.
- Pregnant or breast-feeding females.
- Patients with evidence of an infection in the targeted zones.
- Patients with known sensitivity to any of the drug components.
- 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.
- Patient with psoriatic arthritis.
- Patients taking immunosuppressive drugs.
- Immunocompromised patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Topical Application of AS101 for the Treatment of Psoriasis
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.
- Conditions
- Mild to Moderate Psoriasis
- Being tested
- AS101 Cream
- Keywords
- AS101 Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS101 CreamDrug
4% AS101 Cream or Placebo cream, twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| AS101 Cream | Experimental | Twice daily topical application of AS101 cream on the psoriatic lesions for approx. 12 weeks is expected to clear the treated area. Receives: Drug: AS101 Cream |
| Placebo | Experimental | Twice daily topical application on the psoriatic lesions for 8 weeks will serve as control group. Receives: Drug: AS101 Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks treatment and 3 month follow up
Secondary outcomes (1)
The main secondary endpoints are to evaluate safety, tolerability of topical AS010 treatment and long term remission of psoriasis.
Measured: 12 weeks treatment and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Sponsor's considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMAS Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arie Ingbar, Prof, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788424
- Sponsor's protocol ID
- #72REV00
- Status last verified
- Jun 2008
- First submitted
- 10 Nov 2008
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Topical Application of AS101 for the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT00788424
- Acronym / sponsor ID
- #72REV00
- Conditions
- Mild to Moderate Psoriasis
- Keywords
- AS101 Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's considerations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioMAS LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AS101 Cream | Experimental | Drug: AS101 CreamTwice daily topical application of AS101 cream on the psoriatic lesions for approx. 12 weeks is expected to clear the treated area. |
| Placebo | Experimental | Drug: AS101 CreamTwice daily topical application on the psoriatic lesions for 8 weeks will serve as control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient have a diagnosed mild to moderate stable plaque type psoriasis (less than 10% of body skin surface).
- Patient must be 18-70 years of age.
- General health must be adequate to allow for compliance with the requirements of this protocol.
- Patient or his/her legal guardian must sign an informed consent form prior to study participation.
- Patient must be able and willing to comply with all protocol requirements.
Key exclusion criteria (8 listed)
- Patients who are mentally disabled or are otherwise unable to provide fully informed consent.
- Pregnant or breast-feeding females.
- Patients with evidence of an infection in the targeted zones.
- Patients with known sensitivity to any of the drug components.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AS101 Cream4% AS101 Cream or Placebo cream, twice a day for 12 weeks | Drug | AS101 Cream, Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arie Ingbar, Prof principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AS101 Cream in people with Mild to Moderate Psoriasis, run by BioMAS Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.