PsoriasisPhase 4NCT01149252
Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis
A Phase 4 study testing Psoralait in people with Psoriasis, run by Trima, Israel Pharmaceutical Products at 1 site in Israel.
Trial summary
The purpose of this study is to determine the safety and efficacy of a new product, Psoralait, as compared to a placebo in the treatment of psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Psoralait
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Mar 2013
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been clinically diagnosed as suffering from psoriasis and are or aren't scheduled for Narrow Band Ultraviolet B (UVB)phototherapy of affected areas,excluding face and genitalia.
Who cannot join
- Women who are pregnant, lactating, planning to become pregnant, or women of child-bearing potential who have not successfully been using the same medically acceptable contraceptive methods over the previous 3 months, e.g., oral contraceptive agents, intrauterine device (IUD) and barrier method plus spermicide.
- Use of topical anti psoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within 2 weeks prior to the beginning of the study.
- Received systemic biologic therapy to treat psoriasis (for example: alefacept, etanercept, infliximab, adalimumab) within 12 weeks prior to the beginning of the study.
- Received systemic psoriasis therapy (for example: methotrexate, cyclosporine, systemic corticosteroids, retinoids such as acitretin) within 4 weeks prior to the beginning of the study.
- Received phototherapy (including laser), photo chemotherapy or climatotherapy within 4 weeks prior to the beginning of the study.
- Recent history (within past 12 months) of alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1.5 oz distilled spirits).
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- History of noncompliance to medical regimens or unwilling to comply with the study protocol.
- Participation in an investigational drug study within 30 days prior to the beginning of the study.
- Serious or unstable medical or psychological conditions that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Phototherapy and Dermatology Day Care Center, Sheba Medical Center, Tel Hashomer
Ramat Gan
About this study
Official title: Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis.
The purpose of this study is to determine the safety and efficacy of a new product, Psoralait, as compared to a placebo in the treatment of psoriasis.
- Conditions
- Psoriasis
- Being tested
- Psoralait, Placebo cream.
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsoralaitOther
Cream to be used as instructed.
Placebo cream.Other
Cream to be used as instructed
| Study group | Role | What they receive |
|---|---|---|
| Psoralait | Placebo comparator | Not described Receives: Other: Psoralait; Other: Placebo cream. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI).
Measured: After four weeks of treatment.
Secondary outcomes (1)
Dermatology Life Quality Index (DLQI).
Measured: After four weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Difficulties arouse in recruiting new patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trima, Israel Pharmaceutical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149252
- Sponsor's protocol ID
- Psoriasis
- Status last verified
- Dec 2014
- First submitted
- 20 Jun 2010
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis.
- ClinicalTrials.gov ID
- NCT01149252
- Acronym / sponsor ID
- Psoriasis
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties arouse in recruiting new patients
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Trima, Israel Pharmaceutical ProductsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Jun 2010 (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.
The purpose of this study is to determine the safety and efficacy of a new product, Psoralait, as compared to a placebo in the treatment of psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoralait | Placebo comparator | Other: Psoralait, Other: Placebo cream. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have been clinically diagnosed as suffering from psoriasis and are or aren't scheduled for Narrow Band Ultraviolet B (UVB)phototherapy of affected areas,excluding face and genitalia.
Key exclusion criteria (9 listed)
- Women who are pregnant, lactating, planning to become pregnant, or women of child-bearing potential who have not successfully been using the same medically acceptable contraceptive methods over the previous 3 months, e.g., oral contraceptive agents, intrauterine device (IUD) and barrier method plus spermicide.
- Use of topical anti psoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within 2 weeks prior to the beginning of the study.
- Received systemic biologic therapy to treat psoriasis (for example: alefacept, etanercept, infliximab, adalimumab) within 12 weeks prior to the beginning of the study.
- Received systemic psoriasis therapy (for example: methotrexate, cyclosporine, systemic corticosteroids, retinoids such as acitretin) within 4 weeks prior to the beginning of the study.
- Received phototherapy (including laser), photo chemotherapy or climatotherapy within 4 weeks prior to the beginning of the study.
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 |
|---|---|---|
| PsoralaitCream to be used as instructed. | Other | Psoralait |
| Placebo cream.Cream to be used as instructed | Other | Psoralait |
Primary outcome
Psoriasis Area and Severity Index (PASI).
Time frame: After four weeks of treatment.
1 secondary outcome
Dermatology Life Quality Index (DLQI).
Time frame: After four weeks of treatment.
Results and safety
The study was stopped early (reason given: Difficulties arouse in recruiting new patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psoralait in people with Psoriasis, run by Trima, Israel Pharmaceutical Products 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Dec 2014. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 stopped early (reason given: Difficulties arouse in recruiting new patients). Results are not available in the source record.
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?
Psoriasis Area and Severity Index (PASI). (time frame: After four weeks of treatment.). 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 17 Dec 2014.