Psoriasis VulgarisPhase 1NCT01743118
Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris
A Phase 1 study testing SPS4251 Ointment and Daivonex® ointment in people with Psoriasis Vulgaris, run by Circassia Limited at 2 sites in Germany.
Trial summary
The current most important topical treatments for psoriasis are vitamin D3 analogues and/or corticosteroids. The possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- SPS4251 Ointment and Daivonex® ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2013to Jul 2013
- Phase
- Phase 1
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men aged 18 years or older
- subjects with mild to moderate psoriasis vulgaris in a chronic stable phase
- subject with up to three stable plaques with an area sufficient for five treatment fields
- Plaques to be treated should have a comparable thickness of the Echo Lucent Band of at least 200 µm
Who cannot join
- Subjects with guttate psoriasis, punctate psoriasis, erythrodermic psoriasis, psoriatic arthropathy and pustular psoriasis
- Local treatment with antipsoriatics in the 4 weeks preceding and/or during the trial, and any topical antipsoriatic treatment on the plaques to be treated in this trial in the 8 weeks before first treatment and/or during the trial
- Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial;
- Treatment with systemic medications or medications acting locally which might have countered or influenced the trial aim
- Contraindications according to summary of product characteristics of Daivonex® Ointment;
- UV-therapy within four weeks before first treatment and during the trial
Show all 11Show fewer
- Symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before baseline visit and during the trial
- Any history of cardiovascular disease
- Any evidence of ECG abnormality on screening ECG
- Close affiliation with the Investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of the Sponsor;
- Subject is institutionalized because of legal or regulatory order.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase Ib, Two-centre, Randomised, Observer-blind, Placebo- and Comparator Controlled Trial to Evaluate the Safety, Tolerability and Antipsoriatic Efficacy of Three Strengths of a Topical SPS4251 Formulation in a Psoriasis Plaque Test
The current most important topical treatments for psoriasis are vitamin D3 analogues and/or corticosteroids. The possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel.
The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical Vitamin-D analogue ointment in a psoriasis plaque test.
- Conditions
- Psoriasis Vulgaris
- Being tested
- SPS4251 Ointment, Placebo, Daivonex® ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPS4251 OintmentDrug
Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)
PlaceboDrug
Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)
Daivonex® ointmentDrug
Also called calcipotriol
Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments).
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis Plaque Test | Experimental | SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment Receives: Drug: SPS4251 Ointment; Drug: Placebo; Drug: Daivonex® ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate
Measured: Up to Day 12
Secondary outcomes (2)
Evaluation of anti-psoriatic efficacy by clinical assessment
Measured: Up to day 12
Number of subjects with Adverse Events
Measured: Up to day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743118
- Sponsor's protocol ID
- SP001
- Status last verified
- Jul 2013
- First submitted
- 3 Dec 2012
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib, Two-centre, Randomised, Observer-blind, Placebo- and Comparator Controlled Trial to Evaluate the Safety, Tolerability and Antipsoriatic Efficacy of Three Strengths of a Topical SPS4251 Formulation in a Psoriasis Plaque Test
- ClinicalTrials.gov ID
- NCT01743118
- Acronym / sponsor ID
- SP001
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Dec 2012 (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 current most important topical treatments for psoriasis are vitamin D3 analogues and/or corticosteroids. The possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel.
The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical Vitamin-D analogue ointment in a psoriasis plaque test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis Plaque Test | Experimental | Drug: SPS4251 Ointment, Drug: Placebo, Drug: Daivonex® ointmentSPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men aged 18 years or older
- subjects with mild to moderate psoriasis vulgaris in a chronic stable phase
- subject with up to three stable plaques with an area sufficient for five treatment fields
- Plaques to be treated should have a comparable thickness of the Echo Lucent Band of at least 200 µm
Key exclusion criteria (11 listed)
- Subjects with guttate psoriasis, punctate psoriasis, erythrodermic psoriasis, psoriatic arthropathy and pustular psoriasis
- Local treatment with antipsoriatics in the 4 weeks preceding and/or during the trial, and any topical antipsoriatic treatment on the plaques to be treated in this trial in the 8 weeks before first treatment and/or during the trial
- Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial;
- Treatment with systemic medications or medications acting locally which might have countered or influenced the trial aim
- Contraindications according to summary of product characteristics of Daivonex® Ointment;
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 |
|---|---|---|
| SPS4251 OintmentApproximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments) | Drug | Psoriasis Plaque Test |
| PlaceboApproximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments) | Drug | Psoriasis Plaque Test |
| Daivonex® ointmentAlso: calcipotriolApproximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments). | Drug | Psoriasis Plaque Test |
Primary outcome
Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate
Time frame: Up to Day 12
2 secondary outcomes
Evaluation of anti-psoriatic efficacy by clinical assessment
Time frame: Up to day 12
Number of subjects with Adverse Events
Time frame: Up to day 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPS4251 Ointment and Daivonex® ointment in people with Psoriasis Vulgaris, run by Circassia Limited at 2 sites in Germany.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate (time frame: Up to Day 12). 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 Jul 2013.