PsoriasisPhase 2NCT01368887
Study to Test the Effectiveness of a New Treatment for Scalp Psoriasis
A Phase 2 study testing DPS-102, Calcipotriol Monotherapy and Nicotinamide Monotherapy in people with Psoriasis, run by DermiPsor, Ltd. at 2 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of DermiPsor's DPS-102 (test product) in patients with scalp Psoroasis. The study is also intended to assess the safety of the product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- DPS-102, Calcipotriol Monotherapy and Nicotinamide Monotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of age 18 or older
- Patient with a personal history of scalp psoriasis
- Patient with treatable lesions
- Patient with a TSS score equal or lower than 9.
- Patient with a PGA score equal or lower than 5.
- Patient with a negative urine pregnancy test at inclusion for women of childbearing potential and using an efficient contraceptive (oral contraceptives, IUD, or tubal ligation)
- Patient agreeing to participate to the study and to sign a written informed consent and comply with study requirements.
Who cannot join
- Patient treated with topical scalp treatment for scalp psoriasis within two weeks prior to the inclusion in the study (corticoids, retinoids, vitamin D derivatives),
- Patient treated with systemic treatment for psoriasis (biologics, methotrexate, cyclosporine, retinoids) within one month prior to the inclusion in the study
- Patient taking systemic niacin or multivitamins within past two weeks
- Patient who start or modify a treatment with beta-blockers within one month prior to the inclusion in the study
- Patient with PEG (Poly Ethylene Glycol) allergy
- Pregnant or breast feeding female or female who do not use contraception,
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- Patient with an history of hypersensitivity to Dovonex/Daivonex
- Patient who has participated in a clinical trial within three month prior inclusion,
- Patients on Carbamazepine and Primidione (the clearance of Primidione and Carbamazepine may be reduced with the concomitant use of Nicotinamide)
- Patient who is under guardianship, or unable to understand the information (for linguistic or mental reason), or unwilling to give her/his informed consent to participate in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston VA Hospital
Boston, Massachusetts, 02130
Brockton VA Hospital
Brockton, Massachusetts, 02301
About this study
Official title: Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis
The purpose of this study is to test the effectiveness of DermiPsor's DPS-102 (test product) in patients with scalp Psoroasis. The study is also intended to assess the safety of the product.
Read the detailed description
Psoriasis is a non-contagious skin disorder affecting up to 2% of the world population. It is estimated that 26 million people in the U.S. and Europe suffer from psoriasis. Forty percent (40%) of these suffer from psoriasis of the scalp. Currently, there are three primary modalities for the treatment of psoriasis: topical, phototherapy and systemic treatments. While existing treatments provide varying degrees of relief for this illness, they do not provide a long-term cure. Additionally, there is evidence that some of these existing treatments may cause significant side effect. The purpose of this study is to demonstrate that DermiPsor's DPS-102 (test product) is statistically more effective for the treatment of psoriasis current topical treatment options. It is also intended to assess the safety of DPS-102.
- Conditions
- Psoriasis
- Being tested
- DPS-102, Vehicle / Placebo, Calcipotriol Monotherapy, Nicotinamide Monotherapy
- Keywords
- psoriasis, scalp psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPS-102Drug
The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
Vehicle / PlaceboOther
The patient will apply the vehicle twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
Calcipotriol MonotherapyDrug
The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
Nicotinamide MonotherapyDrug
The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DPS-102 Receives: Drug: DPS-102 |
| 2 | Placebo comparator | Vehicle Receives: Other: Vehicle / Placebo |
| 3 | Active comparator | Calcipotriol Monotherapy Receives: Drug: Calcipotriol Monotherapy |
| 4 | Active comparator | Nicotinamide Monotherapy Receives: Drug: Nicotinamide Monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Physician's Global Assessment ("PGA") criteria. The PGA involves a 7 point scale (clear, minimal, mild, moderate, severe and very severe) and grading conducted at 0, 2, 4, 8 and 12 weeks.
The number of participants at each PGA scale level assessed at 0,2,4,8,and 12 weeks and a comparison of each individual's scale assessments over the 12 week period to assess any changes.
Measured: 12 weeks
Secondary outcomes (1)
Review of haematology and blood chemistry test results, and any adverse event reports received.
Number of participants who experience adverse events and type of adverse event in each case.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startApr 2013
- Primary completionNov 2013 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: Sponsor seeking additional financial support before starting the study
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermiPsor, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shay Marcus, Study director, Sponsor / DermiPsor Ltd.Nelli Konnikov, M.D., Principal investigator, Veterans Administration (VA) Hospital - Brockton, MANancy Naguib, M.D., Principal investigator, Brockton VA HospitalCarolyn Stanger, Principal investigator, Boston VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368887
- Sponsor's protocol ID
- DermiPsor 2008-103
- Status last verified
- Jun 2011
- First submitted
- 6 Jun 2011
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT01368887
- Acronym / sponsor ID
- DermiPsor 2008-103
- Conditions
- Psoriasis
- Keywords
- psoriasis, scalp psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor seeking additional financial support before starting the study
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- DermiPsor, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 8 Jun 2011 (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 test the effectiveness of DermiPsor's DPS-102 (test product) in patients with scalp Psoroasis. The study is also intended to assess the safety of the product.
Detailed description
Psoriasis is a non-contagious skin disorder affecting up to 2% of the world population. It is estimated that 26 million people in the U.S. and Europe suffer from psoriasis. Forty percent (40%) of these suffer from psoriasis of the scalp. Currently, there are three primary modalities for the treatment of psoriasis: topical, phototherapy and systemic treatments. While existing treatments provide varying degrees of relief for this illness, they do not provide a long-term cure. Additionally, there is evidence that some of these existing treatments may cause significant side effect. The purpose of this study is to demonstrate that DermiPsor's DPS-102 (test product) is statistically more effective for the treatment of psoriasis current topical treatment options. It is also intended to assess the safety of DPS-102.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DPS-102DPS-102 |
| 2 | Placebo comparator | Other: Vehicle / PlaceboVehicle |
| 3 | Active comparator | Drug: Calcipotriol MonotherapyCalcipotriol Monotherapy |
| 4 | Active comparator | Drug: Nicotinamide MonotherapyNicotinamide Monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female of age 18 or older
- Patient with a personal history of scalp psoriasis
- Patient with treatable lesions
- Patient with a TSS score equal or lower than 9.
- Patient with a PGA score equal or lower than 5.
Key exclusion criteria (10 listed)
- Patient treated with topical scalp treatment for scalp psoriasis within two weeks prior to the inclusion in the study (corticoids, retinoids, vitamin D derivatives),
- Patient treated with systemic treatment for psoriasis (biologics, methotrexate, cyclosporine, retinoids) within one month prior to the inclusion in the study
- Patient taking systemic niacin or multivitamins within past two weeks
- Patient who start or modify a treatment with beta-blockers within one month prior to the inclusion in the study
- Patient with PEG (Poly Ethylene Glycol) allergy
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 |
|---|---|---|
| DPS-102The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1. | Drug | 1 |
| Vehicle / PlaceboThe patient will apply the vehicle twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1. | Other | 2 |
| Calcipotriol MonotherapyThe patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1. | Drug | 3 |
| Nicotinamide MonotherapyThe patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1. | Drug | 4 |
Primary outcome
The Physician's Global Assessment ("PGA") criteria. The PGA involves a 7 point scale (clear, minimal, mild, moderate, severe and very severe) and grading conducted at 0, 2, 4, 8 and 12 weeks.
Time frame: 12 weeks
The number of participants at each PGA scale level assessed at 0,2,4,8,and 12 weeks and a comparison of each individual's scale assessments over the 12 week period to assess any changes.
1 secondary outcome
Review of haematology and blood chemistry test results, and any adverse event reports received.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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.
Shay Marcus study director
Sponsor / DermiPsor Ltd.
Nelli Konnikov, M.D. principal investigator
Veterans Administration (VA) Hospital - Brockton, MA
Nancy Naguib, M.D. principal investigator
Brockton VA Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DPS-102, Calcipotriol Monotherapy and Nicotinamide Monotherapy in people with Psoriasis, run by DermiPsor, Ltd. at 2 sites in United States.
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 7 inclusion and 10 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: paused, as of the sponsor's last update on 8 Jun 2011. 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 United States. 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 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?
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?
The Physician's Global Assessment ("PGA") criteria. The PGA involves a 7 point scale (clear, minimal, mild, moderate, severe and very severe) and grading conducted at 0, 2, 4, 8 and 12 weeks. (time frame: 12 weeks). 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 8 Jun 2011.