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Sponsor seeking additional financial support before starting the study
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | DPS-102 |
|
| 2 | Placebo Comparator | Vehicle |
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| 3 | Active Comparator | Calcipotriol Monotherapy |
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| 4 | Active Comparator | Nicotinamide Monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPS-102 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shay Marcus | Sponsor / DermiPsor Ltd. | Study Director |
| Nelli Konnikov, M.D. | Veterans Administration (VA) Hospital - Brockton, MA | Principal Investigator |
| Nancy Naguib, M.D. | Brockton VA Hospital | Principal Investigator |
| Carolyn Stanger | Boston VA Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston VA Hospital | Boston | Massachusetts | 02130 | United States | ||
| Brockton VA Hospital |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Vehicle / Placebo | Other | 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 Monotherapy | Drug | 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 Monotherapy | Drug | 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. |
|
| Brockton |
| Massachusetts |
| 02301 |
| United States |