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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
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.
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.
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.
Boston VA Hospital
Boston, Massachusetts, United States
Brockton VA Hospital
Brockton, Massachusetts, United States
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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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.