A Study of Improvement in Psoriasis Symptoms Associated with Combinations of Biologically Active Natural Substances (SFA-002) with Known Safety Profile
SFA Therapeutics
Summary
The purpose of this study is to determine the safety, metabolism and potential effect of drug product SFA-002 on mild moderate and severe chronic plaque psoriasis. Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms.
Description
Up to ninety volunteers with mild to moderate chronic plaque psoriasis will be recruited for an open label 24 week prospective study of the safety of 2 different dosages for 12 weeks of active therapy and 12 weeks of follow up. Blood will be drawn to determine any clinical effect on each group at the 12 week time mark and residual effects after 24 weeks. Throughout the study the investigators will perform both clinical and laboratory assessments to measure safety and response.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects of both sexes ≥18 years of age with at least one skin plaque that is \>5 cm2 due to known psoriasis considered clinically to be MILD to MODERATE or MODERATE to SEVERE during evaluation and diagnosis at least 1 year prior. Mild is defined as "Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling", whereas moderate is defined as "Clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling". * Have or have not been treated with phototherapy, systemic ther…
Interventions
- DrugSFA002
Study drug formula without excipient
- DrugSFA002
Study Drug SFA002 with excipient (Propionate)
Locations (3)
- NuLine Clinical Trial CenterPompano Beach, Florida
- Axis Clincals USA/ Red River Research Patners. LLCFargo, North Dakota
- Temple UniversityPhiladelphia, Pennsylvania