Efficacy and Safety of Prurisol Administered Orally for Active Mild to Moderate Chronic Plaque Psoriasis
Plaque Psoriasis
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Psoriasis, Topical Psoriasis, Mild Psoriasis, Moderate Psoriasis, Active Psoriasis, Plaque Psoriasis, Skin Diseases
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant female adults aged 18 years with a clinical diagnosis of stable (at least 6 months) plaque psoriasis, not including scalp or intertriginous areas.
The extent of psoriasis must meet all of the following three (3) criteria:
- Total Body Surface Area (BSA) affected by plaque psoriasis of 10% to 20% inclusive
- Investigator's Global Assessment (IGA) score of the severity of psoriasis of 2 or 3 (5- point ordinal scale)
- Identification of a target psoriatic lesion with a score of 3 on the Target Lesion Assessment scale (5-point ordinal scale) for Scaling. (Other psoriatic lesions may have lower scaling scores.)
- Females of reproductive potential must not be pregnant
- Female subjects with reproductive potential, if sexually active, must agree to use reliable means of contraception
- The subject must agree to avoid prolonged exposure to the sun and avoid the use of tanning booths or other ultraviolet light sources during the study.
- The subject must provide signed and dated written informed consent to participate in the clinical study.
Exclusion Criteria:
- 1. Females of reproductive potential who are not using reliable contraception.
- Presence of any non-psoriatic uncontrolled (in the Investigator's medical opinion) systemic disease. i
- Unstable forms of psoriasis, e.g. guttate, erythrodermic, exfoliative, palmoplantar, nail, or pustular.
- Use within 6 months of biologic treatment for psoriasis
- Use within 24 months of chemotherapy or radiation therapy.
- Use within 2 months of any systemic immunosuppressive therapy.
- Use within 1 month of (1) systemic corticosteroids, (2) systemic antibiotics, (3) systemic antipsoriasis treatments (e.g. methotrexate, corticosporin, hydroxyurea), (4) PUVA therapy, (5) UVB, (6) systemic anti-inflammatory treatment.
- Use within 2 weeks of topical antipsoriasis drugs or topical corticosteroids or topical retinoids.
- Presence of a condition (e.g., history of frequent consumption of substantial quantities of alcohol, or an untreated psychiatric condition) that makes it unlikely that the requirements of the protocol will be completed.
- History of any previous use of a Tumor Necrosis Factor (TNF) blocker or other immunomodulating drug as therapy for psoriasis within the 6 months prior to screening.
- History of any allergic reaction to any formulation of abacavir.
- Previous treatment with any abacavir-containing product, e.g., Ziagen®, Epzicom®, or Trizivir®.
Sites / Locations
- Cellceutix Study Center
- Cellceutix Study Center
- Cellceutix Study Center
- Cellceutix Study Center
- Cellceutix Study Center
- Cellceutix Study Center
- Cellceutix Study Center
- Cellceutix Study Center
- Cellceutix Study Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
50mg of Purisol daily
100mg of Purisol daily
200mg of Purisol daily
Placebo daily
One (1) 50 mg tablet of Prurisol and one (1) matching placebo tablet given AM and two (2) matching placebo tablets given PM for 84 (± 3) days
One (1) 50 mg tablets of Prurisol and one (1) matching placebo tablet given twice daily (AM and PM) for 84 (± 3) days
Two (2) 50 mg tablets of Prurisol given twice daily (AM and PM) for 84 (± 3) days
Two (2) placebo tablets given twice daily (AM and PM) for 84 (± 3) days