This trial will be a double-blind, single-center, randomized, placebo controlled study to evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of mild-to-moderate plaque psoriasis.
Patients will enter the Screening Period once the informed consent and photographic consent process has been completed. Patients with mild-to-moderate plaque psoriasis, as defined by a Psoriasis Area and Severity Index (PASI) score between 2 and 12,36 appropriate for topical treatment that covers a minimum of 0.5% and a maximum of 10% BSA, in the permitted treatment areas, and who meet all of the inclusion and none of the exclusion criteria will be enrolled. Once subject eligibility is confirmed and the screening procedures completed, all enrolled subjects will start the Treatment Period of the study. All enrolled subjects will receive either 10% SAN021 or placebo serum (randomized in a 2:1 ratio) with the first dose applied at the Day 1 Study Visit. Subjects will be instructed on how to apply the study medication twice daily for 42 days. Subjects will return to the clinic for study-related assessments on Study Days 8, 15, 29 and a final visit on Day 43. On Study Day 50, subject will receive a Follow-up phone call and be queried for condition status since going off study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
Dermatology West
Fremantle, Western Australia, Australia
Safety measured by Adverse Events
Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
Time frame: Total from Baseline to Day 43
Number of patients reporting discomfort during or immediately following SAN021 application
Tolerability will be based on the number of patients reporting discomfort during or immediately following application of SAN021.
Time frame: Patient reported from Baseline to Day 43
Patients achieving a Physician's Global Assessment of "clear" or "almost clear" at any time-point from Baseline to day 43 of the study.
The primary preliminary efficacy endpoint will be number of patients achieving a Physician's Global Assessment of "clear" or "almost clear" at any time-point during the 43 days of therapy.
Time frame: Any time-point from Baseline to Day 43
Patients achieving at least a one grade improvement in Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.
Percentage of patients achieving at least a 1-grade improvement in Physicians Global Assessment score.
Time frame: Any time-point from Baseline to Day 43
Patients achieving a Psoriasis Area and Severity Index Score Improvement ≥ 25% at any time-point from Baseline to Day 43 of the study.
percentage of patients who have a ≥ 25% reduction in the Psoriasis Area and Severity Index (PASI) score at any time-point from Baseline to Day 43 of the study.
Time frame: Any time-point from Baseline to Day 43
Patients achieving a two grade improvement in Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.
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percentage of patients achieving a 2-grade improvement in the Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.
Time frame: Any time-point from Baseline to Day 43 of the study
Patients achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at any time-point from Baseline to Day 43 of the study.
percentage of patients who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any time-point from Baseline to Day 43 of the study.
Time frame: Any time-point from Baseline to Day 43 of the study.