Plaque Psoriasis Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo Controlled Safety, Tolerability & Efficacy Trial Of A New Botanical Drug Product At One Dose Level For The Treatment Of Mild-To-Moderate Plaque Psoriasis In Adult Subjects
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.
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