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A Double-Blind, Multi-Center, Randomized, Placebo Controlled Safety, Tolerability & Efficacy Trial Of A New Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For The Treatment Of Mild-To-Moderate Plaque Psoriasis In Adults
This trial will be a double-blind, multi-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, appropriate for topical treatment that covers a minimum of 1.0% 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 7, 14, 28 and a final visit on Day 42. On Study Day 49, subject will receive a Follow-up phone call and be queried for condition status since going off study.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
DermResearch, Inc.
Austin, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Clinical Trial of Texas
San Antonio, Texas, United States
The Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Start Date
May 17, 2017
Primary Completion Date
December 13, 2017
Completion Date
December 14, 2017
Last Updated
May 29, 2019
69
ACTUAL participants
SAN021 Serum
DRUG
SAN021 Placebo
DRUG
Lead Sponsor
Santalis Pharmaceuticals, Inc.
Collaborators
NCT07116967
NCT07250802
NCT07449702
Data Source & Attribution
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