Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-03 @ 11:14 AM
Study NCT ID:
NCT02993328
Status:
WITHDRAWN
Last Update Posted:
2019-01-17
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Plaque Psoriasis in Adults
Sponsor:
Santalis Pharmaceuticals, Inc.
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study location changed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: