Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-28 @ 3:58 PM
Study NCT ID:
NCT03000595
Status:
WITHDRAWN
Last Update Posted:
2019-01-17
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of a Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis
Sponsor:
Santalis Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Placebo-Controlled, Safety, Tolerability, and Efficacy Trial of a Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For The Treatment of Atopic Dermatitis
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WITHDRAWN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, randomized, placebo-controlled, safety, tolerability and efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment regimen when administered daily for up to 28 days to patients from 3 months to 65 years of age, with atopic dermatitis.
Detailed Description:
Patients will enter the Screening Period once the informed consent/ascent and photographic consent process has been completed. Patients with a total body surface area (BSA) of ≥2% and ≤ 15% atopic dermatitis involvement, in the treatable areas, and who meet all of the inclusion and none of the exclusion criteria will be enrolled.
Once patient eligibility is confirmed and the screening procedures completed, the patient will start the Treatment Period of the study. All enrolled patients will receive either 5% SAN007 cream or placebo cream (randomized in a 2:1 ratio) with the first dose applied at the Day 1 Study Visit. Patients and/or their legally authorized representative will be instructed on how to apply the study medication twice daily for 28 days. Patients will return to the clinic on Study Days 7,14 and 28 for study-related assessments. Patients and/or their LAR will receive a telephone contact from the site, on Study Days 21 and 35.
Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
In addition cutaneous tolerability will be evaluated at each visit. Tolerability evaluation will be based on patients reporting discomfort during or immediately following application of SAN007. This will also be recorded as an AE. The study exclusion areas are to be not to be used in this evaluation.
Efficacy will be assessed at each study visit through the completion of the IGA, EASI and BSA calculation.
During the active treatment period, Patients will return to the study site according to the study schedule for interim assessments and recording of concomitant medication and adverse events (AEs).
Once patient eligibility is confirmed and the screening procedures completed, the patient will start the Treatment Period of the study. All enrolled patients will receive either 5% SAN007 cream or placebo cream (randomized in a 2:1 ratio) with the first dose applied at the Day 1 Study Visit. Patients and/or their legally authorized representative will be instructed on how to apply the study medication twice daily for 28 days. Patients will return to the clinic on Study Days 7,14 and 28 for study-related assessments. Patients and/or their LAR will receive a telephone contact from the site, on Study Days 21 and 35.
Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
In addition cutaneous tolerability will be evaluated at each visit. Tolerability evaluation will be based on patients reporting discomfort during or immediately following application of SAN007. This will also be recorded as an AE. The study exclusion areas are to be not to be used in this evaluation.
Efficacy will be assessed at each study visit through the completion of the IGA, EASI and BSA calculation.
During the active treatment period, Patients will return to the study site according to the study schedule for interim assessments and recording of concomitant medication and adverse events (AEs).
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?: