A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT02871479|
Recruitment Status : Completed
First Posted : August 18, 2016
Results First Posted : May 29, 2019
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis Eczema||Drug: SAN007 5% cream Drug: Placebo Drug: SAN007 10% cream||Phase 2|
Subjects will enter the Screening Period once the informed consent/ascent and photographic consent process has been completed. Subjects 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 subject eligibility is confirmed and the screening procedures completed, the subject will start the Treatment Period of the study. All enrolled subjects will receive either 5% SAN007 cream or placebo cream (randomized in a 2:1 ratio) OR 10% SAN007 cream or placebo cream (randomized in a 2:1 ratio) with the first dose applied at Visit 1 Baseline. Subjects will be instructed on how to apply the study medication twice daily for 28 days. Subjects will return to the clinic on Study Days 7,14 and 28 for study-related assessments. Subjects 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 subjects reporting discomfort during or immediately following application of SAN007. This will also be recorded as an AE. The study exclusion areas are not to be included 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, subjects will return to the study site according to the study schedule for interim assessments and recording of concomitant medication and adverse events (AEs).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled, Safety, Tolerability, and Efficacy Trial of a Novel Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For The Treatment of Atopic Dermatitis|
|Actual Study Start Date :||April 21, 2017|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
Experimental: SAN007 5% cream
A cream containing 5% East Indian sandalwood oil (EISO).
Drug: SAN007 5% cream
5% EISO in a cream formulation applied twice a day for up to 28 days.
Placebo Comparator: Placebo cream
The vehicle cream
A placebo cream containing the same components as the vehicle for the active intervention arm
Other Name: vehicle cream
Experimental: SAN007 10% cream
A cream containing 10% East Indian Sandalwood Oil (EISO).
Drug: SAN007 10% cream
10% EISO in a cream formulation applied twice a day for up to 28 days.
- Number of Patients With Adverse Events [ Time Frame: 28 days ]Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
- Percentage of Subjects Who Have a ≥ 50% Reduction in the Eczema Area and Severity Index (EASI) Score [ Time Frame: 28 days ]Percentage of subjects who have a ≥ 50% reduction in the Eczema Area and Severity Index (EASI) score at any point during the trial. Minimum value is a 0 and a maximum value is 72. Higher score denoting worse than a lower score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871479
|United States, Texas|
|Austin, Texas, United States, 78759|
|J&S Sudies Pharmaceutical|
|Bryan, Texas, United States, 77845|
|Progressive Clinical Research|
|San Antonio, Texas, United States, 78213|
|Texas Dermatology and Laser Specialists|
|San Antonio, Texas, United States, 78218|
|Clinical Trials of Texas|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||John Browning, MD||Texas Dermatology and Laser Specialists|