NCT02871479

A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Santalis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 at least 18 years of age, with atopic dermatitis.

Detailed description

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).

Conditions

• Atopic Dermatitis
• Eczema

Interventions

Type	Name	Description
DRUG	SAN007 5% cream	5% EISO in a cream formulation applied twice a day for up to 28 days.
DRUG	Placebo	A placebo cream containing the same components as the vehicle for the active intervention arm
DRUG	SAN007 10% cream	10% EISO in a cream formulation applied twice a day for up to 28 days.

Timeline

• Start date: 2017-04-21
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2016-08-18
• Last updated: 2019-05-29
• Results posted: 2019-05-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study