A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis
NCT02871479 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71
Last updated 2019-05-29
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.
Conditions
Interventions
- DRUG
-
SAN007 5% cream
5% EISO in a cream formulation applied twice a day for up to 28 days.
- DRUG
-
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.
Sponsors & Collaborators
-
ClinDatrix, Inc.
collaborator INDUSTRY -
Texas Dermatology and Laser Specialists
collaborator UNKNOWN -
Clinical Trials of Texas, Inc.
collaborator OTHER -
Derm Research, PLLC
collaborator OTHER -
Progressive Clinical Research
collaborator OTHER -
U.S. Dermatology Partners Bryan
collaborator UNKNOWN -
Santalis Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
John Browning, MD · Texas Dermatology and Laser Specialists
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-21
- Primary Completion
- 2018-08-31
- Completion
- 2018-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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