Trial Outcomes & Findings for A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis (NCT NCT02871479)
NCT ID: NCT02871479
Last Updated: 2019-05-29
Results Overview
Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
28 days
Results posted on
2019-05-29
Participant Flow
Participant milestones
| Measure |
SAN007 5% Cream
A cream containing 5% East Indian sandalwood oil (EISO).
SAN007 5% cream: 5% EISO in a cream formulation applied twice a day for up to 28 days.
|
Placebo Cream
The vehicle cream
Placebo: A placebo cream containing the same components as the vehicle for the active intervention arm
|
SAN007 10% Cream
A cream containing 10% East Indian Sandalwood Oil (EISO).
SAN007 10% cream: 10% EISO in a cream formulation applied twice a day for up to 28 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
24
|
11
|
|
Overall Study
COMPLETED
|
33
|
21
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
SAN007 5% Cream
n=36 Participants
A cream containing 5% East Indian sandalwood oil (EISO).
SAN007 5% cream: 5% EISO in a cream formulation applied twice a day for up to 28 days.
|
Placebo Cream
n=24 Participants
The vehicle cream
Placebo: A placebo cream containing the same components as the vehicle for the active intervention arm
|
SAN007 10% Cream
n=11 Participants
A cream containing 10% East Indian Sandalwood Oil (EISO).
SAN007 10% cream: 10% EISO in a cream formulation applied twice a day for up to 28 days.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 15.59 • n=93 Participants
|
37.0 years
STANDARD_DEVIATION 13.36 • n=4 Participants
|
29.6 years
STANDARD_DEVIATION 10.4 • n=27 Participants
|
35.3 years
STANDARD_DEVIATION 14.21 • n=483 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
50 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
24 participants
n=4 Participants
|
11 participants
n=27 Participants
|
71 participants
n=483 Participants
|
|
Baseline EASI score
|
6.45 units on a scale
STANDARD_DEVIATION 3.51 • n=93 Participants
|
6.28 units on a scale
STANDARD_DEVIATION 4.128 • n=4 Participants
|
7.41 units on a scale
STANDARD_DEVIATION 5.73 • n=27 Participants
|
6.54 units on a scale
STANDARD_DEVIATION 4.074 • n=483 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The FAS group was used for this outcome measure
Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
Outcome measures
| Measure |
SAN007 5% Cream
n=35 Participants
A cream containing 5% East Indian sandalwood oil (EISO).
SAN007 5% cream: 5% EISO in a cream formulation applied twice a day for up to 28 days.
|
Placebo Cream
n=23 Participants
The vehicle cream
Placebo: A placebo cream containing the same components as the vehicle for the active intervention arm
|
SAN007 10% Cream
n=11 Participants
A cream containing 10% East Indian Sandalwood Oil (EISO).
SAN007 10% cream: 10% EISO in a cream formulation applied twice a day for up to 28 days.
|
|---|---|---|---|
|
Number of Patients With Adverse Events
|
7 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The FAS group was used for this outcome measure
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.
Outcome measures
| Measure |
SAN007 5% Cream
n=35 Participants
A cream containing 5% East Indian sandalwood oil (EISO).
SAN007 5% cream: 5% EISO in a cream formulation applied twice a day for up to 28 days.
|
Placebo Cream
n=23 Participants
The vehicle cream
Placebo: A placebo cream containing the same components as the vehicle for the active intervention arm
|
SAN007 10% Cream
n=11 Participants
A cream containing 10% East Indian Sandalwood Oil (EISO).
SAN007 10% cream: 10% EISO in a cream formulation applied twice a day for up to 28 days.
|
|---|---|---|---|
|
Percentage of Subjects Who Have a ≥ 50% Reduction in the Eczema Area and Severity Index (EASI) Score
|
17 Participants
|
12 Participants
|
6 Participants
|
Adverse Events
SAN007 5% Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Cream
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAN007 10% Cream
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAN007 5% Cream
n=36 participants at risk
A cream containing 5% East Indian sandalwood oil (EISO).
SAN007 5% cream: 5% EISO in a cream formulation applied twice a day for up to 28 days.
|
Placebo Cream
n=24 participants at risk
The vehicle cream
Placebo: A placebo cream containing the same components as the vehicle for the active intervention arm
|
SAN007 10% Cream
n=11 participants at risk
A cream containing 10% East Indian Sandalwood Oil (EISO).
SAN007 10% cream: 10% EISO in a cream formulation applied twice a day for up to 28 days.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/36 • AE's were observed over the course of the treatment period, which was 28 days.
|
0.00%
0/24 • AE's were observed over the course of the treatment period, which was 28 days.
|
9.1%
1/11 • AE's were observed over the course of the treatment period, which was 28 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/36 • AE's were observed over the course of the treatment period, which was 28 days.
|
8.3%
2/24 • AE's were observed over the course of the treatment period, which was 28 days.
|
0.00%
0/11 • AE's were observed over the course of the treatment period, which was 28 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60