Trial Outcomes & Findings for A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts (NCT NCT01286441)
NCT ID: NCT01286441
Last Updated: 2019-05-29
Results Overview
During the Treatment Period, subjects will apply study medication to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks. Clinical evaluations, including wart counts, wart measurements and recording of adverse events and concomitant medications will be performed. Photographs of the treatment area will be taken at all study visits
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-05-29
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo for East Indian Sandalwood Oil ointment administered topically twice daily
Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
10% EISO
East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily
10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
20% EISO
East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily
20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
30% EISO
East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily
30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
46
|
48
|
|
Overall Study
COMPLETED
|
38
|
37
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
7
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts
Baseline characteristics by cohort
| Measure |
Placebo
n=45 Participants
Placebo for East Indian Sandalwood Oil ointment administered topically twice daily
Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
10% EISO
n=44 Participants
East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily
10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
20% EISO
n=46 Participants
East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily
20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
30% EISO
n=48 Participants
East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily
30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 17.5 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 17.9 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 15.2 • n=4 Participants
|
43.3 years
STANDARD_DEVIATION 16.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
167 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
44 participants
n=7 Participants
|
46 participants
n=5 Participants
|
48 participants
n=4 Participants
|
183 participants
n=21 Participants
|
|
Height
|
165.2 cm
STANDARD_DEVIATION 18.7 • n=5 Participants
|
167.8 cm
STANDARD_DEVIATION 9.9 • n=7 Participants
|
167.5 cm
STANDARD_DEVIATION 11.1 • n=5 Participants
|
168.1 cm
STANDARD_DEVIATION 10.5 • n=4 Participants
|
167.2 cm
STANDARD_DEVIATION 13.0 • n=21 Participants
|
|
Weight
|
81.8 kg
STANDARD_DEVIATION 21.3 • n=5 Participants
|
79.0 kg
STANDARD_DEVIATION 18.1 • n=7 Participants
|
75.9 kg
STANDARD_DEVIATION 17.4 • n=5 Participants
|
77.8 kg
STANDARD_DEVIATION 20.5 • n=4 Participants
|
78.6 kg
STANDARD_DEVIATION 19.4 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: FAS population was used for this outcome measure
During the Treatment Period, subjects will apply study medication to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks. Clinical evaluations, including wart counts, wart measurements and recording of adverse events and concomitant medications will be performed. Photographs of the treatment area will be taken at all study visits
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo for East Indian Sandalwood Oil ointment administered topically twice daily
Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
10% EISO
n=42 Participants
East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily
10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
20% EISO
n=45 Participants
East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily
20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
30% EISO
n=43 Participants
East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily
30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Complete Resolution of All Treated Warts by or at Week 12
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS population used for this outcome measure.
Partial Resolution is defined as \>/= 75% Reduction of treated wart
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo for East Indian Sandalwood Oil ointment administered topically twice daily
Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
10% EISO
n=42 Participants
East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily
10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
20% EISO
n=45 Participants
East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily
20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
30% EISO
n=43 Participants
East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily
30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Number of Subjects Achieving Partial Resolution of Treated Warts
|
2 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
10% EISO
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
20% EISO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30% EISO
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=45 participants at risk
Placebo for East Indian Sandalwood Oil ointment administered topically twice daily
Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
10% EISO
n=44 participants at risk
East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily
10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
20% EISO
n=46 participants at risk
East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily
20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
30% EISO
n=48 participants at risk
East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily
30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/45 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
2.3%
1/44 • Number of events 1 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
0.00%
0/46 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
0.00%
0/48 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
Other adverse events
| Measure |
Placebo
n=45 participants at risk
Placebo for East Indian Sandalwood Oil ointment administered topically twice daily
Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
10% EISO
n=44 participants at risk
East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily
10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
20% EISO
n=46 participants at risk
East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily
20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
30% EISO
n=48 participants at risk
East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily
30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
6.7%
3/45 • Number of events 3 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
0.00%
0/44 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
0.00%
0/46 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
0.00%
0/48 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
|
General disorders
Application Site reaction
|
0.00%
0/45 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
0.00%
0/44 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
0.00%
0/46 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
6.2%
3/48 • Number of events 3 • Over the entire duration of the treatment and follow up periods (24 WEEKS)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60