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A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01286441
Recruitment Status : Completed
First Posted : January 31, 2011
Results First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
ViroXis Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Common Warts
Interventions Drug: 10% EISO
Drug: Placebo
Drug: 20% EISO
Drug: 30% EISO
Enrollment 183
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 10% EISO 20% EISO 30% EISO
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 45 44 46 48
Completed 38 37 39 37
Not Completed 7 7 7 11
Arm/Group Title Placebo 10% EISO 20% EISO 30% EISO Total
Hide Arm/Group Description

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 45 44 46 48 183
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 44 participants 46 participants 48 participants 183 participants
46.6  (15.4) 43.2  (17.5) 44.3  (17.9) 39.5  (15.2) 43.3  (16.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 46 participants 48 participants 183 participants
Female
26
  57.8%
24
  54.5%
27
  58.7%
28
  58.3%
105
  57.4%
Male
19
  42.2%
20
  45.5%
19
  41.3%
20
  41.7%
78
  42.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 46 participants 48 participants 183 participants
Hispanic or Latino
13
  28.9%
15
  34.1%
14
  30.4%
13
  27.1%
55
  30.1%
Not Hispanic or Latino
32
  71.1%
29
  65.9%
32
  69.6%
35
  72.9%
128
  69.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 46 participants 48 participants 183 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.2%
0
   0.0%
1
   2.2%
1
   2.1%
3
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
1
   0.5%
Black or African American
0
   0.0%
3
   6.8%
1
   2.2%
3
   6.3%
7
   3.8%
White
44
  97.8%
39
  88.6%
43
  93.5%
41
  85.4%
167
  91.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   4.5%
0
   0.0%
3
   6.3%
5
   2.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 44 participants 46 participants 48 participants 183 participants
45 44 46 48 183
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 45 participants 44 participants 46 participants 48 participants 183 participants
165.2  (18.7) 167.8  (9.9) 167.5  (11.1) 168.1  (10.5) 167.2  (13.0)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 45 participants 44 participants 46 participants 48 participants 183 participants
81.8  (21.3) 79.0  (18.1) 75.9  (17.4) 77.8  (20.5) 78.6  (19.4)
1.Primary Outcome
Title Complete Resolution of All Treated Warts by or at Week 12
Hide Description 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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for this outcome measure
Arm/Group Title Placebo 10% EISO 20% EISO 30% EISO
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 43 42 45 43
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.7%
5
  11.9%
2
   4.4%
3
   7.0%
2.Secondary Outcome
Title Number of Subjects Achieving Partial Resolution of Treated Warts
Hide Description Partial Resolution is defined as >/= 75% Reduction of treated wart
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population used for this outcome measure.
Arm/Group Title Placebo 10% EISO 20% EISO 30% EISO
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 43 42 45 43
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.7%
4
   9.5%
5
  11.1%
8
  18.6%
Time Frame Over the entire duration of the treatment and follow up periods (24 WEEKS)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 10% EISO 20% EISO 30% EISO
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Placebo 10% EISO 20% EISO 30% EISO
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo 10% EISO 20% EISO 30% EISO
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      1/44 (2.27%)      0/46 (0.00%)      0/48 (0.00%)    
Infections and infestations         
Bronchitis *  0/45 (0.00%)  0 1/44 (2.27%)  1 0/46 (0.00%)  0 0/48 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 10% EISO 20% EISO 30% EISO
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/45 (6.67%)      0/44 (0.00%)      0/46 (0.00%)      3/48 (6.25%)    
General disorders         
Application Site reaction *  0/45 (0.00%)  0 0/44 (0.00%)  0 0/46 (0.00%)  0 3/48 (6.25%)  3
Infections and infestations         
Sinusitis *  3/45 (6.67%)  3 0/44 (0.00%)  0 0/46 (0.00%)  0 0/48 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Paul Castella Ph.D.
Organization: Santalis Pharmaceuticals
Phone: 210-399-2316 ext 101
EMail: paulc@santalispharma.com
Layout table for additonal information
Responsible Party: ViroXis Corporation
ClinicalTrials.gov Identifier: NCT01286441    
Other Study ID Numbers: VIR001-01
First Submitted: January 27, 2011
First Posted: January 31, 2011
Results First Submitted: April 10, 2019
Results First Posted: May 29, 2019
Last Update Posted: May 29, 2019