Trial Outcomes & Findings for Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris) (NCT NCT02393417)
NCT ID: NCT02393417
Last Updated: 2019-06-04
Results Overview
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
243 participants
Primary outcome timeframe
45 weeks
Results posted on
2019-06-04
Participant Flow
Screen Fail Rate of 30% - 12% due to warts not meeting criteria, 12% due to DTH measurement not meeting criteria, 5% other reasons.
Participant milestones
| Measure |
Pooled Placebo
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
45
|
40
|
41
|
|
Overall Study
Completed Treatment
|
30
|
34
|
32
|
30
|
|
Overall Study
COMPLETED
|
28
|
32
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
10
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=44 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=39 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=40 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.7 years
n=5 Participants
|
35.6 years
n=7 Participants
|
33.5 years
n=5 Participants
|
30.2 years
n=4 Participants
|
33.6 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
147 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
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
39 participants
n=5 Participants
|
40 participants
n=4 Participants
|
166 participants
n=21 Participants
|
|
Response (size of induration) to CANDIN injection during screening
|
9.95 mm
STANDARD_DEVIATION 4.116 • n=5 Participants
|
12.09 mm
STANDARD_DEVIATION 5.672 • n=7 Participants
|
11.01 mm
STANDARD_DEVIATION 4.534 • n=5 Participants
|
10.30 mm
STANDARD_DEVIATION 3.902 • n=4 Participants
|
10.85 mm
STANDARD_DEVIATION 4.661 • n=21 Participants
|
|
Body Weight
|
93.91 kg
STANDARD_DEVIATION 28.165 • n=5 Participants
|
90.30 kg
STANDARD_DEVIATION 22.753 • n=7 Participants
|
81.77 kg
STANDARD_DEVIATION 18.977 • n=5 Participants
|
83.27 kg
STANDARD_DEVIATION 21.929 • n=4 Participants
|
87.54 kg
STANDARD_DEVIATION 23.629 • n=21 Participants
|
|
Body Mass Index
|
30.75 kg/m2
STANDARD_DEVIATION 8.812 • n=5 Participants
|
29.11 kg/m2
STANDARD_DEVIATION 6.291 • n=7 Participants
|
27.85 kg/m2
STANDARD_DEVIATION 6.461 • n=5 Participants
|
27.42 kg/m2
STANDARD_DEVIATION 7.486 • n=4 Participants
|
28.83 kg/m2
STANDARD_DEVIATION 7.392 • n=21 Participants
|
|
Location of Common Warts
Left Hand
|
29 each
n=5 Participants
|
21 each
n=7 Participants
|
25 each
n=5 Participants
|
35 each
n=4 Participants
|
110 each
n=21 Participants
|
|
Location of Common Warts
Right Hand
|
36 each
n=5 Participants
|
36 each
n=7 Participants
|
26 each
n=5 Participants
|
37 each
n=4 Participants
|
135 each
n=21 Participants
|
|
Location of Common Warts
Left Arm
|
6 each
n=5 Participants
|
4 each
n=7 Participants
|
1 each
n=5 Participants
|
5 each
n=4 Participants
|
16 each
n=21 Participants
|
|
Location of Common Warts
Right Arm
|
0 each
n=5 Participants
|
7 each
n=7 Participants
|
3 each
n=5 Participants
|
2 each
n=4 Participants
|
12 each
n=21 Participants
|
|
Location of Common Warts
Left Leg
|
3 each
n=5 Participants
|
1 each
n=7 Participants
|
3 each
n=5 Participants
|
5 each
n=4 Participants
|
12 each
n=21 Participants
|
|
Location of Common Warts
Right Leg
|
4 each
n=5 Participants
|
1 each
n=7 Participants
|
3 each
n=5 Participants
|
1 each
n=4 Participants
|
9 each
n=21 Participants
|
|
Location of Common Warts
Left Foot (excluding sole)
|
1 each
n=5 Participants
|
0 each
n=7 Participants
|
3 each
n=5 Participants
|
2 each
n=4 Participants
|
6 each
n=21 Participants
|
|
Location of Common Warts
Right Foot (excluding sole)
|
3 each
n=5 Participants
|
0 each
n=7 Participants
|
1 each
n=5 Participants
|
2 each
n=4 Participants
|
6 each
n=21 Participants
|
|
Area of Primary Injected Wart
|
32.19 mm^2
n=5 Participants
|
41.47 mm^2
n=7 Participants
|
36.95 mm^2
n=5 Participants
|
27.66 mm^2
n=4 Participants
|
34.68 mm^2
n=21 Participants
|
|
Age of Primary Injected Wart(s)
|
228.9 weeks
n=5 Participants
|
202.0 weeks
n=7 Participants
|
174.7 weeks
n=5 Participants
|
196.8 weeks
n=4 Participants
|
201.3 weeks
n=21 Participants
|
PRIMARY outcome
Timeframe: 45 weeksPopulation: Modified Intent to Treat (mITT) - subjects that received at least one post baseline measurement of the primary wart(s)
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Outcome measures
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=44 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=39 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=40 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit
|
16 Participants
|
29 Participants
|
31 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 45 weeksPopulation: mITT - Subjects that received at least one post baseline measurement of the primary wart(s)
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Outcome measures
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=44 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=39 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=40 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit
|
7 Participants
|
12 Participants
|
20 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 4 month follow up visit at 45 weeksPopulation: mITT - Subjects that received at least one post baseline measurement of the primary wart(s)
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Outcome measures
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=44 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=39 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=40 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit
|
16 Participants
|
20 Participants
|
27 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 45 weeksPopulation: mITT. Subjects that received at least one post baseline measurement of the primary wart(s). Cohort 3 values represent resolution of largest primary wart
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Outcome measures
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=44 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=39 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=40 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)
|
10 injection visits
Interval 10.0 to 10.0
|
5 injection visits
Interval 3.0 to 10.0
|
5 injection visits
Interval 3.0 to 10.0
|
4 injection visits
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: 45 weeksPopulation: mITT - Subjects that received at least one post baseline measurement of the primary wart(s)
Outcome measures
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=44 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=39 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=40 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)
|
9.0 injection visits
Interval 6.0 to 10.0
|
3.0 injection visits
Interval 2.0 to 4.0
|
2.0 injection visits
Interval 2.0 to 4.0
|
2.0 injection visits
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 45 weeksPopulation: mITT - Subjects that received at least on post baseline measurement of the primary wart(s)
Outcome measures
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=44 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=39 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=40 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts
|
10.0 injection visits
Interval 8.0 to
Value cannot be estimated due to insufficient number of participants with events
|
5.0 injection visits
Interval 4.0 to 9.0
|
4.0 injection visits
Interval 2.0 to 6.0
|
3.0 injection visits
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 45 weeksPopulation: mITT - Subjects that received at least one post baseline measurement of the primary wart(s)
Scarring at any visit, many reports were transient being noted at only one or two visits and noted as resolving during the course of the study
Outcome measures
| Measure |
Pooled Placebo
n=18 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=28 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=31 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=33 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s)
|
1 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 45 weeksPopulation: Only mITT subjects with complete resolution of warts included in this endpoint
Outcome measures
| Measure |
Pooled Placebo
n=18 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=28 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=31 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=33 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s)
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 45 weeksPopulation: Safety Population- All randomized subjects who received at least one intralesional dose of study medication. Subjects experiencing multiple types of reactions were counted once for each type, but only once across all reactions.
Outcome measures
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=45 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=40 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=41 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Tenderness
|
27 participants
|
42 participants
|
40 participants
|
39 participants
|
|
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Pain
|
15 participants
|
41 participants
|
35 participants
|
39 participants
|
|
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Pruritis/Itching
|
13 participants
|
36 participants
|
32 participants
|
33 participants
|
|
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Edema/Swelling
|
9 participants
|
17 participants
|
27 participants
|
23 participants
|
|
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Erythema/Redness
|
3 participants
|
18 participants
|
25 participants
|
23 participants
|
|
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Peeling
|
1 participants
|
3 participants
|
2 participants
|
8 participants
|
|
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Scarring
|
1 participants
|
6 participants
|
2 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 45 weeksPopulation: mITT- Subjects that received at least one post baseline measurement of the primary wart(s)
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Outcome measures
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=44 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=39 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=40 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart
|
18 number of warts resolved
|
29 number of warts resolved
|
31 number of warts resolved
|
29 number of warts resolved
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 45 weeksPopulation: mITT - subjects that received at least one post baseline measurement of the primary wart(s)
Outcome measures
| Measure |
Pooled Placebo
n=20 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=33 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=34 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=34 Participants
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit.
|
5 wart recurrences
|
14 wart recurrences
|
13 wart recurrences
|
24 wart recurrences
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 45 weeksPopulation: mITT- Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Outcome measures
| Measure |
Pooled Placebo
n=43 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=84 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=39 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History
Naive
|
12 Participants
|
24 Participants
|
11 Participants
|
—
|
|
Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History
Cryotherapy
|
6 Participants
|
27 Participants
|
17 Participants
|
—
|
|
Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History
Surgery
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History
Salicylic acid
|
1 Participants
|
12 Participants
|
6 Participants
|
—
|
|
Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History
Other
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 45 weeksPopulation: mITT - Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)
Outcome measures
| Measure |
Pooled Placebo
n=2 Participants
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=26 Participants
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=7 Participants
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts
Naive
|
2 Number of warts
|
11 Number of warts
|
3 Number of warts
|
—
|
|
The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts
Cryotherapy
|
0 Number of warts
|
13 Number of warts
|
4 Number of warts
|
—
|
|
The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts
Surgery
|
0 Number of warts
|
0 Number of warts
|
0 Number of warts
|
—
|
|
The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts
Salicylic Acid
|
0 Number of warts
|
7 Number of warts
|
2 Number of warts
|
—
|
|
The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts
Other
|
0 Number of warts
|
0 Number of warts
|
0 Number of warts
|
—
|
Adverse Events
Pooled Placebo
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Cohort 1
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Cohort 2
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Cohort 3
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pooled Placebo
n=43 participants at risk
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=45 participants at risk
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=40 participants at risk
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=41 participants at risk
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis, Acute
|
0.00%
0/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.4%
1/41 • Number of events 1 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Infections and infestations
Brain Abcess
|
0.00%
0/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.5%
1/40 • Number of events 1 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Infections and infestations
Mediastinal Abcess
|
0.00%
0/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.5%
1/40 • Number of events 1 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.5%
1/40 • Number of events 1 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
Other adverse events
| Measure |
Pooled Placebo
n=43 participants at risk
0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
|
Cohort 1
n=45 participants at risk
0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 2
n=40 participants at risk
0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
Cohort 3
n=41 participants at risk
0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
37.2%
16/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
33.3%
15/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
37.5%
15/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
56.1%
23/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.9%
9/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
31.1%
14/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
35.0%
14/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
31.7%
13/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
General disorders
Fatigue
|
34.9%
15/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
26.7%
12/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
35.0%
14/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
31.7%
13/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Gastrointestinal disorders
Diarrhoea
|
16.3%
7/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
28.9%
13/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
22.5%
9/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
22.0%
9/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Gastrointestinal disorders
Nausea
|
7.0%
3/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
13.3%
6/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
22.5%
9/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
26.8%
11/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Infections and infestations
Influenza
|
20.9%
9/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
8.9%
4/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
15.0%
6/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
31.7%
13/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.7%
2/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
4.4%
2/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
15.0%
6/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
4.9%
2/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.7%
2/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
4.4%
2/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
5.0%
2/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
14.6%
6/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
General disorders
Influenza Like Illness
|
4.7%
2/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
11.1%
5/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.5%
1/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
4.9%
2/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.2%
1/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
10.0%
4/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
7.3%
3/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Infections and infestations
Sinusitis
|
2.3%
1/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.2%
1/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
5.0%
2/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
9.8%
4/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
1/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.2%
1/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
7.5%
3/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.4%
1/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
General disorders
Pyrexia
|
7.0%
3/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
5.0%
2/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
7.3%
3/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
3/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.2%
1/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
5.0%
2/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.4%
1/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Infections and infestations
Urinary Tract Infection
|
4.7%
2/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.2%
1/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
5.0%
2/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.4%
1/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Nervous system disorders
Migraine
|
0.00%
0/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
2.2%
1/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
5.0%
2/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.3%
1/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
5.0%
2/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/43 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/45 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
5.0%
2/40 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
0.00%
0/41 • Events during or after the first wart injection through the last visit, up to 45 weeks
Incidence of Treatment Emergent, Non-Injection Site Reactions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place