Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts (NCT NCT03259620)
NCT ID: NCT03259620
Last Updated: 2023-09-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
491 participants
Primary outcome timeframe
Week 18
Results posted on
2023-09-14
Participant Flow
Subjects must have 1 to 6 clearly identifiable common warts located on hands, feet, limbs, and/or trunk
Participant milestones
| Measure |
CLS006
Furosemide Topical Gel applied once daily Furosemide Topical Gel, 0.125%
|
CLS006 Vehicle
Vehicle Topical Gel applied once daily Vehicle Topical Gel
|
|---|---|---|
|
Overall Study
STARTED
|
245
|
246
|
|
Overall Study
Subjects Who Had 1 Wart
|
112
|
118
|
|
Overall Study
Subjects Who Had 2 Warts
|
48
|
40
|
|
Overall Study
Subjects Who Had 3 Warts
|
25
|
31
|
|
Overall Study
Subjects Who Had 4 Warts
|
13
|
18
|
|
Overall Study
Subjects Who Had 5 Warts
|
20
|
20
|
|
Overall Study
Subjects Who Had 6 Warts
|
27
|
19
|
|
Overall Study
COMPLETED
|
226
|
217
|
|
Overall Study
NOT COMPLETED
|
19
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
Baseline characteristics by cohort
| Measure |
CLS006
n=245 Participants
Furosemide Topical Gel, 0.125%
|
CLS006 Vehicle
n=246 Participants
Vehicle Topical Gel
|
Total
n=491 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 18.80 • n=5 Participants
|
30.2 years
STANDARD_DEVIATION 17.26 • n=7 Participants
|
31.1 years
STANDARD_DEVIATION 18.05 • n=5 Participants
|
|
Age, Customized
>=2 to <12
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Customized
>=12 to <18
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Customized
>=18 to <65
|
150 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Age, Customized
>=65
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
198 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
375 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
219 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
430 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 18Outcome measures
| Measure |
CLS006
n=226 Participants
Furosemide Topical Gel, 0.125%
|
CLS006 Vehicle
n=217 Participants
Vehicle Topical Gel
|
|---|---|---|
|
The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation
Achieved complete clearance of all treated warts
|
35 Participants
|
27 Participants
|
|
The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation
Not achieved complete clearance of all treated warts
|
191 Participants
|
190 Participants
|
SECONDARY outcome
Timeframe: Week 18Outcome measures
| Measure |
CLS006
n=226 Participants
Furosemide Topical Gel, 0.125%
|
CLS006 Vehicle
n=217 Participants
Vehicle Topical Gel
|
|---|---|---|
|
The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject
|
0.210 Ratio of Cleared Warts
Standard Deviation 0.3771
|
0.191 Ratio of Cleared Warts
Standard Deviation 0.3500
|
SECONDARY outcome
Timeframe: Week 12Outcome measures
| Measure |
CLS006
n=226 Participants
Furosemide Topical Gel, 0.125%
|
CLS006 Vehicle
n=217 Participants
Vehicle Topical Gel
|
|---|---|---|
|
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12
Complete clearance of all treated warts
|
21 Participants
|
19 Participants
|
|
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12
Not complete clearance of all treated warts
|
205 Participants
|
198 Participants
|
SECONDARY outcome
Timeframe: Week 12Outcome measures
| Measure |
CLS006
n=226 Participants
Furosemide Topical Gel, 0.125%
|
CLS006 Vehicle
n=217 Participants
Vehicle Topical Gel
|
|---|---|---|
|
The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12
|
0.135 ratio of cleared warts
Standard Deviation 0.3112
|
0.127 ratio of cleared warts
Standard Deviation 0.3020
|
SECONDARY outcome
Timeframe: Week 18Outcome measures
| Measure |
CLS006
n=226 Participants
Furosemide Topical Gel, 0.125%
|
CLS006 Vehicle
n=217 Participants
Vehicle Topical Gel
|
|---|---|---|
|
Change From Baseline in Wart Size for Each Subject
|
-3.5 mm
Standard Deviation 7.10
|
-3.1 mm
Standard Deviation 6.84
|
Adverse Events
CLS006
Serious events: 3 serious events
Other events: 23 other events
Deaths: 1 deaths
CLS006 Vehicle
Serious events: 3 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CLS006
n=245 participants at risk
Furosemide Topical Gel, 0.125%
|
CLS006 Vehicle
n=246 participants at risk
Vehicle Topical Gel
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.41%
1/245 • 18 weeks
|
0.00%
0/246 • 18 weeks
|
|
Cardiac disorders
Cardiomyopathy
|
0.41%
1/245 • 18 weeks
|
0.00%
0/246 • 18 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.41%
1/245 • 18 weeks
|
0.00%
0/246 • 18 weeks
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/245 • 18 weeks
|
0.41%
1/246 • 18 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/245 • 18 weeks
|
0.41%
1/246 • 18 weeks
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/245 • 18 weeks
|
0.41%
1/246 • 18 weeks
|
Other adverse events
| Measure |
CLS006
n=245 participants at risk
Furosemide Topical Gel, 0.125%
|
CLS006 Vehicle
n=246 participants at risk
Vehicle Topical Gel
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.0%
5/245 • 18 weeks
|
0.00%
0/246 • 18 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
5/245 • 18 weeks
|
1.6%
4/246 • 18 weeks
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
4/245 • 18 weeks
|
1.2%
3/246 • 18 weeks
|
|
Infections and infestations
Influenza
|
1.2%
3/245 • 18 weeks
|
0.81%
2/246 • 18 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.2%
3/245 • 18 weeks
|
0.81%
2/246 • 18 weeks
|
|
Infections and infestations
Sinusitis
|
1.2%
3/245 • 18 weeks
|
1.2%
3/246 • 18 weeks
|
Additional Information
Maruho Co.,Ltd. Kyoto R&D Center
Clinical Development Dept.
Phone: +81-75-325-3255
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place