Trial Outcomes & Findings for A Phase 3 Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts (NCT NCT02971891)
NCT ID: NCT02971891
Last Updated: 2023-09-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
484 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)
CLS006 (Furosemide) Topical Gel applied once daily CLS006 (Furosemide) Topical Gel, 0.125%
|
Vehicle
Vehicle Topical Gel applied once daily Vehicle Topical Gel
|
|---|---|---|
|
Overall Study
STARTED
|
246
|
238
|
|
Overall Study
Subjects Who Had 1 Wart
|
118
|
117
|
|
Overall Study
Subjects Who Had 2 Warts
|
56
|
53
|
|
Overall Study
Subjects Who Had 3 Warts
|
24
|
24
|
|
Overall Study
Subjects Who Had 4 Warts
|
21
|
12
|
|
Overall Study
Subjects Who Had 5 Warts
|
12
|
11
|
|
Overall Study
Subjects Who Had 6 Warts
|
15
|
21
|
|
Overall Study
COMPLETED
|
229
|
214
|
|
Overall Study
NOT COMPLETED
|
17
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
Baseline characteristics by cohort
| Measure |
CLS006 (Furosemide)
n=246 Participants
CLS006 (Furosemide) Topical Gel, 0.125%
|
Vehicle
n=238 Participants
Vehicle Topical Gel
|
Total
n=484 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.6 years
STANDARD_DEVIATION 16.40 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 16.57 • n=7 Participants
|
28.8 years
STANDARD_DEVIATION 16.47 • n=5 Participants
|
|
Age, Customized
>=2 to <12
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Customized
>=12 to <18
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age, Customized
>=18 to <65
|
158 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Age, Customized
>=65
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
205 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
226 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
447 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
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 18Outcome measures
| Measure |
CLS006 (Furosemide)
n=229 Participants
CLS006 (Furosemide) Topical Gel, 0.125%
|
Vehicle
n=214 Participants
Vehicle Topical Gel
|
|---|---|---|
|
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
|
32 Participants
|
24 Participants
|
|
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
|
197 Participants
|
190 Participants
|
SECONDARY outcome
Timeframe: Week 18Outcome measures
| Measure |
CLS006 (Furosemide)
n=229 Participants
CLS006 (Furosemide) Topical Gel, 0.125%
|
Vehicle
n=214 Participants
Vehicle Topical Gel
|
|---|---|---|
|
The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject
|
0.178 ratio of cleared warts
Standard Deviation 0.3636
|
0.145 ratio of cleared warts
Standard Deviation 0.3334
|
SECONDARY outcome
Timeframe: Week 12Outcome measures
| Measure |
CLS006 (Furosemide)
n=229 Participants
CLS006 (Furosemide) Topical Gel, 0.125%
|
Vehicle
n=214 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
|
14 Participants
|
|
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12.
Not complete clearance of all treated warts
|
208 Participants
|
200 Participants
|
SECONDARY outcome
Timeframe: Week 12Outcome measures
| Measure |
CLS006 (Furosemide)
n=229 Participants
CLS006 (Furosemide) Topical Gel, 0.125%
|
Vehicle
n=214 Participants
Vehicle Topical Gel
|
|---|---|---|
|
The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12
|
0.120 ratio of cleared warts
Standard Deviation 0.3041
|
0.087 ratio of cleared warts
Standard Deviation 0.2601
|
SECONDARY outcome
Timeframe: Week 18Outcome measures
| Measure |
CLS006 (Furosemide)
n=229 Participants
CLS006 (Furosemide) Topical Gel, 0.125%
|
Vehicle
n=214 Participants
Vehicle Topical Gel
|
|---|---|---|
|
Change From Baseline in Wart Size for Each Subject
|
-2.5 mm
Standard Deviation 7.13
|
-2.4 mm
Standard Deviation 6.64
|
Adverse Events
CLS006 (Furosemide)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CLS006 (Furosemide)
n=246 participants at risk
CLS006 (Furosemide) Topical Gel, 0.125%
|
Vehicle
n=238 participants at risk
Vehicle Topical Gel
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
5/246 • 18 weeks
|
0.84%
2/238 • 18 weeks
|
|
Nervous system disorders
Headache
|
1.2%
3/246 • 18 weeks
|
1.3%
3/238 • 18 weeks
|
|
Infections and infestations
Sinusitis
|
0.41%
1/246 • 18 weeks
|
1.7%
4/238 • 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