Trial · NCT02971891
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
NCT02971891, Phase 3, Completed, Maruho Co., Ltd.; results first posted 2023-09-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT02971891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02971891
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT02971891
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 484 participants, actual
- Lead sponsor
- Maruho Co., Ltd.
- Conditions
- Cutaneous Common Warts
- Interventions
- CLS006 (Furosemide) Topical Gel, Vehicle Topical Gel
- First posted
- 2016-11-23
- Last updated
- 2023-09-14
- Results first posted
- 2023-09-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | Week 18 | |
| Secondary | The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject | Week 18 | |
| Secondary | Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | Week 12 | |
| Secondary | The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12 | Week 12 | |
| Secondary | Change From Baseline in Wart Size for Each Subject | Week 18 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Week 18 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject | Week 18 | ratio of cleared warts | MEAN | |
| SECONDARY | Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | Week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12 | Week 12 | ratio of cleared warts | MEAN | |
| SECONDARY | Change From Baseline in Wart Size for Each Subject | Week 18 | mm | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | CLS006 (Furosemide) | Achieved complete clearance of all treated warts | 32 | 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. | Vehicle | Achieved complete clearance of all treated warts | 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. | CLS006 (Furosemide) | Not achieved complete clearance of all treated warts | 197 | 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. | Vehicle | Not achieved complete clearance of all treated warts | 190 | Participants | |
| The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject | CLS006 (Furosemide) | 0.178 | Standard Deviation 0.3636 | ratio of cleared warts | |
| The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject | Vehicle | 0.145 | Standard Deviation 0.3334 | ratio of cleared warts | |
| Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | CLS006 (Furosemide) | Complete clearance of all treated warts | 21 | Participants | |
| Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | Vehicle | Complete clearance of all treated warts | 14 | Participants | |
| Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | CLS006 (Furosemide) | Not complete clearance of all treated warts | 208 | Participants | |
| Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | Vehicle | Not complete clearance of all treated warts | 200 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CLS006 (Furosemide) | 246 | |
| Overall Study | STARTED | Vehicle | 238 | |
| Overall Study | Subjects Who Had 1 Wart | CLS006 (Furosemide) | 118 | |
| Overall Study | Subjects Who Had 1 Wart | Vehicle | 117 | |
| Overall Study | Subjects Who Had 2 Warts | CLS006 (Furosemide) | 56 | |
| Overall Study | Subjects Who Had 2 Warts | Vehicle | 53 | |
| Overall Study | Subjects Who Had 3 Warts | CLS006 (Furosemide) | 24 | |
| Overall Study | Subjects Who Had 3 Warts | Vehicle | 24 | |
| Overall Study | Subjects Who Had 4 Warts | CLS006 (Furosemide) | 21 | |
| Overall Study | Subjects Who Had 4 Warts | Vehicle | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | CLS006 (Furosemide) | 5 | 246 | |
| other | Upper respiratory tract infection | Infections and infestations | Vehicle | 2 | 238 | |
| other | Headache | Nervous system disorders | CLS006 (Furosemide) | 3 | 246 | |
| other | Headache | Nervous system disorders | Vehicle | 3 | 238 | |
| other | Sinusitis | Infections and infestations | CLS006 (Furosemide) | 1 | 246 | |
| other | Sinusitis | Infections and infestations | Vehicle | 4 | 238 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CLS006 (Furosemide) | 0 | 246 |
| Total, all-cause mortality | Vehicle | 0 | 238 |
| Total, other adverse events | CLS006 (Furosemide) | 9 | 246 |
| Total, other adverse events | Vehicle | 9 | 238 |
| Total, serious adverse events | CLS006 (Furosemide) | 0 | 246 |
| Total, serious adverse events | Vehicle | 0 | 238 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CLS006 (Furosemide) vs Vehicle: deaths from any cause | Trial comparisons |
| CLS006 (Furosemide) vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02971891
GET https://conductscience.org/api/trials/v1/NCT02971891/registered