Trial · NCT03259620

A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts

NCT03259620, 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 Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts. Trials, record NCT03259620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03259620

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT03259620
Status: Completed
Phases: Phase 3
Enrollment: 491 participants, actual
Lead sponsor: Maruho Co., Ltd.
Conditions: Cutaneous Common Warts
Interventions: CLS006, CLS006 Vehicle
First posted: 2017-08-23
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
Primary	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	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 the Number of Cleared Warts Out of the Number of 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	Units	Measured as
PRIMARY	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	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 the Number of Cleared Warts Out of the Number of 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
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	CLS006	Achieved complete clearance of all treated warts	35		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	CLS006 Vehicle	Achieved complete clearance of all treated warts	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	CLS006	Not achieved complete clearance of all treated warts	191		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	CLS006 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		0.210	Standard Deviation 0.3771	Ratio of Cleared Warts
The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject	CLS006 Vehicle		0.191	Standard Deviation 0.3500	Ratio of Cleared Warts
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12	CLS006	Complete clearance of all treated warts	21		Participants
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12	CLS006 Vehicle	Complete clearance of all treated warts	19		Participants
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12	CLS006	Not complete clearance of all treated warts	205		Participants
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12	CLS006 Vehicle	Not complete clearance of all treated warts	198		Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CLS006	245
Overall Study	STARTED	CLS006 Vehicle	246
Overall Study	Subjects Who Had 1 Wart	CLS006	112
Overall Study	Subjects Who Had 1 Wart	CLS006 Vehicle	118
Overall Study	Subjects Who Had 2 Warts	CLS006	48
Overall Study	Subjects Who Had 2 Warts	CLS006 Vehicle	40
Overall Study	Subjects Who Had 3 Warts	CLS006	25
Overall Study	Subjects Who Had 3 Warts	CLS006 Vehicle	31
Overall Study	Subjects Who Had 4 Warts	CLS006	13
Overall Study	Subjects Who Had 4 Warts	CLS006 Vehicle	18

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events24

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
other	Nausea	Gastrointestinal disorders	CLS006	5	245
other	Nausea	Gastrointestinal disorders	CLS006 Vehicle	0	246
other	Upper respiratory tract infection	Infections and infestations	CLS006	5	245
other	Upper respiratory tract infection	Infections and infestations	CLS006 Vehicle	4	246
other	Nasopharyngitis	Infections and infestations	CLS006	4	245
other	Nasopharyngitis	Infections and infestations	CLS006 Vehicle	3	246
other	Influenza	Infections and infestations	CLS006	3	245
other	Influenza	Infections and infestations	CLS006 Vehicle	2	246
other	Pharyngitis streptococcal	Infections and infestations	CLS006	3	245
other	Pharyngitis streptococcal	Infections and infestations	CLS006 Vehicle	2	246

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CLS006	1	245
Total, all-cause mortality	CLS006 Vehicle	1	246
Total, other adverse events	CLS006	23	245
Total, other adverse events	CLS006 Vehicle	14	246
Total, serious adverse events	CLS006	3	245
Total, serious adverse events	CLS006 Vehicle	3	246

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 vs CLS006 Vehicle: deaths from any cause	Trial comparisons
CLS006 vs CLS006 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03259620

GET https://conductscience.org/api/trials/v1/NCT03259620/events?page=2

API reference For AI assistants