Trial · NCT02462187
Topical NVN1000 for the Treatment of External Genital and Perianal Warts
NCT02462187, Phase 2, Completed, Novan, Inc.; results first posted 2023-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topical NVN1000 for the Treatment of External Genital and Perianal Warts. Trials, record NCT02462187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02462187
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical NVN1000 for the Treatment of External Genital and Perianal Warts
- NCT number
- NCT02462187
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- Novan, Inc.
- Conditions
- Genital Warts, Perianal Warts
- Interventions
- NVN1000 8% Gel, NVN1000 16%, Vehicle, NVN1000 24%
- First posted
- 2015-06-03
- Last updated
- 2023-04-06
- Results first posted
- 2023-04-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | 12 weeks | Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator. |
| Secondary | Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch | Baseline, Week 2, Week 4, Week 8, Week 12 | Comparison of scores for erythema, edema, erosions/ulcers, itch between active and vehicle treated subjects using a 4 point grading scale; on the tolerability scale, 0 = none and 3 = severe, indicating an increase in severity the higher the number assigned. |
| Secondary | Safety as Determined by Changes in Laboratory Assessments | Baseline, Week 2 and Week 12 | Safety population--Comparison of changes in methemoglobin levels between active and vehicle treated subjects. Methemoglobin levels were measured using a RAD-57 pulse co-oximeter. Values are expressed as a percentage of hemoglobin. |
| Secondary | Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12 | 12 weeks | The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator |
| Secondary | Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12 | 12 weeks | Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator |
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 | Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | 12 weeks | ITT population. One subject in the NVN1000 8% Gel BID group was randomized but not dispensed treatment and thus was excluded from the ITT population.. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch | Baseline, Week 2, Week 4, Week 8, Week 12 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety as Determined by Changes in Laboratory Assessments | Baseline, Week 2 and Week 12 | Safety population | Percentage | MEAN |
| SECONDARY | Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12 | 12 weeks | Intent to treat (ITT) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12 | 12 weeks | Intent to treat (ITT) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group636
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | Cohort 1: NVN1000 8% Gel Twice Daily | 2 | Participants | ||
| Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | Cohort 2: NVN1000 8% Gel Once Daily | 5 | Participants | ||
| Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | Cohort 3: NVN1000 16% Once Daily | 2 | Participants | ||
| Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | Cohort 4: NVN1000 24% Once Daily | 10 | Participants | ||
| Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | Vehicle Gel Once Daily | 1 | Participants | ||
| Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | Vehicle Gel Twice Daily | 2 | Participants | ||
| Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch | Cohort 1: NVN1000 8% Gel Twice Daily | Erythema: Baseline / 0 (none) | 12 | Participants | |
| Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch | Cohort 2: NVN1000 8% Gel Once Daily | Erythema: Baseline / 0 (none) | 23 | Participants | |
| Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch | Cohort 3: NVN1000 16% Once Daily | Erythema: Baseline / 0 (none) | 14 | Participants | |
| Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch | Cohort 4: NVN1000 24% Once Daily | Erythema: Baseline / 0 (none) | 27 | Participants |
1 to 10 of 636Source ClinicalTrials.gov
See all 636 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: NVN1000 8% Gel Twice Daily | 13 | |
| Overall Study | STARTED | Cohort 2: NVN1000 8% Gel Once Daily | 24 | |
| Overall Study | STARTED | Cohort 3: NVN1000 16% Once Daily | 14 | |
| Overall Study | STARTED | Cohort 4: NVN1000 24% Once Daily | 30 | |
| Overall Study | STARTED | Vehicle Gel Once Daily | 23 | |
| Overall Study | STARTED | Vehicle Gel Twice Daily | 4 | |
| Overall Study | COMPLETED | Cohort 1: NVN1000 8% Gel Twice Daily | 8 | |
| Overall Study | COMPLETED | Cohort 2: NVN1000 8% Gel Once Daily | 19 | |
| Overall Study | COMPLETED | Cohort 3: NVN1000 16% Once Daily | 9 | |
| Overall Study | COMPLETED | Cohort 4: NVN1000 24% Once Daily | 23 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events180
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 | Application Site Burn | General disorders | Cohort 1: NVN1000 8% Gel Twice Daily | 1 | 12 | 1 |
| other | Application Site Burn | General disorders | Cohort 2: NVN1000 8% Gel Once Daily | 0 | 23 | 0 |
| other | Application Site Burn | General disorders | Cohort 3: NVN1000 16% Once Daily | 0 | 14 | 0 |
| other | Application Site Burn | General disorders | Cohort 4: NVN1000 24% Once Daily | 0 | 30 | 0 |
| other | Application Site Burn | General disorders | Vehicle Gel Once Daily | 0 | 20 | 0 |
| other | Application Site Burn | General disorders | Vehicle Gel Twice Daily | 0 | 4 | 0 |
| other | Application Site Erosion | General disorders | Cohort 1: NVN1000 8% Gel Twice Daily | 1 | 12 | 1 |
| other | Application Site Erosion | General disorders | Cohort 2: NVN1000 8% Gel Once Daily | 0 | 23 | 0 |
| other | Application Site Erosion | General disorders | Cohort 3: NVN1000 16% Once Daily | 0 | 14 | 0 |
| other | Application Site Erosion | General disorders | Cohort 4: NVN1000 24% Once Daily | 2 | 30 | 3 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: NVN1000 8% Gel Twice Daily | 0 | 12 |
| Total, all-cause mortality | Cohort 2: NVN1000 8% Gel Once Daily | 0 | 23 |
| Total, all-cause mortality | Cohort 3: NVN1000 16% Once Daily | 0 | 14 |
| Total, all-cause mortality | Cohort 4: NVN1000 24% Once Daily | 0 | 30 |
| Total, all-cause mortality | Vehicle Gel Once Daily | 0 | 20 |
| Total, all-cause mortality | Vehicle Gel Twice Daily | 0 | 4 |
| Total, other adverse events | Cohort 1: NVN1000 8% Gel Twice Daily | 9 | 12 |
| Total, other adverse events | Cohort 2: NVN1000 8% Gel Once Daily | 13 | 23 |
| Total, other adverse events | Cohort 3: NVN1000 16% Once Daily | 5 | 14 |
| Total, other adverse events | Cohort 4: NVN1000 24% Once Daily | 7 | 30 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02462187
GET https://conductscience.org/api/trials/v1/NCT02462187/results?page=2