Trial · NCT02596074
Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN
NCT02596074, Phase 2, Completed, Maruho Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN. Trials, record NCT02596074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02596074
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN
- NCT number
- NCT02596074
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Maruho Co., Ltd.
- Conditions
- Usual Type Vulval Intraepithelial Neoplasia (uVIN)
- Interventions
- Omiganan (CLS001) topical gel, Vehicle topical gel
- First posted
- 2015-11-04
- Last updated
- 2017-08-03
- Other registries' IDs
- eudract:2015-002724-16
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacodynamics (HPV Viral Load Assessment) | 24 Weeks | Assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies |
| Primary | Pharmacodynamics (Local Immunity Status) | 24 Weeks | Histological changes in immune cells in the mucosa/submucosa |
| Primary | Clinical Assessment (Lesions by RECIST) | 24 Weeks | Efficacy assessment of lesions by RECIST |
| Primary | Clinical Assessment (Percent clearance of Lesions) | 24 Weeks | Efficacy assessment of percent clearance of lesions |
| Primary | Clinical Assessment (Sum of the longest diameter (SLD)) | 24 Weeks | Efficacy assessment of the sum of the longest diameter (SLD)) |
| Primary | Clinical Assessment (Histology) | 24 Weeks | Efficacy assessment of the histology (regression of uVIN to no dysplasia) |
| Secondary | Safety and Tolerability (Adverse Events) | 48 Weeks | Adverse Events will be collected throughout the study |
| Secondary | Safety and Tolerability (Laboratory Safety Testing) | 48 Weeks | Laboratory Samples will be collected throughout the study |
| Secondary | Safety and Tolerability (12-Lead ECGs) | 48 Weeks | 12-Lead ECGs will be performed throughout the study |
| Secondary | Safety and Tolerability (Vital Signs) | 48 Weeks | Vital Signs will be collected throughout the study |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31755993 | DERIVED |
Source PubMed
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/NCT02596074
GET https://conductscience.org/api/trials/v1/NCT02596074/registered