Trial · NCT05717621
Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN)
NCT05717621, Phase 1, Completed, ViMREX GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN). Trials, record NCT05717621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05717621
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN)
- NCT number
- NCT05717621
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 29 participants, actual
- Lead sponsor
- ViMREX GmbH
- Conditions
- Vulvar Intraepithelial Neoplasia Grade 2, Vulvar Intraepithelial Neoplasia Grade 3
- Interventions
- VTD-101 ointment
- First posted
- 2023-02-08
- Last updated
- 2025-02-11
- Other registries' IDs
- eudract:2022-001834-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determination of the dose that is safe and tolerable (by the assessment of the rate of patients (%) experiencing at least one dose limiting toxicity (DLT)) as part of the determination of the recommended phase 2 dose (RP2D). | 28 days | The primary safety endpoint defined as rate of patients experiencing at least one DLT, will be identified by observing frequency, relation to IMP treatment and severity of specific AEs. |
| Primary | Determination of the dose that is effective (by the assessment of the rate of patients (%) with clinical complete or partial response (cCR/cPR) according to adapted RECIST criteria) as part of the determination of the recommended phase 2 dose (RP2D). | 16 months | The primary efficacy endpoint is defined as proportion (%) of patients who achieved clinical complete or partial response, as assessed by adapted RECIST criteria. (Clinical complete response (cCR) is defined as: Complete visual disappearance of the treated lesion(s) (i.e., 100% reduction in the sum of the longest diameter (SLD) among all treated lesions). Clinical partial response (cPR) is defined as: 30-99% reduction in the SLD among all treated lesions. |
| Secondary | Rate of patients (%) with pathological complete response (pCR) | 4 months | The efficacy will be further characterized by the rate of patients experiencing a pathological complete response of the treated lesion(s) in percent (%). |
| Secondary | Computer-based read-out of clinical response | 16 months | The efficacy will be further characterized by a computer-based read-out of manually annotated total surface area of the lesions (mm2/cm2), which will be followed by grading according to adapted RECIST criteria (cCR: 100% reduction in lesion size, cPR: 30-99% reduction in lesion size, SD: 1-29% reduction in lesion size, PD: ≥20% increase in lesion size). |
| Secondary | Molecular response | 4 months | The efficacy will be further characterized by the molecular response defined as reduction of combined p16INK4a/Ki-67-positive cells within the lesion (or in the region of the initial location of the lesion in case of complete lesion disappearance) and defined as decrease of DNMT1 protein expression in HPV-transformed cells determined by immunohistochemistry. |
| Secondary | Clearance of HPV infection in the reference lesion | 4 months | The efficacy will be further characterized by the analysis of the clearance of HPV infection in the reference lesion, defined as the absence of HPV DNA of the HR-HPV type(s) detected at baseline. |
| Secondary | Disease recurrence in patients | 16 months | The efficacy will be further characterized by determining the presence of recurrent lesions in treated patients. Disease recurrence is defined as the reappearance of lesions that were previously subject to complete clinical response. |
| Secondary | Onset of new lesions | 16 months | The efficacy will be further characterized by determining the presence of new lesions in treated patients. Onset of new lesions is defined as the appearance of new lesion(s) at a distinct vulvar site (i.e., a site different from the treated site(s)). |
| Secondary | Adherence to the treatment plan assessed by drug accountability and patient diaries | 4 months | The efficacy will be further characterized by the adherence of patients to the treatment plan. This will be assessed by IMP drug accountability as well as by self-reporting by patients according to a standardized study-specific questionnaire (paper-based patient diary). |
| Secondary | Further evaluation of safety and tolerability of the treatment by the assessment of adverse events (AEs) according to NCI CTCAE v5.0 | 16 months | The safety and tolerability of the treatment will be further assessed with the help of frequency tables with the number and percentage of patients who experienced the AE by treatment and total. Additionally, AEs will be summarized by seriousness of AE, relationship to the IMP, and grading for all NCI CTC categories (CTCAE v5.0). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
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 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/NCT05717621
GET https://conductscience.org/api/trials/v1/NCT05717621/registered