Trial · NCT01861535
Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
NCT01861535, Phase 3, Completed, Medical University of Graz
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia. Trials, record NCT01861535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01861535
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
- NCT number
- NCT01861535
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 110 participants, actual
- Lead sponsor
- Medical University of Graz
- Conditions
- Vulvar Intraepithelial Neoplasia
- Interventions
- Imiquimod, Surgery
- First posted
- 2013-05-23
- Last updated
- 2021-04-14
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete clinical response | 6 months | No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size |
| Secondary | Clinical response/ lesion size | 6 months | Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction). |
| Secondary | Histologic response | 6 months | At baseline punch biopsies will be taken from the affected areas. The site of the initial biopsy will be photodocumented to ensure that the follow-up biopsy at 6 months is taken from the same site. Histologic results will be classified as response (R): complete disappearance of usual type VIN or reduction to VIN1,or no response (NR). All biopsy samples will be analysed independently by two experienced gynecologic pathologists unaware of the treatment allocation |
| Secondary | Extent of surgery | 6 months | The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size) |
| Secondary | HPV status | 6 months | HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe. |
| Secondary | Clinical response/lesion size | 12 months | Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction). |
| Secondary | Extent of surgery | 12 months | The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size) |
| Secondary | HPV status | 12 months | HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe. |
| Other | "Cervical Dysplasia Distress" Questionnaire | 6 months | Change from baseline in "Cervical Dysplasia Distress" score at 6 months |
| Other | "Cervical Dysplasia Distress" questionnaire | 12 months | Change from Baseline in "Cervical Dysplasia Distress" score at 12 months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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.
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01861535
GET https://conductscience.org/api/trials/v1/NCT01861535/registered