Trial · NCT02385188
Topical 5% Imiquimod Cream for Vulvar Paget's Disease
NCT02385188, Phase 3, Completed, University Medical Center Nijmegen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topical 5% Imiquimod Cream for Vulvar Paget's Disease. Trials, record NCT02385188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02385188
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical 5% Imiquimod Cream for Vulvar Paget's Disease
- NCT number
- NCT02385188
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- University Medical Center Nijmegen
- Conditions
- Paget Disease, Extramammary
- Interventions
- Imiquimod, paracetamol, lidocaine in Vaseline ointment
- First posted
- 2015-03-11
- Last updated
- 2020-01-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical response | 12 weeks after the end of treatment | Clinical response will be assessed by vulvar examination and measurement and is defined as complete remission, partial remission (decrease by ≥50% of total lesion size) or no remission. |
| Secondary | Tolerability questionnaire | 4, 10 and 16 weeks after the start of treatment | Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions: 1. Have you used paracetamol during treatment? 1. How many days? 2. What dosage? 3. Was the use sufficient? 2. Have you used lidocaine in Vaseline ointment during treatment? 1. How many days? 2. What dosage? 3. Was the use sufficient? 3. Have you stopped the treatment with imiquimod because of side effects/pain? |
| Secondary | Adverse events | 4, 10 and 16 weeks after the start of treatment | Most common adverse events will be evaluated with the following questions: 1. Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily. 2. Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily. 3. Have you felt more tired than you normally are? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily. |
| Secondary | Immunological response | Baseline, 4 and 28 weeks after start of treatment | Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of |
| Secondary | Quality of life: general. | Baseline, 4 and 28 weeks after start of treatment. | The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used. |
| Secondary | Quality of life: dermatology specific. | Baseline, 4 and 28 weeks after start of treatment. | The questionnaire DLQI (Dermatology Life Quality Index) will be used. |
| Secondary | Quality of life: sexuality. | Baseline, 4 and 28 weeks after start of treatment. | The questionnaire FSDS (Female Sexual Distress Scale) will be used. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers2
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/NCT02385188
GET https://conductscience.org/api/trials/v1/NCT02385188/registered