N/A
Completed N=8
Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
Source: ClinicalTrials.gov NCT00504023 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
May 2018
Primary outcomePrimary: Percentage of Participants With Clinical and Histologic Remission — 75 % of participants
Summary
RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Applying topical imiquimod to the vulva may be an effective treatment for recurrent Paget's disease.
PURPOSE: This clinical trial is studying how well topical imiquimod works in treating patients with recurrent Paget's disease of the vulva.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical and Histologic Remission |
75 | — |
Eligibility Criteria
Inclusion Criteria
All patients presenting to the Gynecology outpatient service at a participating institution who meet eligibility requirements may be included in this clinical trial. The eligibility requirements are as follows:
- Age ≥18.
- Ability to give informed consent.
- Patients must have biopsy proven recurrent extramammary Paget's disease confirmed at the participating site.
Exclusion Criteria
- Patients with known hypersensitivity to imiquimod.
- Pregnant and nursing women are not eligible
- Patients with underlying adenocarcinoma on biopsy of lesion confirmed at the participating site.
Data sourced from ClinicalTrials.gov (NCT00504023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.