van der Linden 2017.
Trial name or title | Topical 5% imiquimod cream for vulva Paget's disease: clinical efficacy, safety and immunological response |
Methods | Interventional open‐label Phase 3 trial |
Participants | Women aged ≥ 18 years with non‐invasive vulval Paget's disease, primary or recurrence after earlier surgery. |
Interventions | Imiquimod topical 5% imiquimod cream (Aldara) 3 times a week for 16 weeks Paracetamol Lidocaine in Vaseline ointment |
Outcomes | Clinical response will be assessed by vulval examination and measurement and defined as complete remission, partial remission (decrease by ≥ 50% of total lesion size) or no remission. |
Starting date | May 2015 |
Contact information | Joanne A de Hullu, MD, PhD; University Medical Center Nijmegen, the Netherlands |
Notes |