Clinical trial · Interventional
Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)
A Phase I Proof-of-Concept Study of Artesunate Ointment for the Treatment of Patients With High-Grade Vulvar Intraepithelial Neoplasia (HSIL VIN 2/3)
NCT03792516CI-TRIAL-00083321ART-VINcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV-Related Vulvar Intraepithelial Neoplasia | — | UNRESOLVED | — |
| Preinvasive Vulvar Disease | — | UNRESOLVED | — |
| Vulva Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | ALIAS | 0.90 |
| Vulvar Diseases | — | UNRESOLVED | — |
| Vulvar Dysplasia | Vulvar Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| artesunate ointment 40% | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Artesunate ointment 40%, 1 cycle
- description
- Patients enrolled in this treatment group will receive one 5-day cycle of artesunate ointment applied topically to the vulva at week 0.
- interventionNames
- Drug: artesunate ointment 40%
- type
- EXPERIMENTAL
- label
- Artesunate ointment 40%, 2 cycles
- description
- Patients enrolled in this treatment group will receive two 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0 and 2.
- interventionNames
- Drug: artesunate ointment 40%
- type
- EXPERIMENTAL
- label
- Artesunate ointment 40%, 3 cycles
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease. * Females of childbearing potential: negative urine pregnancy test * Ability to provide informed consent * Ability to collaborate with planned follow-up (transportation, compliance history, etc.) * Use of contraception through the study exit visit (week 28) Exclusion Criteria: * Concomitant use of any topical immune modulating agents e.g. imiquimod, Aldara ® * Cluster of differentiation 4 (CD4) count \< 200 at the time of screening for eligibility. * Unable to provide informed consent * Currently receiving systemic chemotherapy or radiation therapy for another cancer. * Pregnant females * Concurrent dermatological disorders involving the vulva (i.e., herpes, ulceration secondary to Crohn's disease) or vulvar dermatosis (i.e., lichen planus, lichen sclerosus, or lichen simplex chronicus); * Women weighing less than 50 kg
References
Publications (0)
Data not yet available
No reference posted for this study.