Vulvar Diseases Clinical Trial
Official title:
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)
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).
Phase I open-label dose escalation study of topical artesunate, formulated as ointment, in the treatment of adult females with biopsy-confirmed HSIL VIN2/3. Fifteen (15) subjects will undergo up to a total of three cycles of topical artesunate. The first cycle will be initiated on Day 0, the second at Week 2, and the third and final cycle at week 4. Primary Objective: To evaluate the safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions To measure the effect of artesunate ointment on histologic regression of HSIL/VIN2/3 to VIN1 or less, confirmed by a colposcopically-directed biopsy, at study week 15. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05478746 -
Effects of Flourish HEC on Localized Provoked Vulvodynia
|
N/A | |
Not yet recruiting |
NCT06070454 -
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
|
N/A | |
Recruiting |
NCT05890092 -
Vulvar Disease in Nigeria Observational Study
|
||
Completed |
NCT00004316 -
Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
|
Phase 1/Phase 2 | |
Recruiting |
NCT05592626 -
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT02858310 -
E7 TCR T Cells for Human Papillomavirus-Associated Cancers
|
Phase 1/Phase 2 | |
Terminated |
NCT03444727 -
Treatment Prior to Injection and Biopsy of the Vulva
|
N/A | |
Recruiting |
NCT06075264 -
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
|
Phase 2 | |
Completed |
NCT00496184 -
Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis
|
Phase 3 | |
Recruiting |
NCT00119886 -
Botox on Vulvar Vestibulitis
|
Phase 4 |