Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Uterine Cervical Neoplasms

Warts

Condylomata Acuminata

Urogenital Diseases

Genital Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

All Drugs and Chemicals

Vaccines

Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha)

Placebo

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 18-45 Years .

A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females

A Multicenter,Randomized, Placebo-Controlled, and Double-blind Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Aged 18-45 Years

Subjects with solicited and unsolicited AEs

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA) , Live infant, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth, Lost to follow up and Pregnancy ongoing.

Shanghai Bovax Biotechnology Co., Ltd.

Rare Diseases

Vulvar Neoplasms

Vulvar Diseases

Disease Attributes

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

Anti-Infective Agents

Antineoplastic Agents

Artesunate

Artemisinins

Artemisinin

Artenimol

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Antiviral Agents

Anthelmintics

Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks

Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks

topical ointment, as a non-surgical treatment

Artesunate ointment

Placebo ointment

Mihaela Plesa

Ahmad Bayat, MD

Edward C. Grendys, MD FACOG, FACS

Donna White

Megan Park

Chad Michener, MD

Mariam AlHilli, MD

Steven Waggonner, MD

Robert DeBernardo, MD

Roberto Vargas, MD

Lindsey Beffa, MD

Johanna Kelley, MD

Daniel Margul, MD

Michelle Kuznicki, MD

This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.

Double-blind, placebo-controlled randomized trial

This study is only for biological females

Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)

Number of participants who have complete histologic response following topical artesunate ointment

Number of participants who achieve clearance of HPV genotypes present at screening. These genotypes become undetectable over the study window.

Number of participants with documented partial response following topical artesunate

Number of participants with documented complete response who do not have recurrence of their vulvar HSIL over the study window

Number of participants who report artesunate-related serious adverse events

The Cleveland Clinic

Frantz Viral Therapeutics, LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females	NCT05584332	Cervical Cancer Genital Wart CIN1 CIN2 CIN3 Vain I Vain III Vin I Vin II Vin III AIS VAIN - Vaginal ...	Quadrivalent Hu... Placebo	18 Years - 45 Years	Shanghai Bovax Biotechnology Co., Ltd.
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)	NCT06075264	Vulvar Diseases HPV Infection Vulvar HSIL Pre-Cancerous D... HPV Disease VIN, Usual Type VIN 2 of Usual ... VIN 3 of Usual ... Vin II Vin III VIN Grade 2 VIN Grade 3 High Grade Intr...	Artesunate oint... Placebo ointmen...	18 Years -	Frantz Viral Therapeutics, LLC

Spots Global Cancer Trial Database for vin ii

Every month we try and update this database with for vin ii cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vin ii

Every month we try and update this database with for vin ii cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vin ii cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.