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Vulvar Diseases clinical trials

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NCT ID: NCT06075264 Recruiting - HPV Infection Clinical Trials

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

ART-VIN IIB
Start date: December 6, 2023
Phase: Phase 2
Study type: Interventional

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).

NCT ID: NCT06070454 Not yet recruiting - Vaginitis Clinical Trials

Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions

Start date: November 14, 2023
Phase: N/A
Study type: Interventional

Primary: - To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision - To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.

NCT ID: NCT05890092 Recruiting - Vulvar Diseases Clinical Trials

Vulvar Disease in Nigeria Observational Study

VdiN
Start date: May 3, 2023
Phase:
Study type: Observational [Patient Registry]

Vulvar disease in Nigeria A look at awareness within patients and health practitioners, self-reported and actual prevalence within communities in Nigeria

NCT ID: NCT05592626 Recruiting - Neoplasms Clinical Trials

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

START-001
Start date: January 4, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

NCT ID: NCT05478746 Completed - Vulvodynia Clinical Trials

Effects of Flourish HEC on Localized Provoked Vulvodynia

Start date: September 26, 2022
Phase: N/A
Study type: Interventional

This study is designed to determine whether improving the vaginal microbiome in women with localized provoked vulvodynia (LPV) may help improve pain better than routine care alone. The study randomizes women with LPV to either routine care or routine care plus a vaginal hygiene system designed to improve the vaginal microbiome. Women will be assessed for vaginal microbiome, vaginal pH, and pain before enrollment and after 6 weeks, and after 3 months. Women will also have pain assessed 2 weeks after enrollment without assessing vaginal microbiome and pH.

NCT ID: NCT03792516 Active, not recruiting - Vulvar Diseases Clinical Trials

Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)

ART-VIN
Start date: April 17, 2019
Phase: Phase 1
Study type: Interventional

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).

NCT ID: NCT03444727 Terminated - Anesthesia Clinical Trials

Treatment Prior to Injection and Biopsy of the Vulva

Start date: February 19, 2018
Phase: N/A
Study type: Interventional

This study will compare pre-treatment with ice prior to injection of local anesthetic for vulvar biopsy to no pre-treatment and evaluate pain levels and patient satisfaction with the procedure.

NCT ID: NCT03200808 Completed - Clinical trials for Nonneoplastic Epithelial Disorders of Vulva

Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva

NNEDsMB
Start date: October 1, 2013
Phase: Phase 1
Study type: Interventional

The aim of this study is to demonstrate the safety and effectiveness of mixed methylene blue compound Injection for the treatment of nonneoplastic epithelial disorders(NNEDS) of vulva. NNEDS of skin and mucosa of vulva refer to a group of chronic diseases including squamous hyperplasia and lichen sclerosus, which mainly cause vulvar itching and hypopigmentation. Usually the itching is severe may influence social activities and sleep. In addition, NNEDS cause scarring of the vulva which may cause significant sexual dysfunction or pain. The reasons for NNEDs are not clear and the methods of treatment are diverse. The current treatments are primarily local drug (e.g. steroid, calcineurin inhibitors, immunosuppressive agents ), surgical treatments, laser or photodynamic therapy, and the "gold standard" treatment for lichen sclerosus is potent steroids creams. However, all the treatments are not good enough, and the diseases often recur and severely affect women's quality of life. So the investigators reviewed plenty of literatures, and found some authors used single intradermal 1% methylene blue injection for intractable idiopathic pruritus ani and the effect was good. As a preliminary experiment, the investigators used intradermal mixed methylene blue compound injection for a NNEDs patient in the year of 2012, the itching of the patient stopped immediately and the color of the vulva recovered 6 months later. The patient keeps healthy till now. And from then on, the investigators designed this study and to verify the effect and complications of intradermal mixed methylene blue compound injection for the treatment of NNEDS. So far, there is no similar study reported internationally.

NCT ID: NCT02881229 Terminated - Vulvodynia Clinical Trials

Vulvar Mucosal Specialty Clinic Chart Review

Start date: April 2016
Phase:
Study type: Observational

This study aims to develop a clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in management of vulvar disease.

NCT ID: NCT02858310 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

Start date: January 27, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers caused by HPV have a HPV protein called E7 inside of their cells. In this new therapy, researchers take a person s blood, remove certain white blood cells, and insert genes that make them to target cancer cells that have the E7 protein. The genetically changed cells, called E7 TCR cells, are then given back to the person to fight the cancer. Researchers want to see if this can help people. Objective: To determine a safe dose and efficacy of E7 TCR cells and whether these cells can help patients. Eligibility: Adults ages 18 and older with an HPV-16-associated cancer, including cervical, vulvar, vaginal, penile, anal, or oropharyngeal. Design: Participants will list all their medicines. Participants will have many screening tests, including imaging procedures, heart and lung tests, and lab tests. They will have a large catheter inserted into a vein. Participants will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. The cells will be changed in the lab. Participants will stay in the hospital. Over several days, they will get: Chemotherapy drugs E7 TCR cells Shots or injections to stimulate the cells Participants will be monitored in the hospital up to 12 days. They will get support medicine and have blood and lab tests. Participants will have a clinic visit about 40 days after cell infusion. They will have a physical exam, blood work, scans, and maybe x-rays. Participants will have many follow-up visits with the same procedures. At some visits, they may undergo leukapheresis. Participants will be followed for 15 years.