NCT02890277

Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound

Treatment of Nonneoplastic Epithelial Disorders of Skin and Mucosa of Vulva With High Intensity Focused Ultrasound

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Jinan Military General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic diseases shown as female genital skin and mucosal tissue degeneration and pigmentation change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug or surgical treatments. However, the effect is not good enough, but the diseases often recur and severely affect patients' quality of life. In this study, the investigators combined the technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug to treat. The data from colposcopy and biopsy pathology were collected before and after treatment to create the objective identifying degree of the disease by with "grading methods" and evaluate the treatment effect. At the meantime, the standardized treatment procedure, methods and efficacy criterion were all stipulated to achieve satisfactory results, which could be used to clinical treatments. So far, the investigators have not seen similar study reported internationally.

Conditions

• Vulva Intraepithelial Nonneoplastic

Interventions

Type	Name	Description
DEVICE	the high intensity focused ultrasound (Mianyang Sonic electronic LLC)
DRUG	Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel).

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-09-07
• Last updated: 2017-01-13

Locations

1 site across 1 country: China