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

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.

Study Overview

• Status: Unknown
• Conditions: Vulva Intraepithelial Nonneoplastic
• Intervention / Treatment: 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).

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250031
      • Recruiting
      • Jinan Military General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• patients with clinically and biopsy confirmed non-neoplastic lesions of genital skin and mucous membrane (non-neoplasia epithelial disorders of skin and mucosa of vulva).

Symptoms include repeated itching, discoloration, rhagades, loss of skin elasticity and dyspareunia that affect the patients' quality of life.

Exclusion criteria:

• atypical hyperplasia or vulvar cancer confirmed by biopsy of genital lesions;
• vulvovaginal or other gynecological trauma, acute inflammatory diseases and other acute illness in need of urgent care;
• combined with other serious gynecological diseases (symptomatic hysteromyoma, ovarian tumor, etc.), and/or severe organ diseases (such as heart, lung, brain and renal disease/failure) that need immediate treatment;
• other type of cancers that require urgent care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grading changes of nonneoplastic epithelial disorders from colposcopy and biopsy pathology	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.	One month before treatment and 2,4,6 weeks and 2,6,12,24 monthes after treatment

Collaborators and Investigators

• Sponsor: Jinan Military General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 14, 2015
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Anti-Bacterial Agents; Anti-Infective Agents; Chitosan
• Other Study ID Numbers: JNJQ201408