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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the high intensity focused ultrasound (Mianyang Sonic electronic LLC) | Device |
| ||
| Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel). |
| 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 |
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Inclusion criteria:
Symptoms include repeated itching, discoloration, rhagades, loss of skin elasticity and dyspareunia that affect the patients' quality of life.
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geping Yin, M.D. | Contact | 86-0531-51666230 | ygpwylll@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Military General Hospital | Recruiting | Jinan | Shandong | 250031 | China |
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| Drug |
|
| ID | Term |
|---|---|
| C001716 | formaldehyde, meta-cresolsulfonic acid drug combination |
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