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The purpose of this study is to test whether spraying the genitalia of patients by use of the novel electrolyzed water spray will produce improvement in the condition of genitalia itching.
In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U).
This is an open-label, single-arm, and before and after treatment comparison study. This study uses this novel electrolyzed water device and the water spray to treat genital itching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The genital itching and one treatment | Experimental | Participants with itching genitalia will receive one treatment with the device and complete the questionnaire. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The novel electrolyzed water spray | Device | Study staff will use the novel electrolyzed water spray device and spray for approximately 2-4 minutes on the participant's diseased area until half a bottle (20-40ml) of water is used. The patients use electrolyzed water to treat the diseased area, two times a day, for 5 days. The trial consists of 5 study visits (day 1-day 5). The relief genital itching evaluation and adverse event assessments will be performed at each visit. Safety analysis will be assessed based on the reports of adverse events during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| An itching scale made by modifying a pain scale (NPRS) | This Score is based on descriptions of the itching that patients rate 0-10 to assess the condition of their genitalia with itching. A higher score means a worse outcome. 0 means "no itching " and 10 means "the most itching". | 5 days |
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Inclusion Criteria:
Patients with genital itching.
Exclusion Criteria:
Severe genital itching. 80 years or older.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huinuode Biotechnology Co., Ltd. | Qingdao | China |
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until publication of this clinical study and international patent granted
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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An open label, single arm and before and after treatment
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| D013568 | Pathological Conditions, Signs and Symptoms |