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The purpose of this study is to test whether spraying the skin of patients of patients by use of the novel electrolyzed water spray will produce improvement in the condition of mild dermatophytosis.
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 mild dermatophytosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild dermatophytosis and one treatment | Experimental | Study staff will use the novel electrolyzed water spray device and spray for approximately 10 minutes on the participant's diseased area until half a bottle (200ml) of water is used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The novel electrolyzed water spray | Device | The researcher used electrolyzed water or piped water to treat the diseased area two times a day for five days. The trial consists of 7 study visits (day 1-day 7). The reduction in the disease area of discomfort or itching scores and promoting healing of the damaged skin of patients with mild dermatophytosis 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 the Numeric Pain Rating Scale (NPRS) | This Score is based on descriptions of the itching that patients rate 0-10 to assess the condition of their mild dermatophytosis. A higher score means a worse outcome. 0 means "no itching " and 10 means "the most itching". | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS). | The skin signs scale evaluates the disease-damaged skin replaced by fresh and healthy skin. This Score is based on descriptions of darkness or redness, swelling and dryness, broken surface, and reduced diseased skin area patients rate 0-10. A higher score means a worse outcome. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|
| D014005 | Tinea |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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An open label, single arm and before and after treatment comparison study
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|
| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |