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The purpose of this study is to test whether spraying the itching of inflammation skin and groin patients by use of the novel electrolyzed water spray will produce improvement in the condition of 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 mild senile groin eczema, neurodermatitis and psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The mild senile groin eczema, neurodermatitis and psoriasis and one treatment | Experimental | Participants with itching of mild senile groin eczema, neurodermatitis and psoriasis 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 5 minutes on the participant's diseased area until half a bottle (200ml) of water is used. The patients use electrolyzed water to treat the diseased area, two times a day, for 10 days. The trial consists of 10 study visits (day 1-day 10). The relief of mild senile groin eczema, neurodermatitis and psoriasis 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 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 itching. A higher score means a worse outcome. 0 means "no itching " and 10 means "the most itching". | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS). | The signs of skin chronic inflammation include darkness or redness, swelling and dryness and broken surface and reduced area of the diseased skin. This Score is based on descriptions of signs of senile groin eczema, neurodermatitis and psoriasis rated 0-10 to assess the condition of mild inflammation of the skin and groin. A higher score means a worse outcome. |
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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 |
|---|---|
| D009450 | Neurodermatitis |
| D011565 | Psoriasis |
| D004485 | Eczema |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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An open label, single arm and before and after treatment comparison study
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|
| 10 days |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |