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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05770271
Other study ID # jia19960129
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 29, 2023
Est. completion date January 20, 2024

Study information

Verified date February 2023
Source Dove Medical Press Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date January 20, 2024
Est. primary completion date July 20, 2023
Accepts healthy volunteers No
Gender All
Age group 35 Years to 55 Years
Eligibility Inclusion Criteria: - mild senile groin eczema, neurodermatitis and psoriasis. Exclusion Criteria: - severe senile groin eczema, neurodermatitis and psoriasis. - people with cognitive disorders. - 80 years or older.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
The novel electrolyzed water spray
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.

Locations

Country Name City State
China Huinuode Biotechnology Co., Ltd. Qingdao

Sponsors (1)

Lead Sponsor Collaborator
Dove Medical Press Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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. 10 days
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