Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis

Not Applicable

Completed

• Conditions: Dermatophytoses

• Registration Number: NCT05770245
• Lead Sponsor: Dove Medical Press Ltd

Brief Summary

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.

Detailed 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 dermatophytosis.

Study Timeline

• Study Start: 2023-01-29
• Status Verified: 2023-02
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-05
• Study First Posted: 2023-03-15
• Primary Completion: 2023-07-20
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• mild dermatophytosis accompanied by significant itching symptom
• Patient > 18 years old.

Exclusion Criteria

• severe dermatophytosis.
• 80 years or older.
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
An itching scale made by modifying the Numeric Pain Rating Scale (NPRS)	7 days	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".

Secondary Outcome Measures

Name	Time	Method
A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).	7 days	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.

Trial Locations

Locations (1)

Huinuode Biotechnology Co., Ltd.; 🇨🇳 Qingdao, China