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OpenTrials
Completed

NCT Number: NCT05765526

A Novel Electrolyzed Water Spray Treatment for the Discomfort or Itching of Patients With Scalp

The purpose of this study is to test whether the reduction of the discomfort or itching with the scalp of patients by use of the novel electrolyzed water spray will produce improvement in the condition of the scalp.

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Key information

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huinuode Biotechnology Co., Ltd.

Qingdao, China

About this study

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. In this study, this novel electrolyzed water device and the water spray are used to treat scalp itching. The reduction in the scalp of discomfort or 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients with scalp discomfort or itching

Exclusion criteria

  • severe scalp discomfort or itching; 80 years or elder

Treatment and study plan

A novel electrolyzed water spray

Device

Study staff will use the novel electrolyzed water spray device and spray for approximately 10 minutes on the participant's scalp until half bottle (200ml) of water is used. Their scalp will then be rinsed and gently dried with a towel.

Primary outcomes

  1. A discomfort or itching scale made by modifing a pain scale (NPRS)

    Time frame: 5 days

    This Score is based on descriptions of the discomfort or itching that patients rate 0-10 to assess the condition of their scalp. A higher score means a worse outcome. 0 means "no discomfort or itching " and 10 means "the most discomfort or itching".

Sponsors and collaborators

Lead sponsor

Dove Medical Press Ltd

Network

Registry information

Official study title

A Novel Electrolyzed Water Spray Reduces Discomfort or Itching Scores of Patients With Scalp Discomfort or Itching: A Clinical Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 13, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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