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

Not Applicable
Completed
Conditions
Scalp Dermatoses
Interventions
Device: A novel electrolyzed water spray
Registration Number
NCT05765526
Lead Sponsor
Dove Medical Press Ltd
Brief Summary

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.

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. 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • The patients with scalp discomfort or itching
Exclusion Criteria
  • severe scalp discomfort or itching; 80 years or elder

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
The scalp of discomfort or itching and one treatmentA novel electrolyzed water sprayParticipants with discomfort or itching scalp who will receive one treatment with the device and complete the questionnaire.
Primary Outcome Measures
NameTimeMethod
A discomfort or itching scale made by modifing a pain scale (NPRS)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".

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Huinuode Biotechnology Co., Ltd.

🇨🇳

Qingdao, China

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