NCT05765526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 25, 2024

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 27, 2023

Last Update Submit

April 24, 2024

Conditions

Scalp Dermatoses

Keywords

Electrolyzed water deviceHydroxyl radicalTap waterSprayScalp discomfortScalp itching

Outcome Measures

Primary Outcomes (1)

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

    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".

    5 days

Study Arms (1)

The scalp of discomfort or itching and one treatment

EXPERIMENTAL

Participants with discomfort or itching scalp who will receive one treatment with the device and complete the questionnaire.

Device: A novel electrolyzed water spray

Interventions

A novel electrolyzed water sprayDEVICE

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.

The scalp of discomfort or itching and one treatment

Eligibility Criteria

Age40 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patients with scalp discomfort or itching

You may not qualify if:

  • severe scalp discomfort or itching; 80 years or elder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

MeSH Terms

Conditions

Scalp Dermatoses

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: An open label, single arm and before and after treatment
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 13, 2023

Study Start

January 29, 2023

Primary Completion

July 15, 2023

Study Completion

March 1, 2024

Last Updated

April 25, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR
Time Frame
until publication of this clinical study and international patent granted

Locations

CN(1)