Scalp DermatosesNCT05765526
A Novel Electrolyzed Water Spray Treatment for the Discomfort or Itching of Patients With Scalp
A study testing A novel electrolyzed water spray in people with Scalp Dermatoses, run by Dove Medical Press Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Scalp Dermatoses
- What is being tested?
- A novel electrolyzed water spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients with scalp discomfort or itching
Who cannot join
- severe scalp discomfort or itching; 80 years or elder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Electrolyzed Water Spray Reduces Discomfort or Itching Scores of Patients With Scalp Discomfort or Itching: A Clinical Study
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.
Read the 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.
- Conditions
- Scalp Dermatoses
- Being tested
- A novel electrolyzed water spray
- Keywords
- Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Scalp discomfort, Scalp itching
- Medical subject headings
- Scalp Dermatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: A novel electrolyzed water spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start29 Jan 2023
- Primary completion15 Jul 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp DermatosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open label, single arm and before and after treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dove Medical Press Ltd
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765526
- Sponsor's protocol ID
- jia19961125
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Electrolyzed Water Spray Reduces Discomfort or Itching Scores of Patients With Scalp Discomfort or Itching: A Clinical Study
- ClinicalTrials.gov ID
- NCT05765526
- Acronym / sponsor ID
- jia19961125
- Conditions
- Scalp Dermatoses
- Keywords
- Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Scalp discomfort, Scalp itching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dove Medical Press LtdResearch network
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open label, single arm and before and after treatment
| Arm | Type | Receives |
|---|---|---|
| The scalp of discomfort or itching and one treatment | Experimental | Device: A novel electrolyzed water sprayParticipants with discomfort or itching scalp who will receive one treatment with the device and complete the questionnaire. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patients with scalp discomfort or itching
Key exclusion criteria (1 listed)
- severe scalp discomfort or itching; 80 years or elder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A novel electrolyzed water sprayStudy 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. | Device | The scalp of discomfort or itching and one treatment |
Primary outcome
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A novel electrolyzed water spray in people with Scalp Dermatoses, run by Dove Medical Press Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A discomfort or itching scale made by modifing a pain scale (NPRS) (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.