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CompletedNCT05770245Updated Apr 25, 2024

Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis

An interventional study of The novel electrolyzed water spray in Dermatophytoses, sponsored by Dove Medical Press Ltd. Completed at 1 site in China. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by Dove Medical Press Ltd · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

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. This study uses this novel electrolyzed water device and the water spray to treat mild dermatophytosis.

02

Conditions studied

  • Dermatophytoses

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Keywords

  • Electrolyzed water device
  • Hydroxyl radical
  • Tap water
  • Spray
  • Dermatophytosis
  • Itching
03

In context

Tinea

90 studies on the registry are indexed under Tinea; 6 are open to participants now.

This study's enrollment of 14 is below the median of 131 across 84 interventional studies indexed under Tinea.

Browse Tinea studies →

Lead sponsor

Dove Medical Press Ltd is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • severe dermatophytosis.
  • 80 years or older.
  • Pregnant or breastfeeding women.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Mild dermatophytosis and one treatment

    Study staff will use the novel electrolyzed water spray device and spray for approximately 10 minutes on the participant's diseased area until half a bottle (200ml) of water is used.

    Device: The novel electrolyzed water spray

Interventions

  • DeviceThe novel electrolyzed water spray

    The researcher used electrolyzed water or piped water to treat the diseased area two times a day for five days. The trial consists of 7 study visits (day 1-day 7). The reduction in the disease area of discomfort or itching scores and promoting healing of the damaged skin of patients with mild dermatophytosis event assessments will be performed at each visit. Safety analysis will be assessed based on the reports of adverse events during the study.

06

What researchers measure

Primary outcomes

  1. An itching scale made by modifying the Numeric Pain Rating Scale (NPRS)

    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".

    Time frame: 7 days

Secondary outcomes

  1. A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).

    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.

    Time frame: 7 days

07

Study locations

1 site
  • Huinuode Biotechnology Co., Ltd.
    Qingdao, China
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Clinical study report

Time frame: until publication of this clinical study and international patent granted

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Jul 2023, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2023
First posted
Mar 15, 2023
StartActual
Jan 29, 2023
Primary completionActual
Jul 20, 2023
CompletionActual
Feb 1, 2024
Last update
Apr 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05770245
Lead sponsor
Dove Medical Press Ltd
Responsible party
Sponsor
First posted
Mar 15, 2023
Start date
Jan 29, 2023
Primary completion
Jul 20, 2023
Completion
Feb 1, 2024
Last update
Apr 25, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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