Plain English Summary
Background and study aims
Hydrogen, a natural element with unusual properties, introduced into the skin with the help of a device, primarily slows down the aging process by neutralizing oxygen free radicals, has anti-inflammatory and cleansing effects. The aim of the test is to check how the hydrogen cleansing treatment will affect the skin parameters such as pH, hydration and oiling in healthy and acne vulgaris group.
Who can participate?
Healthy young Polish female volunteers with mild to moderate acne vulgaris or with healthy skin, aged 19-25
What does the study involve?
Hydrogen cleansing will be performed on the cleansed face skin, using a special plastic tip that sucks the skin fold and at the same time washing it with hydrogen water (created thanks to the generator in the device). After all sessions, the follow-up measurements will be made after 7 and 14 days.
What are the possible benefits and risks of participating?
Benefits: Improved skin health.
Risks: There is no possibile risks of participating, only after treatment skin is a little bit red, but after 10 minutes it stops, it is very safe treatment.
Where is the study run from?
Opole Medical School - Faculty of Health Science (Poland)
When is the study starting and how long is it expected to run for?
January 2020 to February 2020
Who is funding the study?
Opole Medical School (Poland)
Who is the main contact?
Dr Karolina Chilicka
karolina.chilicka@poczta.onet.pl
Trial website
Contact information
Type
Public
Primary contact
Dr Karolina Chilicka
ORCID ID
https://orcid.org/0000-0002-6435-0179
Contact details
Opole Medical School
Katowicka 68
Opole
45-060
Poland
+48 665439443
karolina.chilicka@poczta.onet.pl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
KB/54/NOZ/2019
Study information
Scientific title
The effect of hydrogen purification on selected skin parameters of healthy women and suffering from acne vulgaris
Acronym
Study hypothesis
1. Hydrogen purification decreases the oiling of skin
2. Hydrogen purification increases the moisture of skin
3. Hydrogen purification acts anti-inflammatory on skin efflorescence
Ethics approval
Approved 13/06/2019, Research Ethics Committee from Opole Medical School (68 Katowicka Street; 45-065; Poland; +48 774410882; biurorektora@wsm.opole.pl), ref: KB/54/NOZ/2019
Study design
Prospective clinical study with follow-up analysis
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
http://wsm.opole.pl/1/strona-glowna.html
Condition
Acne vulgaris
Intervention
Participants are recruited into 2 groups:
1st group - healthy women (lower level of sebum)
2nd group - women from mild to moderate acne vulgaris (higher level of sebum)
Other parameters also will be checked: pH and skin hydration. Measurements will be made between the eyebrows, 1 cm from the wing of the nose and 1 cm from the lower lip (in the chin area).
Four sessions of hydrogen purification are performed weekly. After this time skin parameters will be measured (7 and 14 days after finishing the hydrogen purification sessions). Skin sebum (oily secretion) level, hydration and pH of skin will be compared between these two groups. Hydrogen cleansing will be performed on the cleansed face skin, using a special plastic tip that sucks the skin fold and at the same time washing it with hydrogen water (created thanks to the generator in the device). After all sessions, the follow-up measurements will be made after 7 and 14 days.
Intervention type
Device
Phase
Not Applicable
Drug names
Hydrogen purification
Primary outcome measure
Skin sebum content measured using the SebumeterⓇ at baseline, one-week and two-weeks after finishing the treatments
Secondary outcome measures
1. Skin hydration measured using a CorneometerⓇ at baseline, one-week and two-weeks after finishing the treatments
2. Transepidermal pH measured using Skin-pH-Meter at baseline, one-week and two-weeks after finishing the treatments
3. General quality of life of patients with acne vulgaris measured using the Hellgren and Vincent Scale at baseline and two weeks after finishing the treatments
Overall trial start date
06/05/2019
Overall trial end date
25/02/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female aged 19 years or above
2. Group A: acne vulgaris
3. Group B: healthy skin
Participant type
Mixed
Age group
Adult
Gender
Female
Target number of participants
80 participants
Participant exclusion criteria
Exclusion criteria for group A (acne vulgaris):
1. Severe acne
2. Pregnancy, lactation
3. Active inflammation of the skin
4. Bacterial, viral, allergic and fungal relapsing skin diseases
5. Disturbed skin continuity
6. Fresh surgical procedures in the treatment area
7. Active herpes
8. Treatment with isotretinoin
9. Reduced immunity
10. Epilepsy
11. Claustrophobia
Exclusion criteria for group B (healthy):
1. Pregnancy, lactation
2. Active inflammation of the skin
3. Bacterial, viral, allergic and fungal relapsing skin diseases
4. Disturbed skin continuity
5. Fresh surgical procedures in the treatment area
6. Active herpes
7. Reduced immunity
8. Epilepsy
9. Claustrophobia
Recruitment start date
07/01/2020
Recruitment end date
07/01/2020
Locations
Countries of recruitment
Poland
Trial participating centre
Opole Medical School
Katowicka 68
Opole
45-060
Poland
Sponsor information
Organisation
Opole Medical School
Sponsor details
Katowicka 68
Opole
45-060
Poland
+48 (0)774423546
snw@wsm.opole.pl
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Opole Medical School
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publications in peer-reviewed journals.
Protocol and data will be available on the study website.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
01/06/2020
Participant level data
Available on request
Basic results (scientific)
Publication list