The effect of hydrogen purification on skin condition in women with acne vulgaris
| ISRCTN | ISRCTN13842359 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13842359 |
| Secondary identifying numbers | KB/54/NOZ/2019 |
- Submission date
- 26/11/2019
- Registration date
- 09/12/2019
- Last edited
- 17/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
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
Contact information
Public
Opole Medical School
Katowicka 68
Opole
45-060
Poland
 ORCID ID |
0000-0002-6435-0179 |
|---|---|
| Phone | +48 665439443 |
| karolina.chilicka@poczta.onet.pl |
Study information
| Study design | Prospective clinical study with follow-up analysis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | http://wsm.opole.pl/1/strona-glowna.html |
| Scientific title | The effect of hydrogen purification on selected skin parameters of healthy women and suffering from acne vulgaris |
| 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(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 06/05/2019 |
| Overall study end date | 25/02/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 80 participants |
| Total final enrolment | 60 |
| Participant inclusion criteria | 1. Female aged 19 years or above 2. Group A: acne vulgaris 3. Group B: healthy skin |
| 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
Study participating centre
Opole
45-060
Poland
Sponsor information
University/education
Katowicka 68
Opole
45-060
Poland
| Phone | +48 (0)774423546 |
|---|---|
| snw@wsm.opole.pl | |
| Website | http://wsm.opole.pl/1/strona-glowna.html |
"ROR" |
https://ror.org/000bjk220 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publications in peer-reviewed journals. Protocol and data will be available on the study website. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2021 | 17/02/2021 | Yes | No |
Editorial Notes
17/02/2021: Publication reference added.
13/03/2020: The intention to publish date has been changed from 01/06/2020 to 01/08/2020.
02/03/2020: The total final enrolment was added.
27/11/2019: Trial’s existence confirmed by Research Ethics Committee from Opole Medical School.
