Condition category
Skin and Connective Tissue Diseases
Date applied
26/11/2019
Date assigned
09/12/2019
Last edited
13/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://wsm.opole.pl/1/strona-glowna.html

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

Total final enrolment

60

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

http://wsm.opole.pl/1/strona-glowna.html

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

01/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.