Plain English Summary
Background and study aims
Acne is a common skin condition that affects most people at some point. It causes spots, oily skin and sometimes skin that's hot or painful to touch. The following treatments will be used in the study: carboxytherapy (infusions of carbon dioxide), oxybrasion (exfoliation with oxygen), hydrogen purification (with hydrogen-infused water), and cosmetic acids. Some treatments will be used in a combined manner to check whether it is better to perform one treatment using a device or, for example, combine two types of treatments.
Who can participate?
Female volunteers aged 18 to 25 who suffer with acne vulgaris
What does the study involve?
Six sessions of treatment will be performed with different combinations of carboxytherapy, oxybrasion, cosmetic acids and hydrogen purification. Before the treatment series, 1 week and 14 days after the end of the sessions, skin measurements will be taken and questionnaires will be filled out.
What are the possible benefits and risks of participating?
Possible benefits include reduced skin oiling and efflorescence (redness), higher skin moisture, and better quality of life after treatments. There are no expected risks.
Where is the study run from?
Public Higher Medical Professional School in Opole (Poland)
When is the study starting and how long is it expected to run for?
October 2020 to June 2024
Who is funding the study?
Public Higher Medical Professional School in Opole (Poland)
Who is the main contact?
Dr Karolina Chilicka
karolina.chilicka@poczta.onet.pl
Trial website
http://wsm.opole.pl/3210/5723/projekty-badawcze-pmwsz-w-opolu.html
Contact information
Type
Public
Primary contact
Dr Karolina Chilicka
ORCID ID
https://orcid.org/0000-0002-6435-0179
Contact details
Public Higher Medical Professional School in Opole
Katowicka 68
Opole
45-060
Poland
+48 (0)665439443
karolina.chilicka@poczta.onet.pl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
KB/56,57,58/NOZ/2019
Study information
Scientific title
Assessment of selected skin parameters and quality of life after cosmetic procedures in people with acne vulgaris and oily skin
Acronym
Study hypothesis
1. Cosmetic treatments decrease the oiling of the skin
2. Cosmetic treatments increase the moisture of the skin
3. Cosmetic treatments act anti-inflammatory on skin efflorescence
Ethics approval
Approved 10/03/2019, Research Ethics Committee from Opole Medical School (68 Katowicka
Street; 45-065; Poland; +48 (0)774410882; biurorektora@wsm.opole.pl), ref: KB/56,57,58/NOZ/2019
Study design
Prospective randomised parallel clinical study with follow-up analysis
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
http://wsm.opole.pl/3210/5723/projekty-badawcze-pmwsz-w-opolu.html
Condition
Acne vulgaris
Intervention
Current intervention as of 07/09/2020:
Cosmetic treatments will be performed: hydrogen purification, oxybrasion, cosmetic acids, carboxytherapy. The following comparisons of treatments will be made:
1. Oxybrasion (20 people) - hydrogen purification (20 people)
2. Oxybrasion (20 people) - cosmetic acids (20 people)
3. Hydrogen purification (20 people) - cosmetic acids (20 people)
4. Hydrogen purification and cosmetic acids (20 people) - cosmetic acids (20 people)
5. Oxybrasion and cosmetic acids (20 people) - oxybrasion (20 people)
6. Carboxytherapy (20 people) - carboxytherapy and cosmetic acids (20 people)
7. Carboxytherapy (40 people) - carboxytherapy and hydrogen purification (40 people)
8. Carboxytherapy (20 people) - carboxytherapy and oxybrasion (20 people)
The following parameters will also be checked: oiling, pH and skin hydration, porphyrin measurement, pore size, desquamation. Measurements will be made between the eyebrows, 1 cm from the left and right wing of the nose and 1 cm from the lower lip (in the chin area). Every treatment will be performed over a 14-day interval.
After this time skin parameters will be measured (14 and 30 days after finishing sessions). Skin sebum (oily secretion) level, hydration and pH of skin will be compared between these two groups. Participants will have skin sebum level, hydration, and pH checked using a Sebumeter®, Corneometer®, and skin pH meter respectively. Porphyrin measurement will be taken by Visiopor (Courage Khazaka ), desquamation and pore size by Visioscope PC 35 (Courage Khazaka). Quality of life will be checked by using DLQi and Skindes-29 questionnaires before and after finishing treatments. After all sessions, the follow-up measurements will be made after.
Also questionnaires: COPE, CISS, PH, PKIE, PSS 10, phq9 will be assessed at 14 and 30 days
_____
Previous intervention:
Cosmetic treatments will be performed: hydrogen purification, oxybrasion, cosmetic acids, carboxytherapy. The following comparisons of treatments will be made:
1. Oxybrasion (20 people) - hydrogen purification (20 people)
2. Oxybrasion (20 people) - cosmetic acids (20 people)
3. Hydrogen purification (20 people) - cosmetic acids (20 people)
4. Hydrogen purification and cosmetic acids (20 people) - cosmetic acids (20 people)
5. Oxybrasion and cosmetic acids (20 people) - oxybrasion (20 people)
6. Carboxytherapy (20 people) - carboxytherapy and cosmetic acids (20 people)
7. Carboxytherapy (40 people) - carboxytherapy and hydrogen purification (40 people)
8. Carboxytherapy (20 people) - carboxytherapy and oxybrasion (20 people)
The following parameters will also be checked: oiling, pH and skin hydration. Measurements will be made between the eyebrows, 1 cm from the left and right wing of the nose and 1 cm from the lower lip (in the chin area). Every treatment will be performed over a 14-day interval.
After this time skin parameters will be measured (14 and 30 days after finishing sessions). Skin sebum (oily secretion) level, hydration and pH of skin will be compared between these two groups. Participants will have skin sebum level, hydration, and pH checked using a SebumeterⓇ, CorneometerⓇ, and skin pH meter respectively. Quality of life will be checked by using DLQi and Skindes-29 questionnaires before and after finishing treatments. After all sessions, the follow-up measurements will be made after.
Also questionnaires: COPE, CISS, PH, PKIE, PSS 10, phq9 will be assessed at 14 and 30 days (added 27/07/2020)
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Skin sebum content measured using the SebumeterⓇ at baseline, 1 week and 2 weeks after finishing the treatments
Secondary outcome measures
1. Skin hydration measured using a CorneometerⓇ at baseline, 1 week and 2 weeks after finishing the treatments
2. Transepidermal pH measured using Skin-pH-Meter at baseline, day 14 and 30 after finishing the treatments
3. General quality of life measured using the Hellgren and Vincent scale and also Skindex-29 and DLQI questionnaries at baseline and 2 weeks after finishing the treatments
Overall trial start date
10/02/2020
Overall trial end date
21/06/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female aged 18-25
2. Acne vulgaris
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
320
Participant exclusion criteria
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
Recruitment start date
01/10/2020
Recruitment end date
30/10/2020
Locations
Countries of recruitment
Poland
Trial participating centre
Public Higher Medical Professional School in Opole
Katowicka 68
Opole
45-060
Poland
Sponsor information
Organisation
Public Higher Medical Professional School in Opole
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
Public Higher Medical Professional School in Opole
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publications in peer-reviewed journals.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Karolina Chilicka (karolina.chilicka@poczta.onet.pl).
Intention to publish date
09/09/2024
Participant level data
Available on request
Basic results (scientific)
Publication list