Condition category
Skin and Connective Tissue Diseases
Date applied
05/05/2020
Date assigned
28/05/2020
Last edited
28/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

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.

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

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

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

Publication citations

Additional files

Editorial Notes

07/05/2020: Trial's existence confirmed by Public Higher Medical Professional School in Opole.