Assessment of selected skin parameters and quality of life after cosmetic procedures
| ISRCTN | ISRCTN28257448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28257448 |
| Secondary identifying numbers | KB/57/NOZ/2019 |
- Submission date
- 05/05/2020
- Registration date
- 28/05/2020
- Last edited
- 26/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Public
Public Higher Medical Professional School in Opole
Katowicka 68
Opole
45-060
Poland
 ORCID ID |
0000-0002-6435-0179 |
|---|---|
| Phone | +48 (0)665439443 |
| karolina.chilicka@poczta.onet.pl |
Study information
| Study design | Prospective randomised parallel clinical study with follow-up analysis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | http://wsm.opole.pl/3210/5723/projekty-badawcze-pmwsz-w-opolu.html |
| Scientific title | Assessment of selected skin parameters and quality of life after cosmetic procedures in people with acne vulgaris and oily skin |
| Study objectives | 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(s) | 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/57/NOZ/2019 |
| Health condition(s) or problem(s) studied | 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) 9. Microdermabrasion and cosmetic acids (20 people) (added 28/01/2021) 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. The usg of skin will be performed before and after the treatments, to check the collagen fibres (added 21/09/2020). Also a microbione of the skin will be checked. The sample will be taken by a swab before and after finishing the cosmetic series (added 29/10/2020). 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 |
| 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 study start date | 10/02/2020 |
| Completion date | 21/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Female |
| Target number of participants | 320 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Female aged 18-25 2. Acne vulgaris |
| Key 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 |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 30/10/2020 |
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 | 09/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publications in peer-reviewed journals. |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Oxybrasion | 01/07/2022 | 14/07/2022 | Yes | No |
| Results article | 19/05/2023 | 26/05/2023 | Yes | No |
Editorial Notes
26/05/2023: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
14/07/2022: Publication reference added.
28/01/2021: The intervention has been updated.
29/10/2020: The intervention has been updated.
21/09/2020: The intervention has been updated.
07/09/2020: The intervention has been changed.
27/07/2020: The intervention has been updated.
07/05/2020: Trial's existence confirmed by Public Higher Medical Professional School in Opole.
