The impact of treatments using cosmetic acids on the skin of people suffering from acne vulgaris
| ISRCTN | ISRCTN79716614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79716614 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | KB/16/2018 |
| Sponsor | Public Higher Medical Professional School in Opole |
| Funder | Opole Medical School |
- Submission date
- 08/01/2020
- Registration date
- 17/01/2020
- Last edited
- 14/07/2022
- 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
Cosmetic acids are a procedure that can be used for people suffering from acne vulgaris. Both pyruvic acid and azelaic acid can be used for treatments that are aimed at reducing skin greasiness, as well as reducing skin porosity.
The aim of the test is to check how both acids will affect skin parameters, quality of life and if one of these cosmetic acids will be better for acne vulgaris skin.
Who can participate?
Polish female volunteers with mild to moderate acne vulgaris or with healthy skin, aged 18-25
What does the study involve?
Cosmetic acids will be performed on the cleansed face skin, using a cotton stick, then neutralizer will be put on the skin, and rinsed by cold water.
After all the sessions, the follow-up measurements will be made after 14 days.
What are the possible benefits and risks of participating?
Benefits: Improved skin health.
Risks: There is no possible risks of participating, only after treatment skin is a little bit red, but after 1-2 hours it stops.
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 April 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
Opole
45-060
Poland
 ORCID ID |
0000-0002-6435-0179 |
|---|---|
| Phone | +48 665439443 |
| karolina.chilicka@poczta.onet.pl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective clinical study with follow-up analysis |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | The impact of treatments using pyruvic and azelaic acids on selected skin parameters and quality of life from people suffering from acne vulgaris |
| Study objectives | 1. Treatment with cosmetic acids decreases the oiling of skin 2. Treatment with cosmetic acids increases the quality of life 3. Treatment with cosmetic acids acts anti-inflammatory on skin efflorescence |
| Ethics approval(s) | Approved 13/03/2018, Research Ethics Committee from Opole Medical School (68 Katowicka Street; 45-065; Poland; +48 774410882; biurorektora@wsm.opole.pl), ref: KB/16/2018 |
| Health condition(s) or problem(s) studied | Acne vulgaris |
| Intervention | Participants are recruited into 2 groups: 1st group - treatment with pyruvic acid 2nd group - treatment with azelaic acid Parameters of the skin will be chececked like: oiling, moisturising, poriosity, peeling by device Nati Skin Analyzer. Six sessions of cosmetic acids are performed every two weeks. After this time skin parameters will be measured (14 days after last session). Skin parameters will be compared between these two groups. Cosmetic acids will be performed on the cleansed face skin, using a cotton stick that, then neutralizer will be used and rinsed by a cold water. After all sessions, the follow-up measurements will be made after 14 days. Also quality of life will be checked into this two groups, before and after finishing all sessions. DLQI and Skindex-29 will be used. |
| Intervention type | Drug |
| Phase | |
| Drug / device / biological / vaccine name(s) | Pyruvic and Azelaic Acids |
| Primary outcome measure(s) |
Skin sebum content measured using the Nati Skin Analyzer at baseline, and two-weeks after finishing the treatments. |
| Key secondary outcome measure(s) |
1. Skin moisture measured using NAti Skin Analyzer at baseline, two-weeks after finishing the treatments |
| Completion date | 20/04/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Female |
| Target sample size at registration | 120 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Female aged 18-25 years 2. Acne vulgaris |
| Key exclusion criteria | 1. Severe acne 2. Pregnancy, lactation 3. Active inflammation of the skin 4. Bacterial, viral, allergic and dungal 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. Cancer/tumour 11. Skin allegry |
| Date of first enrolment | 27/01/2020 |
| Date of final enrolment | 31/01/2020 |
Locations
Countries of recruitment
- Poland
Study participating centre
Opole
45-060
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | 28/07/2020 | 31/07/2020 | Yes | No |
| Results article | 27/07/2020 | 14/07/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/07/2022: Publication reference added.
31/07/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
08/01/2020: Trial’s existence confirmed by Opole Medical School.
