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
Secondary identifying numbers KB/16/2018
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Study website

Contact information

Dr Karolina Chilicka
Public

Opole Medical School
Opole
45-060
Poland

ORCiD logoORCID ID 0000-0002-6435-0179
Phone +48 665439443
Email karolina.chilicka@poczta.onet.pl

Study information

Study designProspective clinical study with follow-up analysis
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeTreatment
Participant information sheet http://wsm.opole.pl/3210/5723/projekty-badawcze.html
Scientific titleThe impact of treatments using pyruvic and azelaic acids on selected skin parameters and quality of life from people suffering from acne vulgaris
Study objectives1. 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) studiedAcne vulgaris
InterventionParticipants 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 typeDrug
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)Pyruvic and Azelaic Acids
Primary outcome measureSkin sebum content measured using the Nati Skin Analyzer at baseline, and two-weeks after finishing the treatments.
Secondary outcome measures1. Skin moisture measured using NAti Skin Analyzer at baseline, two-weeks after finishing the treatments
2. Poriosity and peeling of skin will be measured by Nati Skin Analyzer at baseline two-weeks after finishing the treatments
3. General quality of life of patients with acne vulgaris measured using the Hellgren and Vincent Scale and also Skindex-29 and DLQI questionnaries at baseline and two weeks after finishing the treatments
Overall study start date08/01/2018
Completion date20/04/2020

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit25 Years
SexFemale
Target number of participants120
Total final enrolment120
Key inclusion criteria1. Female aged 18-25 years
2. Acne vulgaris
Key exclusion criteria1. 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 enrolment27/01/2020
Date of final enrolment31/01/2020

Locations

Countries of recruitment

  • Poland

Study participating centre

Opole Medical School
Katowicka 68
Opole
45-060
Poland

Sponsor information

Public Higher Medical Professional School in Opole
University/education

Katowicka 68
Opole
45-060
Poland

Phone +48 (0)774423546
Email snw@wsm.opole.pl
Website http://wsm.opole.pl/1/strona-glowna.html
ROR logo "ROR" https://ror.org/000bjk220

Funders

Funder type

University/education

Opole Medical School

No information available

Results and Publications

Intention to publish date08/06/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublications in peer-reviewed journals.
IPD sharing planThe 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

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.