Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Dr Karolina Chilicka
ORCID ID
https://orcid.org/0000-0002-6435-0179
Contact details
Opole Medical School
Opole
45-060
Poland
+48 665439443
karolina.chilicka@poczta.onet.pl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
KB/16/2018
Study information
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
Acronym
Study hypothesis
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
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
Study design
Prospective clinical study with follow-up analysis
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
http://wsm.opole.pl/3210/5723/projekty-badawcze.html
Condition
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 names
Pyruvic and Azelaic Acids
Primary outcome measure
Skin sebum content measured using the Nati Skin Analyzer at baseline, and two-weeks after finishing the treatments.
Secondary outcome measures
1. 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 trial start date
08/01/2018
Overall trial end date
20/04/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female aged 18-25 years
2. Acne vulgaris
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant 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
Recruitment start date
27/01/2020
Recruitment end date
31/01/2020
Locations
Countries of recruitment
Poland
Trial participating centre
Opole Medical School
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
Opole Medical School
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 available from the corresponding author on reasonable request.
Intention to publish date
08/06/2020
Participant level data
Available on request
Basic results (scientific)
Publication list