Condition category
Skin and Connective Tissue Diseases
Date applied
08/01/2020
Date assigned
17/01/2020
Last edited
17/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://wsm.opole.pl/3210/5723/projekty-badawcze.html

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

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

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

Publication citations

Additional files

Editorial Notes

08/01/2020: Trial’s existence confirmed by Opole Medical School.