Plain English Summary
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.
Acne medication applied to the skin may have its efficacy improved by the use of high frequency soundwaves (ultrasound) that may increase absorption of the medication by the skin cells. This technique is known as sonophoresis.
This study aims to investigate the effect of sonophoresis on acne treatment.
Who can participate?
Female volunteers aged 19 – 23 years, who suffer with acne vulgaris.
What does the study involve?
Participants will undergo five sessions of sonophoresis performed every seven days using a seboregulating ampoule or placebo gel. Before the treatment series, a 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?
Benefits: oiling and amount of skin efflorescence will be lower, the moisture of skin will be higher, quality of life will be better after treatments,
No risks
Where is the study run from?
Opole Medical School, Poland
When is the study starting and how long is it expected to run for?
February 2020 to June 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/download/attachment/30539/about-the-project.pdf
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
665439443
karolina.chilicka@poczta.onet.pl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
KB/59/NOZ/2019
Study information
Scientific title
Impact of sonophoresis using a seboregulating ampoule on selected skin parameters and
the quality of life acne patients
Acronym
Study hypothesis
1. Sonophoresis decreases the oiling of the skin
2. Sonophoresis increases the quality of life
3. Sonophoresis acts anti-inflammatory on skin efflorescence
Ethics approval
Approved 13/06/2019, Research Ethics Committee from Opole Medical School (68 Katowicka
Street; 45-065; Poland; +48 774410882; biurorektora@wsm.opole.pl), ref: KB/59/NOZ/2019
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/download/attachment/30539/about-the-project.pdf
Condition
Acne vulgaris
Intervention
Five sessions of sonophoresis with a seboregulating ampoule (Group A) or placebo (Group B) will be made over seven days. After this time skin parameters will be measured (7 and 14 days after finishing the sonophoresis sessions). Skin sebum (oily secretion) level, hydration and pH of skin will be compared. Five sessions will be performed weekly. After all sessions, the follow-up measurements will be made after 7 and 14 days.
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. Parameters of skin will be checked like: oiling of skin, moisturising and pH. Measurements will be made between the eyebrows, 1 cm from the wing of the nose and 1 cm from the lower lip (in the chin area).
Intervention type
Device
Phase
Not Applicable
Drug names
Sonophoresis device made by Hebe, Poland (http://www.hebenet.pl/peeling.php)
Seboregulating ampoule (contains: aqua, green tea extract, bambusa vulgaris (bamboo) extract, lactic acid, thymus vulgaris extract, mimose extract, carbomer, caprylyl glycol, sal maris)
Primary outcome measure
Skin sebum content measured using the SebumeterⓇ at baseline, one-week and two-weeks after finishing the treatments
Secondary outcome measures
1. Skin hydration measured using a CorneometerⓇ at baseline, one-week and two-weeks after finishing the treatments
2. Transepidermal pH measured using Skin-pH-Meter at baseline, one-week and 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
15/05/2019
Overall trial end date
18/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female aged 19-23 years
2. Acne vulgaris
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant 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. Cancer/tumour
11. Heart problems (peacemaker)
12. Implants (metal, silicone, saline)
13. Skin allegry
14. Active tuberculosis
Recruitment start date
04/02/2020
Recruitment end date
18/02/2020
Locations
Countries of recruitment
Poland
Trial participating centre
Opole Medical School
Katowicka 68
Opole
7542744054
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
15/02/2021
Participant level data
Available on request
Basic results (scientific)
Publication list