Condition category
Skin and Connective Tissue Diseases
Date applied
03/01/2020
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
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

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

15/02/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/01/2020: Trial’s existence confirmed by Opole Medical School