Impact of ultrasound to increase medication absorption on skin health and quality of life of acne patients
| ISRCTN | ISRCTN98261720 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98261720 |
| Secondary identifying numbers | KB/59/NOZ/2019 |
- Submission date
- 03/01/2020
- Registration date
- 17/01/2020
- Last edited
- 20/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Public
Opole Medical School
Opole
45-060
Poland
 ORCID ID |
0000-0002-6435-0179 |
|---|---|
| Phone | 665439443 |
| karolina.chilicka@poczta.onet.pl |
Study information
| Study design | Prospective clinical study with follow-up analysis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | http://wsm.opole.pl/download/attachment/30539/about-the-project.pdf |
| Scientific title | Impact of sonophoresis using a seboregulating ampoule on selected skin parameters and the quality of life acne patients |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/05/2019 |
| Completion date | 20/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Female aged 19-23 years 2. Acne vulgaris |
| Key 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 |
| Date of first enrolment | 04/02/2020 |
| Date of final enrolment | 18/02/2020 |
Locations
Countries of recruitment
- Poland
Study participating centre
Opole
7542744054
Poland
Sponsor information
University/education
Katowicka 68
Opole
45-060
Poland
| Phone | +48 (0)774423546 |
|---|---|
| snw@wsm.opole.pl | |
| Website | http://wsm.opole.pl/1/strona-glowna.html |
"ROR" |
https://ror.org/000bjk220 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 15/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publications in peer-reviewed journals. |
| IPD sharing plan | The 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 | 05/04/2022 | 20/04/2022 | Yes | No |
Editorial Notes
20/04/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
22/04/2020: The overall end date was changed from 18/06/2020 to 20/12/2020.
07/01/2020: Trial’s existence confirmed by Opole Medical School
