Effect of a cream containing hyaluronic acid and bacterial wall extract on skin bacterial flora in subjects with facial seborrheic dermatitis
| ISRCTN | ISRCTN74021432 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74021432 |
| Secondary identifying numbers | EutrosisDs02/2017 |
- Submission date
- 30/10/2018
- Registration date
- 08/11/2018
- Last edited
- 30/12/2022
- 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
Seborrheic dermatitis (SD) is a common inflammatory skin disease, which commonly involves scalp, the face and sometimes the chest. These body areas are rich in sebaceous glands, which are involved in SD. SD is characterized by redness of the skin, oily skin, and itching. One cause of SD is the overgrowth of a particular type of fungus called Malassezia. Therefore, drugs or creams with anti-fungal activity could be beneficial in the treatment of SD. However, recent data has shown that SD leads to a change in the composition of the bacteria that live on the skin (bacterial skin flora). Some types of bacteria are reduced, whereas the population of other types is greatly increased. This trial aims to look at the effects of a new cream on reducing SD, and its effects on the composition of the bacterial skin flora.
Who can participate?
Adults with seborrheic dermatitis of the face
What does the study involve?
Participants will be provided with the study cream and asked to use it twice daily on their face for 6 weeks. They will have skin swabs taken at the start of the study, during the treatment and at the end of the treatment to evaluate their bacterial skin flora.
What are the possible benefits and risks of participating?
The possible benefit to participants is that the cream may improve their SD symptoms and their bacterial skin flora may be re-balanced. There are no known risks to participants taking part in this study.
Where is the study run from?
Three dermatology clinics in Italy:
1. Tor Vergata University (Rome)
2. Ospedale Le Torrette (Ancona)
3. Poliambulatorio Medica Plus (Modena)
When is the study starting and how long is it expected to run for?
February 2017 to May 2018
Who is funding the study?
Cantabria Labs Difa Cooper (Italy)
Who is the main contact?
Dr Massimo Milani MD
massimo.milani@difacooper.com
Contact information
Scientific
Via Milano 160
Caronno Pertusella
21042
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|---|
| Phone | +39029659031 |
| massimo.milani@difacooper.com |
Study information
| Study design | Interventional prospective multi-center open assessor-blinded non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effects of a cream containing 5% hyaluronic acid conjugated with bacterial wall extract on signs and symptoms and on skin microbiota in subjects with seborrheic dermatitis of the face |
| Study objectives | A facial cream containing hyaluronic acid 5% complexed with a bacterial-wall-derived glycoprotein and peptide glycan complex (GPPG-complex) with a known immunomodulator action can equilibrate the facial microbiota in subjects with seborrheic dermatitis |
| Ethics approval(s) | Institutional Review Board of the Coordinating Center (Tor Vergata University, Rome), 22/02/2017, 18bis/2017 |
| Health condition(s) or problem(s) studied | Seborrheic dermatitis of the face |
| Intervention | Participants will be provided with a cosmetic cream containing hyaluronic acid 5%, bacterial wall ferment, zinc PCA, climbazole, piroctone and glycyrrhetinic acid, to be used twice daily on the face (2 finger tip units (FTU) for each application), once in the morning and once in the evening, for 6 weeks. There will be no follow-up period. |
| Intervention type | Other |
| Primary outcome measure | The Investigator Global Assessment (IGA) is used at the baseline, week 3 and week 6 to assess the following: 1. Erythema 2. Seborrhea 3. Itching |
| Secondary outcome measures | Evolution of superficial facial microbiota in the following areas: 1. Interglabellar 2. Naso-labial fold 3. Mandibular rim This was assessed using 16Sr RNA gene sequencing at the baseline and after 6 weeks. Samples for RNA sequencing were obtained The samples for RNA sequencing were obtained with Dry swabbing . Sample were taken in 3 different areas for each subject: Zone 2 Glabellar ; zone 2: nasolabial fold; Zone 3: mandibular rim. Swabs were stored a -80 C until the tests Dry swab samples of the following areas were taken to assess superficial facial microbiota using 16S rRNA gene sequencing at the baseline and after 6 weeks: 1. Interglabellar 2. Nasolabial fold 3 |
| Overall study start date | 01/02/2017 |
| Completion date | 01/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 75 |
| Key inclusion criteria | 1. Aged 20 years or older 2. Clinical diagnosis of moderate or severe seborrheic dermatitis 3. Written informed consent |
| Key exclusion criteria | 1. HIV positive 2. Specific oral or topical treatments for seborrheic dermatitis (SD) in the previous 4 weeks 3. Pregnancy or breastfeeding 4. Known allergies to one or more component of the tested cream 5. Other inflammatory skin conditions other than SD 6. Use of oral probiotics in the previous 6 weeks 7. Cigarette smoking |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 01/12/2017 |
Locations
Countries of recruitment
- Italy
Study participating centres
Rome
00133
Italy
Via Conca
71
Ancona
60030
Italy
Modena
41122
Italy
Sponsor information
Industry
Via Milano 160
Caronno Pertusella
21042
Italy
| Phone | +39029659031 |
|---|---|
| massimo.milani@difacooper.com | |
"ROR" |
https://ror.org/044sr7e96 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish the study results on an international peer-reviewed indexed scientific journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Massimo Milani (massimo.milani@difacooper.com). Raw data are stored in an Excel datasheet and will be stored for 10 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 02/11/2018 | 23/11/2018 | No | No | |
| Results article | 02/05/2019 | 30/12/2022 | Yes | No |
Additional files
- ISRCTN74021432_BasicResults_02Nov2018.pdf
- Uploaded 23/11/2018
Editorial Notes
30/12/2022: Publication reference and total final enrolment added.
24/04/2019: Internal review.
23/11/2018: The basic results of this trial have been uploaded as an additional file.
