Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Massimo Milani
ORCID ID
http://orcid.org/0000-0001-7559-1202
Contact details
Via Milano 160
Caronno Pertusella
21042
Italy
+39029659031
massimo.milani@difacooper.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EutrosisDs02/2017
Study information
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
Acronym
Study hypothesis
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
Institutional Review Board of the Coordinating Center (Tor Vergata University, Rome), 22/02/2017, 18bis/2017
Study design
Interventional prospective multi-center open assessor-blinded non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
01/02/2017
Overall trial end date
01/05/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 20 years or older
2. Clinical diagnosis of moderate or severe seborrheic dermatitis
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant 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
Recruitment start date
01/04/2017
Recruitment end date
01/12/2017
Locations
Countries of recruitment
Italy
Trial participating centre
Dermatology Clinic University Tor Vergata
POLICLINICO TOR VERGATA Viale Oxford, 81 - 00133 Roma
Rome
00133
Italy
Trial participating centre
Dermatology Clinic University of Ancona
Le Torrette Hospital
Via Conca
71
Ancona
60030
Italy
Trial participating centre
Poliambulatorio Medica Plus
Viale dei Caduti in Guerra 101
Modena
41122
Italy
Sponsor information
Organisation
Difa Cooper
Sponsor details
Via Milano 160
Caronno Pertusella
21042
Italy
+39029659031
massimo.milani@difacooper.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Difa Cooper
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to publish the study results on an international peer-reviewed indexed scientific journal
IPD sharing statement:
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.
Intention to publish date
01/01/2019
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN74021432_BasicResults_02Nov2018.pdf
Publication list
Publication citations
Additional files
- ISRCTN74021432_BasicResults_02Nov2018.pdf Uploaded 23/11/2018