Condition category
Skin and Connective Tissue Diseases
Date applied
30/10/2018
Date assigned
08/11/2018
Last edited
23/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Editorial Notes

23/11/2018: The basic results of this trial have been uploaded as an additional file.