Condition category
Skin and Connective Tissue Diseases
Date applied
16/10/2019
Date assigned
17/10/2019
Last edited
11/11/2019
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 condition that causes redness of the skin, flaking/scaling and dandruff. It is thought that excess oil production in the skin and overgrowth of Malassezia furfur (a type of yeast fungus that is normally found on the skin) can contribute to SD. Nutradeica is a cream that contains agents that reduce fungal growth, oil production and inflammation. This study aims to investigate whether Nutradeica can treat SD.

Who can participate?
Men aged 21-65 years who have SD on their face and chest, but otherwise are in good health.

What does the study involve?
All participants will apply the cream to their face and chest twice daily for 14 days. Before the start of treatment, at 7 days after the start of treatment and at 14 days after the start of treatment, they will have skin scrapings and small skin samples taken, fill in some forms to assess their SD symptoms and be assessed by the researchers.

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 microbial skin flora may be re-balanced. The possible risks related to the skin sample procedure are represented, in the worst cases, by a spot about 2 mm of slightly different complexion (lighter or darker) than the surrounding skin or a small scar of 2 mm, similar to a chicken pox scar

Where is the study run from?
Dermatology Unit of University of Naples Federico II (Italy)

When is the study starting and how long is it expected to run for?
May 2017 to April 2019

Who is funding the study?
ISDIN, the company that makes Nutradeica

Who is the main contact?
Javier Bustos, javier.bustos@isdin.com

Trial website

Contact information

Type

Public

Primary contact

Mr Javier Bustos

ORCID ID

Contact details

ISDIN S.A.
Provençals 33
Barcelona
08019
Spain
+34 (0)932402020
javier.bustos@isdin.com

Additional identifiers

EudraCT number

2019-003813-32

ClinicalTrials.gov number

Nil known

Protocol/serial number

ISD-CL-DE-1058-01-2017

Study information

Scientific title

Experimental, prospective, open, monocenter, clinical trial for the evaluation of a novel cream used to improve the condition of seborrheic dermatitis topically applied on face and chest in patients with seborrheic dermatitis

Acronym

Study hypothesis

The pathogenesis of seborrheic dermatitis (SD) is multifactorial and traditional treatments may not target all aspects of them.The aim of this study was to evaluate short term anti-fungal, anti-microbial, anti-inflammatory and anti-pruritus properties of a novel non-steroidal cream (NSC) containing piroctone olamine, zinc PCA, hydroxyphenyl propamidobenzoic acid, biosaccharide gum-2 and stearyl glycyrrhetinate in patients with face and chest SD.

Ethics approval

Approved 19/03/2018, Ethics Committee for Biomedical Activities “Carlo Romano” of University of Naples Federico II (Dipartimento di Scienze Biomediche Avanzate, Via S. Pansini, 5-80131 Napoli, Italy; +39 (081)7463468 e-mail: comitato.etico@unina.it), ref: 35/18

Study design

Single-centre prospective open-label trial

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 the contact details below to request a participant information sheet.

Condition

Seborrheic dermatitis

Intervention

Patients were instructed to apply Nutradeica cream twice daily on the face and on the chest for 14 days. The investigator evaluated their skin condition at first visit and after 7 and 14 days of product use. A physican will perform skin scale scraping from the face (wings of the nose) and the chest through the study. In addition, the physician will perfom a biopsy (2 mm diameter) in the same area on the chest at first visit and after 7 days product use.

Intervention type

Drug

Phase

Not Specified

Drug names

Nutradeica (containing active agents piroctone olamine , zinc PCA, hydroxyphenyl propamidobenzoic acid, biosaccharide gum-2 and stearyl glycyrrhetinate)

Primary outcome measure

1. Severity of seborrheic dermatitis assessed using a scoring index (SI) evaluating erythema, desquamation, itching and irritation at baseline and after 7 and 14 days of treatment
2. Seborrheic dermatitis severity assessed using the Investigator's Global Assessment Score (IGA) at baseline and after 7 and 14 days of treatment

Secondary outcome measures

1. Patient evaluation of erythema assessed using a visual analog scale at baseline and after 7 and 14 days of treatment
2. Patient evaluation of scaling assessed using a visual analog scale at baseline and after 7 and 14 days of treatment
3. Patient evaluation of itching assessed using a visual analog scale at baseline and after 7 and 14 days of treatment
4. Patient evaluation of sensation of heat assessed using a visual analog scale at baseline and after 7 and 14 days of treatment
5. Patient evaluation of pain assessed using a visual analog scale at at baseline and after 7 and 14 days of treatment
6. Patient evaluation of irritation assessed using a visual analog scale at baseline and after 7 and 14 days of treatment
7. Patient evaluation of seborrheic dermatitis severity change assessed using the Patient Global Assessment (PGA) after 7 and 14 days of treatment
8. Antifungal effect assessed by quantifying Malassezia furfur colony-forming units from skin scrapings at baseline and after 7 and 14 days of treatment
9. Antimicrobial effect assessed by quantifying Staphylococcus epidermidis colony-forming units from skin scrapings and gene expression of antimicrobial peptides (HBD2 and HBD3) at baseline and after 7 and 14 days of treatment
10. Anti-inflammatory effect assessed by quantifying gene expression of IL-1α, IL-1β, IL-6, IL-8 and TNF-α in skin biopsies at baseline and after 7 and 14 days of treatment
11. Anti-pruritic effect assessed by quantifying gene expression of cathepsin S (CTS) and L-histidine decarboxylase (HDC) in skin biopsies at baseline and after 7 and 14 days of treatment
12. Tolerability assessed by quantifying adverse events recorded by the investigator or reported by patients during the study

Overall trial start date

01/05/2017

Overall trial end date

01/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Males in otherwise good health
2. Aged 21-65 years at time of enrollment
3. Mild to moderate visible SD on face and chest area

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

12

Total final enrolment

12

Participant exclusion criteria

1. Acute or chronic disease or medical condition that could put participant at risk in the opinion of the Principal Investigator or compromise study outcomes
2. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
3. Immunocompromised
4. Taking other medications (oral or topical) that could interfere with the interpretation of the results

Recruitment start date

11/04/2018

Recruitment end date

22/02/2019

Locations

Countries of recruitment

Italy

Trial participating centre

Dermatology Unit of University of Naples Federico II
Universita Di Napoli Federico II Azienda Ospedaliera Universitaria Federico II Dip. Ad Attivita Integrata di Medicina Clinica Via S. Pansini, 5
Naples
80131
Italy

Sponsor information

Organisation

ISDIN S.A.

Sponsor details

Provençals 33
Barcelona
08019
Spain
+34 (0)932402020
javier.bustos@isdin.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

ISDIN S.A.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers intend to publish the study results in an international peer-reviewed indexed scientific journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Written informed consent from participants was obtained.

Intention to publish date

01/11/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31705438 (added 11/11/2019)

Publication citations

Additional files

Editorial Notes

11/11/2019: Publication reference, total final enrolment number and EudraCT number added. 17/10/2019: Trial's existence confirmed by the University of Naples Federico II Ethics Committee.