Condition category
Skin and Connective Tissue Diseases
Date applied
14/10/2015
Date assigned
16/10/2015
Last edited
15/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Eczema, also known as dermatitis, is a long-term medical condition which causes the skin to become dry, itchy and irritated. Atopic eczema (AE) is the most common type of eczema, particularly in children. It can appear anywhere on the body, but it is usually found on the face, trunk (chest and back) and around the inside of the elbows or knees. This type of eczema is called “atopic” because sufferers are more sensitive to allergens (substances which can cause an allergic reaction). The exact cause of AE is not fully understood, however it is thought that their skin does not produce as many protective oils as it should do and so the skin loses water easily. This means that the protective barrier of the skin is not as good as it should be, and so is more vulnerable to skin infections. Staphylococcus aureus is a common bacterium which lives on the skin. In people with AE, these bacteria are able to get into the skin, triggering an immune response causing “flare-ups” of symptoms. Many eczema treatments work by moisturising the skin with creams (emollients), which help to restore the skin barrier. The aim of this study is to look at the effectiveness of a new hydrating emollient cream containing a protein called isoleucine, which stimulates the skin to produce antimicrobial peptides (proteins which fight microorganisms like bacteria).

Who can participate?
Children with mild to moderate atopic eczema.

What does the study involve?
Participants are given two skin creams to apply twice a day for 8 weeks. The first cream is specially designed to be applied to the face and the second cream is specially designed for the body. At the start of the study and then after 4 and 8 weeks of using the creams, the children are examined to find out whether their eczema has improved. They are also interviewed to find out how itchy their eczema is. At the start of the study and again after 8 weeks of using the creams, the skin in the affected areas is swabbed so that the amount of Staphylococcus aureus can be measured.

What are the possible benefits and risks of participating?
Potential benefits of participating are that the creams may help to improve the symptoms of AE. There are no risks of participating in the study.

Where is the study run from?
Pediatric Clinic, University of Pavia (Italy)

When is the study starting and how long is it expected to run for?
January 2015 to September 2015

Who is funding the study?
Isdin (Italy)

Who is the main contact?
Dr Massimo Milani

Trial website

Contact information

Type

Public

Primary contact

Dr Massimo Milani

ORCID ID

http://orcid.org/0000-0001-7559-1202

Contact details

Viale Abruzzi 3
Milan
20126
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Nutra-01-2015

Study information

Scientific title

Barrier Repair Therapy in Atopic Eczema: effects of isoleucine, rhamnosoft and niacinamide facial and body creams on clinical, itch and Staphylococcus aureus skin colonization: A prospective assessor-blinbed study

Acronym

Study hypothesis

To evaluate the clinical effects (signs of inflammation and the anti-itch effects) and Staphylococcus aureus colonization of two creams (one specifically formulated for application on face and the other formulated for the body) containing emollient, hydrating and and a Anti microbial Peptides promoting agent (Iso-leucine) in children with mid to moderate atopic eczema.

Ethics approval

IRB Pavia Hospital, 18/12/2014

Study design

Prospective assessor-blinded single-arm multi-centre study

Primary study design

Interventional

Secondary study design

Single-arm prospective assessor blinded trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Atopic Eczema

Intervention

Participants are provided with two products concurrently to apply twice daily for 8 consecutive weeks:

1. Participants apply 2 Finger Tip Units (1g) of the Nutratopic pro-AMP facial cream containing rhamnosoft, niacinamede and isoleucine to the face
2. Participants apply 5 Finger Tip Units of the Nutratopic pro-AMP body cream containing rhamnosoft, niacinamede and isoleucine the the body (upper, lower arms and trunk).

At baseline, week 4 and week 8, eczema severity, scoring redness, thickness scratching and lichenification are assessed. Skin swabs are taken for detection of S. aureus were obtained from lesional skin at baseline and at month 2.

Intervention type

Drug

Phase

Phase IV

Drug names

1. Nutratopic pro-AMP facial cream
2. Nutratopic pro-AMP body cream

Primary outcome measures

1. Eczema severity is measured using the Eczema Severity Index score (4-point scale) at baseline, week 4 and week 8
2. Itch intensity evaluated by a 10-cm Visual Analogue Scale at baseline, week 4 and week 8

Secondary outcome measures

Staphylococcus aureus skin colonization is obtained from lesions using skin swabs at baseline and 2 months.

Overall trial start date

01/01/2015

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 2 and 18 years
2. Mild to moderate atopic eczema according to Hanifin diagnostic criteria

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

45

Participant exclusion criteria

1. Severe form of atopic eczema
2. Use of corticosteroids, calcineurin inhibitors or systemic or topical antibiotics in the 4 weeks prior to enrollement

Recruitment start date

02/01/2015

Recruitment end date

30/06/2015

Locations

Countries of recruitment

Italy

Trial participating centre

Pediatric Clinic, University of Pavia
IRCCS Policlinico "S. Matteo" Foundation
Pavia
20125
Italy

Sponsor information

Organisation

Isdin

Sponsor details

Viale Abruzzi 3
Milan
20123
Italy

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Isdin

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in an indexed international scientific journal (Pediatric Allergy and Immunology).

Intention to publish date

31/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes