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
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