Condition category
Skin and Connective Tissue Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
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



Primary contact

Dr Massimo Milani


Contact details

Viale Abruzzi 3

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Single-arm prospective assessor blinded trial

Trial setting


Trial type


Patient information sheet


Atopic Eczema


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



Phase IV

Drug names

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

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

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

Sponsor information



Sponsor details

Viale Abruzzi 3

Sponsor type




Funder type


Funder name


Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

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

Intention to publish date


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes