Emollient creams for face and body improve eczema in children with atopic dermatitis and help to restablish the normal skin flora
| ISRCTN | ISRCTN24922464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24922464 |
| Secondary identifying numbers | Nutra-01-2015 |
- Submission date
- 14/10/2015
- Registration date
- 16/10/2015
- Last edited
- 13/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Public
Viale Abruzzi 3
Milan
20126
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|
Study information
| Study design | Prospective assessor-blinded single-arm multi-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-arm prospective assessor blinded trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 objectives | 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(s) | IRB Pavia Hospital, 18/12/2014 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2015 |
| Completion date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 45 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1. Aged between 2 and 18 years 2. Mild to moderate atopic eczema according to Hanifin diagnostic criteria |
| Key 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 |
| Date of first enrolment | 02/01/2015 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- Italy
Study participating centre
Pavia
20125
Italy
Sponsor information
Industry
Viale Abruzzi 3
Milan
20123
Italy
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in an indexed international scientific journal (Pediatric Allergy and Immunology). |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/01/2016 | 13/05/2021 | Yes | No |
Editorial Notes
13/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
