Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01142999
Protocol/serial number
UK: 09DE005; USA: 6083
Study information
Scientific title
Feasibility study of Barrier Enhancement for Eczema Prevention: a multicentre, assessor-blinded, randomised controlled trial
Acronym
The BEEP Study
Study hypothesis
Enhancing the skin barrier from birth with emollients will prevent or delay the onset of eczema in high risk infants.
Ethics approval
1. UK: Nottingham Research Ethics Committee 1, 13/11/2009, ref: 09/H0407/43
2. USA: OHSU Research Integrity Office
Study design
Multicentre assessor-blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Can be found at http://www.beepstudy.org
Condition
Prevention of eczema
Intervention
UK site:
The intervention group will apply emollient to the infants entire skin surface once a day (except the scalp which is optional) especially after bathing. Parents will choose from three emollients that vary in texture and viscosity:
1. Sunflower seed oil
2. Doublebase
3. 50:50 white soft paraffin/liquid paraffin
The control group will not apply emollients
USA site:
The intervention group will apply emollient to the infants entire skin surface once a day (except the scalp which is optional) especially after bathing. Parents will choose from three emollients that vary in texture and viscosity:
1. Sunflower oil
2. Cetaphil cream
3. Aquaphor ointment
The control group will not apply emollients
Both sites:
The intervention will commence within 3 weeks of the birth. Both the intervention and control groups will receive best practice instructions on bathing and cleansing of their infant which will be standardised to minimise investigator counselling and inter-investigator variability:
1. Avoid the use of soap and bubble bath
2. Use only a mild cleanser and shampoo
3. The use of baby wipes will be discouraged
Total duration of treatment and follow up is 6 months for all arms.
As of 21/03/2012, the record has been updated to include the following:
The study has been extended to follow up the participants until their 2nd birthday. The 6 month intervention period remains unchanged.
Sponsor details for the USA site:
National Eczema Association (USA)
4460 Redwood Highway, Suite 16-D
San Rafael, California
94903-1953
United States of America
Website: http://www.nationaleczema.org
Contact details for the USA site :
Dr Eric Simpson
Oregon Health & Science University
Department of Dermatology (CH16D)
3303 S.W. Bond Avenue
Portland, Oregon
97239-4501
United States of America
Intervention type
Drug
Phase
Not Applicable
Drug names
Sunflower seed oil, Doublebase, white soft paraffin, liquid paraffin
Primary outcome measure
Proportion of families willing to be randomised. This is the most critical component of the success of any future trial.
Secondary outcome measures
1. Proportion of families eligible for the trial
2. Proportion of families accepting the initial invitation to participate
3. Proportion of families who found the interventions acceptable
4. Reported adherence with intervention
5. Proportion of families for whom the blinding of the assessor to the allocation status was not compromised
6. Amount of contamination as a result of increased awareness in the control group
7. Percentage of missing data and early withdrawal rates
8. Incidence of emollient-related adverse events
9. Incidence of eczema at 6 months
10. Age at onset of eczema and the proportion which are transient cases
11. Filaggrin mutation status
Overall trial start date
01/02/2010
Overall trial end date
01/02/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
UK and USA:
1. Infants with a family history of eczema, asthma or allergic rhinitis
2. Infant in overall good health
3. Mother aged between 16 and 45 years at delivery and capable of giving informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
200 infants to be enrolled
Participant exclusion criteria
UK and USA:
1. Preterm birth (defined as birth prior to 37 weeks gestation)
2. Major congenital anomaly
3. Hydrops fetalis
4. Significant dermatitis at birth not including seborrheic dermatitis (cradle cap) (added 13/07/2010)
5. Any severe genetic skin disorder or immunodeficiency
6. Any other serious condition that would make the use of emollients inadvisable
7. Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess
8. Taken supplements containing Lactobacillus Rhamnosus during pregnancy or plan to take whilst lactating (added 13/07/2010)
Recruitment start date
01/02/2010
Recruitment end date
01/02/2013
Locations
Countries of recruitment
United Kingdom, United States of America
Trial participating centre
Centre of Evidence Based Dermatology
Nottingham
NG7 2NR
United Kingdom
Sponsor information
Organisation
Nottingham University Hospitals NHS Trust (UK)
Sponsor details
Research & Development Department
E11
Curie Court
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Programme Grants for Applied Research (PGfAR) (ref: RP-PG-0407-1017)
Alternative name(s)
NIHR Programme Grants for Applied Research, PGfAR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
National Eczema Association (USA) (added 13/07/2010)
Alternative name(s)
The National Eczema Association, NEA
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25282563
Publication citations
-
Results
Simpson EL, Chalmers JR, Hanifin JM, Thomas KS, Cork MJ, McLean WH, Brown SJ, Chen Z, Chen Y, Williams HC, Emollient enhancement of the skin barrier from birth offers effective atopic dermatitis prevention., J. Allergy Clin. Immunol., 2014, 134, 4, 818-823, doi: 10.1016/j.jaci.2014.08.005.