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

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Joanne Chalmers


Contact details

Centre of Evidence Based Dermatology
Kings Meadow Campus
University of Nottingham
Lenton Lane
United Kingdom

Additional identifiers

EudraCT number number


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


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.

Please note that as of 13/07/2010 this record was updated to include more information on the USA study site and a few protocol amendments to the UK site information. All additions can be found in the relevant section with the subtitle: ‘USA site’, or with the above update date.

At this time, the target number of participants for the study was amended to read 200 patients to be enrolled in total (previously 50). This takes into account how many it is anticipated will be needed to be enrolled in each country (100) to reach a randomised number of 50 in each country.

Please also note that the study dates for each site are as follows:
UK anticipated trial dates:
Start date: 01/02/2010
End date: 01/02/2011

USA anticipated trial dates:
Start date: 04/08/2010
End date: 04/07/2011

As of 21/03/2012, the anticipated end date of trial has been updated from 04/07/2011 to 01/02/2013.

Ethics approval

1. UK: Nottingham Research Ethics Committee 1 approved on the 13th November 2009 (ref: 09/H0407/43)
2. USA: OHSU Research Integrity Office

Study design

Multicentre assessor-blinded randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Can be found at


Prevention of eczema


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
United States of America

Contact details for the USA site :
Dr Eric Simpson
Oregon Health & Science University
Department of Dermatology (CH16D)
3303 S.W. Bond Avenue
Portland, Oregon
United States of America

Intervention type



Not Applicable

Drug names

Sunflower seed oil, Doublebase, white soft paraffin, liquid paraffin

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom, United States of America

Trial participating centre

Centre of Evidence Based Dermatology
United Kingdom

Sponsor information


Nottingham University Hospitals NHS Trust (UK)

Sponsor details

Research & Development Department
Curie Court
Queen’s Medical Centre
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0407-1017)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

National Eczema Association (USA) (added 13/07/2010)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype



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

Results - basic reporting

Publication summary

2014 Results in

Publication citations

  1. 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.

Additional files

Editorial Notes