Feasibility study of Barrier Enhancement for Eczema Prevention

ISRCTN ISRCTN84854178
DOI https://doi.org/10.1186/ISRCTN84854178
ClinicalTrials.gov number NCT01142999
Secondary identifying numbers UK: 09DE005; USA: 6083
Submission date
08/01/2010
Registration date
26/02/2010
Last edited
04/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Joanne Chalmers
Scientific

Centre of Evidence Based Dermatology
Kings Meadow Campus
University of Nottingham
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Study information

Study designMulticentre assessor-blinded randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typePrevention
Participant information sheet Can be found at http://www.beepstudy.org
Scientific titleFeasibility study of Barrier Enhancement for Eczema Prevention: a multicentre, assessor-blinded, randomised controlled trial
Study acronymThe BEEP Study
Study objectivesEnhancing the skin barrier from birth with emollients will prevent or delay the onset of eczema in high risk infants.
Ethics approval(s)1. UK: Nottingham Research Ethics Committee 1, 13/11/2009, ref: 09/H0407/43
2. USA: OHSU Research Integrity Office
Health condition(s) or problem(s) studiedPrevention of eczema
InterventionUK 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Sunflower seed oil, Doublebase, white soft paraffin, liquid paraffin
Primary outcome measureProportion of families willing to be randomised. This is the most critical component of the success of any future trial.
Secondary outcome measures1. 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 study start date01/02/2010
Completion date01/02/2013

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants200 infants to be enrolled
Key inclusion criteriaUK 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
Key exclusion criteriaUK 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)
Date of first enrolment01/02/2010
Date of final enrolment01/02/2013

Locations

Countries of recruitment

  • England
  • United Kingdom
  • United States of America

Study participating centre

Centre of Evidence Based Dermatology
Nottingham
NG7 2NR
United Kingdom

Sponsor information

Nottingham University Hospitals NHS Trust (UK)
Hospital/treatment centre

Research & Development Department
E11, Curie Court
Queen’s Medical Centre
Nottingham
NG7 2UH
England
United Kingdom

Website http://www.nuh.nhs.uk/
ROR logo "ROR" https://ror.org/05y3qh794

Funders

Funder type

Government

Programme Grants for Applied Research (PGfAR) (ref: RP-PG-0407-1017)
Government organisation / National government
Alternative name(s)
NIHR Programme Grants for Applied Research, PGfAR
Location
United Kingdom
National Eczema Association (USA) (added 13/07/2010)
Government organisation / Associations and societies (private and public)
Alternative name(s)
National Eczema Assoc., NEA
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2014 Yes No

Editorial Notes

04/01/2019: Internal review.

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.