The PEBBLES study: Prevention of Eczema By a Barrier Lipid Equilibrium Strategy

Phase 2

Completed

• Conditions: eczema; Skin - Dermatological conditions

• Registration Number: ACTRN12613000472774
• Lead Sponsor: Murdoch Childrens Research Institute

Brief Summary

In this pilot study (80 infants), we assessed if the application of a specific cream (EpiCeram™) to the skin of new-born infant’s twice-daily for six months, would help build up skin barrier function and reduce the risk that these children would develop eczema and allergic sensitisation to foods. Our results revealed a trend towards a reduced risk of eczema and food sensitisation in infants from the ‘cream’ group at 12 months of age, particularly if it was used from within the first two weeks of life, and applied regularly. This was the first time that possible beneficial effects of this type of treatment beyond the treatment period have been demonstrated

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-26
• Study Completion: 2015-06-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Either mother and/or father has a self reported history of:
- asthma and/or
- eczema/atopic dermatitis and/or
- hayfever/allergic rhinitis and/or
- food allergy

Exclusion Criteria

- A parent who has a known hypersensitivity to any of the ingredients of EpiCeram.
- Multiple births (twins, triplets etc.)
- Premature infants (<36 weeks)
- Infants with major birth or early life medical complications that require admission into a special care nursery.
- Infants whose parents are not able to comply with all protocol required visits and procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of eczema as assessed using the UK working party criteria for eczema[6 weeks and 6 months post randomisation];Transepidermal water loss (TEWL) as assessed using Vapometer on the infants forearm and forehead [6 weeks and 6 months post randomisation]

Secondary Outcome Measures

Name	Time	Method
Presence of eczema, as assessed using the UK working party criteria for eczema, six months post cessation of study treatment[12 months post randomisation];Probable eczema, as defined by diagnosis of eczema by medical practitioner that was not verified by the study investigators.[During treatment period (0 to 6 months), and for six months (7 to 12 months of age) post cessation of treatment ];Eczema severity as measured by SCORing Atopic Dermatitis (SCORAD)[6 weeks, 6 months & 12 months of age];Skin prick test reactivity to six common food (cows' milk, peanut and hens egg) and areo-allergens (house dust mite, rye grass and cat dander), defined as a wheal of 3mm or greater than the negative saline control.[6 and 12 months post randomisation];Biomechanical properties of the skin (pH, hydration, oiliness) assessed using a Skin-pH-Meter (PH905), Coneometer (CM 825), and Sebumeter (SM 815) from Courage + Khazaka electronic[6 weeks, 6 and 12 months post randomisation]