A randomized trial of a barrier lipid replacement strategy for the prevention of atopic dermatitis and allergic sensitization: the PEBBLES pilot study
Abstract
Dear Editor, It is hypothesized that the impaired skin barrier in atopic dermatitis (AD) allows the immune system to be exposed to environmental allergens, resulting in sensitization and allergic disease.1 Two small trials recently found that routine use of emollients reduced the incidence of AD during the active treatment period by approximately half.2,3 It remains unknown whether prophylactic use of emollients can prevent the development of AD beyond the treatment period (as opposed simply to delaying its onset) or whether this reduction in AD leads to a reduced risk of allergic sensitization. The previous trials in this area have used standard emollients.2,3 In this trial, we chose a ceramide‐dominant emollient (EpiCeram™; PuraCap Pharmaceutical LLC, South Plainfield, NJ, U.S.A.), as it may provide greater preventive effects.4 Skin affected by AD is deficient in ceramides.5 EpiCeram has been formulated to contain physiological ratios of ceramides, cholesterol and free fatty acids, and has a slightly acidic pH (5·0), which aids the production and secretion of ceramides by the skin.6 Acidic emollients have been shown to help prevent AD and airway inflammation in a murine model.7 We have previously demonstrated parent compliance, and initial evidence of safety, for use of EpiCeram for AD prevention in neonates.8 We conducted a pilot randomized, parallel, single‐blind (outcome assessor), controlled trial of the effect of twice‐daily application of EpiCeram for the first 6 months of life on the incidence of AD and skin barrier function in high‐risk infants up to 12 months of age. Term infants with a family history of allergic disease were recruited from maternity wards (Appendix S1; see Supporting Information). At enrolment, parents of infants in the intervention group were shown how to apply approximately 6 g of EpiCeram to the full skin surface of their child twice per day. Treatment was to commence within the first 3 weeks. No other skincare instructions were provided to either group. Clinical follow‐up of infants by a blinded assessor (C.A.) occurred at 6 weeks, 6 months and 12 months of age. Transepidermal water loss (TEWL), skin pH, hydration and ‘oiliness' (sebum) were assessed using standardized protocols (Courage & Khazaka, Cologne, Germany). At 6 and 12 months, skin prick tests were performed to six common allergens along with saline and histamine controls (Stallergenes lancets: Stallergenes, Antony, France; HollisterStier aero‐allergen extracts: HollisterStier, Spokane, WA, U.S.A.; ALK food allergen extracts: ALK, Inc., Round Rock, TX, U.S.A.). A total of 1306 infants were screened and 80 were recruited. The groups were well balanced on a range of baseline factors. There was minimal loss to follow‐up at each time point (Appendix S1). There were no adverse reactions to the study cream. Adherence to the intervention was high (76% applied the cream for ≥ 5 days per week). Use of other emollients (not study treatment) for on average ≥ 3 days per week during the intervention period occurred in 39% of the control group and 18% of the intervention group. Intention‐to‐treat analysis showed no significant effect of routine barrier lipid replacement in early life on AD or sensitization outcomes. However, there was a trend towards reduced risks of AD and food sensitization in the intervention group at 6 and 12 months of age (Table 1 and Appendix S1). Adjustment for slight baseline imbalances between groups (presence of siblings, forehead TEWL) did not materially alter the results (data not shown). Per protocol analyses (only including infants who received ≥ 5 days per week of study treatment) revealed a significant reduction in food sensitization at 12 months in the treatment group (0%, 0 of 21 vs. 19%, seven of 36, P = 0·04). There were no differences between groups for biophysical properties of the skin. Among the intervention group, children who developed food sensitization had a later initiation of treatment (Appendix S1). Effect of intervention on atopic dermatitis (AD) at 6 weeks, 6 months and 12 months CI, confidence interval. aEstimated using Fisher's exact test. bCombines responses from prior clinical assessments. cFood allergens: egg white, cow's milk and peanut. dInhalant allergens: dust mite, cat dander and rye grass. Effect of intervention on atopic dermatitis (AD) at 6 weeks, 6 months and 12 months CI, confidence interval. aEstimated using Fisher's exact test. bCombines responses from prior clinical assessments. cFood allergens: egg white, cow's milk and peanut. dInhalant allergens: dust mite, cat dander and rye grass. We found that twice‐daily prophylactic use of a ceramide‐dominant emollient, from the neonatal period to 6 months of age, was associated with a trend towards reduced incidence of AD and food sensitization at age 12 months, suggesting that the beneficial effects persisted for ≥ 6 months after stopping treatment. While these results require confirmation, they support a role for skin
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Maintaining normal skin barrier function is critical for the prevention and control of allergic diseases such as AD and food allergy.
“It has been suggested that maintaining normal skin barrier function is critical for the prevention and control of allergic diseases such as AD and food allergy (14, 16, 60–62).”
From Particulate matter causes skin barrier dysfunction. (2021) · cites this paper as [62]
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Sindher, S., Alkotob, S., Shojinaga, M. N., Hamilton, R. G., Chan, S., Cao, S., Bahnson, H. T., Brough, H. A., Lack, G., Leung, D. Y. M., et al. (2020) · Pediatric Allergy and Immunology · doi:10.1111/pai.13253 · Cited by 20 · see citing works
Liang, J., Hu, F., Tang, H., Jiang, F.-H., Sang, Y., Hong, Y., Wang, Q., Nuer, K., & Kang, X. (2022) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/jdv.18688 · Cited by 25 · see citing works
Clinical Manifestations of Pediatric Food Allergy: a Contemporary Review
Wang, L., Mu, S., Lin, M.-I., Sung, T.-C., Chiang, B., & Lin, C.-H. (2021) · Clinical Reviews in Allergy & Immunology · doi:10.1007/s12016-021-08895-w · Cited by 20 · see citing works
Topical emollient prevents the development of atopic dermatitis and atopic march in mice
Zhang, J., Xu, X., Wang, X., Zhang, L., Hu, M., Le, Y., Chen, L., & Zheng, J. (2023) · Experimental Dermatology · doi:10.1111/exd.14806 · Cited by 19 · see citing works
Management of Infant Atopic Eczema to Prevent Severe Eczema and Food Allergy
Yamamoto‐Hanada, K., & Ohya, Y. (2024) · Clinical & Experimental Allergy · doi:10.1111/cea.14515 · Cited by 20 · see citing works
Gelmetti, C. M., Rigoni, C., Cantù, A., The members of the Italian Group (in alphabetical order):, Agolzer, A., Agrusa, A., Brena, M., Dall’Oglio, F., DEMICHELIS, P., Farina, S., et al. (2022) · Journal of Dermatological Treatment · doi:10.1080/09546634.2022.2131703 · Cited by 17 · see citing works
Advances and potential of omics studies for understanding the development of food allergy
Sindher, S., Chin, A. R., Aghaeepour, N., Prince, L. S., Maecker, H. T., Shaw, G. M., Stevenson, D. K., Nadeau, K. C., Snyder, M. P., Khatri, P., et al. (2023) · Frontiers in Allergy · doi:10.3389/falgy.2023.1149008 · Cited by 15 · see citing works
Grześk-Kaczyńska, M., Petrus-Halicka, J., Kaczyński, S., Bartuzi, Z., & Ukleja-Sokołowska, N. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13030863 · Cited by 16 · see citing works
Moncrieff, G., Lied‐Lied, A., Nelson, G., Holy, C. E., Weinstein, R. B., Wei, D., & Rowe, S. (2018) · BMC Dermatology · doi:10.1186/s12895-018-0076-y · Cited by 16 · see citing works
Advances in the approach to the patient with food allergy
Scurlock, A. M., & Jones, S. M. (2018) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2017.12.1008 · Cited by 16 · see citing works
Herman, K. E., Brough, H. A., Pier, J., Venter, C., & Järvinen, K. M. (2024) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2024.04.029 · Cited by 17 · see citing works
Inuzuka, Y., Yamamoto‐Hanada, K., Kobayashi, T., Pak, K., Toyokuni, K., Ogita, H., Miyoshi, T., Ogawa, K., Sago, H., & Ohya, Y. (2023) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/jdv.19375 · Cited by 14 · see citing works
Current Controversies and Future Prospects for Peanut Allergy Prevention, Diagnosis and Therapies
Gray, C. L. (2020) · Journal of Asthma and Allergy · doi:10.2147/jaa.s196268 · Cited by 14 · see citing works
Skin‐centered strategies in food allergy prevention
Braun, C., Coutier, L., Bégin, P., & Nosbaum, A. (2024) · Pediatric Allergy and Immunology · doi:10.1111/pai.14130 · Cited by 14 · see citing works
Soriano, V. X., Allen, K. J., Dharmage, S. C., Shifti, D. M., Perrett, K. P., Wijesuriya, R., Koplin, J. J., & Peters, R. L. (2024) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2024.07.001 · Cited by 13 · see citing works
Self-citationThe ins and outs of an ‘outside-in’ view of allergies: atopic dermatitis and allergy prevention
Shaker, M. S., Murray, R. G. P., & Mann, J. A. (2018) · Current Opinion in Pediatrics · doi:10.1097/mop.0000000000000646 · Cited by 13 · see citing works
Schachner, L. A., Andriessen, A., Benjamin, L., Bree, A. F., Lechman, P., Pinera-Llano, A., & Kircik, L. (2020) · Journal of Drugs in Dermatology · doi:10.36849/jdd.2020.5252 · Cited by 12 · see citing works
Kottner, J., Hillmann, K., Fastner, A., Conzade, R., Heidingsfelder, S., Neumann, K., Blume‐Peytavi, U., & ADAPI Study Group (2022) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/jdv.18698 · Cited by 11 · see citing works
Food allergy prevention: current evidence
Baker, M. G., & Nowak-Wegrzyn, A. H. (2020) · Current Opinion in Clinical Nutrition & Metabolic Care · doi:10.1097/mco.0000000000000651 · Cited by 12 · see citing works
The role of the skin in the atopic march
Tang, X., & Li, M. (2024) · International Immunology · doi:10.1093/intimm/dxae053 · Cited by 10 · see citing works
Fowler, J. F., Ma, L., Bergman, J. N., Horowitz, P., Lavender, T., Eichenfield, L. F., Draelos, Z. D., Danby, S. G., & Cork, M. J. (2025) · Journal of Dermatological Treatment · doi:10.1080/09546634.2025.2487945 · Cited by 11 · see citing works
Potential Strategies and Targets for the Prevention of Pediatric Asthma
Polk, B. I., & Bacharier, L. B. (2019) · Immunology and Allergy Clinics of North America · doi:10.1016/j.iac.2018.12.010 · Cited by 10 · see citing works
Topical emollient application in term healthy newborns: A systematic review
Priyadarshi, M., Balachander, B., Gupta, S., & Sankar, M. J. (2022) · Journal of Global Health · doi:10.7189/jogh.12.12002 · Cited by 10 · see citing works
Koplin, J. J., Peters, R. L., & Allen, K. J. (2017) · Immunology and Allergy Clinics of North America · doi:10.1016/j.iac.2017.09.001 · Cited by 10 · see citing works
Self-citationPrimary Prevention of Canine Atopic Dermatitis: Breaking the Cycle—A Narrative Review
Fernandes, B. A. P., Alves, S. P., Schmidt, V. M., Bizarro, A. F., Pinto, M. S. D. N., Pereira, H. M. L., Marto, J. M., & Lourenço, A. M. (2023) · Veterinary Sciences · doi:10.3390/vetsci10110659 · Cited by 9 · see citing works
Landau, T., Gamrasni, K., Levin, A., Barlev, Y., Sanders, O., Benor, S., & Brandwein, M. (2024) · Annals of Allergy Asthma & Immunology · doi:10.1016/j.anai.2024.06.010 · Cited by 8 · see citing works
Abrams, E. M., & Chan, E. S. (2019) · Immunology and Allergy Clinics of North America · doi:10.1016/j.iac.2019.06.001 · Cited by 8 · see citing works
SCHACHNER, L. A., Blume‐Peytavi, U., ANDRIESSEN, A., IZAKOVIC, J., Maruani, A., Micali, G., MURASHKIN, N., SALAVASTRU, C., & TORRELO, A. (2022) · Italian Journal of Dermatology and Venereology · doi:10.23736/s2784-8671.21.07172-3 · Cited by 8 · see citing works
Inuzuka, Y., Yamamoto‐Hanada, K., Pak, K., Miyoshi, T., Kobayashi, T., & Ohya, Y. (2022) · Frontiers in Allergy · doi:10.3389/falgy.2022.862620 · Cited by 8 · see citing works
Prévention primaire de l’allergie alimentaire du jeune enfant, actualités et propositions
Sabouraud-Leclerc, D., Bradatan, E., Moraly, T., Payot, F., Chabbert, A., Pontcharraud, R., Larue, C., Nemni, A., Juchet, A., Morisset, M., et al. (2022) · Revue française d'allergologie · doi:10.1016/j.reval.2022.01.002 · Cited by 7 · see citing works
Prevention of Non-peanut Food Allergies
Abrams, E. M., & Chan, E. S. (2019) · Current Allergy and Asthma Reports · doi:10.1007/s11882-019-0891-1 · Cited by 6 · see citing works
Yamamoto‐Hanada, K., Pak, K., Sato, M., Kram, Y. E., Takemura, Y., Inoue, N., & Ohya, Y. (2021) · Clinical & Experimental Allergy · doi:10.1111/cea.14035 · Cited by 6 · see citing works
- Authors
- Lowe, A. J., Su, J. C., Allen, K. J., Abramson, M. J., Cranswick, N., Robertson, C. F., Forster, D., Varigos, G., Hamilton, S., Kennedy, R., Axelrad, C., Tang, M. L. K., & Dharmage, S. C.
- Affiliations
- Royal Children's Hospital (AU)
- Monash University (AU)
- Royal Women's Hospital (AU)
- ORCID
- Venue
- British Journal of Dermatology
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-12
- Volume
- 178
- Issue
- 1
- Pages
- e19-e21
- ISSN
- 0007-0963 (ISSN-L)
- 1365-2133
- OpenAlex
- W2643531449
- Cited by
- 160
- References
- 8
- Citations by year
- 2026: 7 · 2025: 7 · 2024: 20 · 2023: 13 · 2022: 28 · 2021: 17 · 2020: 22 · 2019: 24 · 2018: 20 · 2017: 2
- FWCI
- 21.26
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- British Journal of Dermatology (publishedVersion)
- PubMed (publishedVersion)
- Minerva Access (University of Melbourne) (submittedVersion)
- Funders
- Financial Markets Foundation for Children
- Asthma Foundation of Victoria
- National Health and Medical Research Council
- Topics
- Health Sciences › Medicine › Dermatology › Dermatology and Skin Diseases
- Health Sciences › Health Professions › Speech and Hearing › Neonatal skin health care
- Health Sciences › Medicine › Dermatology › Contact Dermatitis and Allergies
- Keywords
- atopic dermatitis prevention, skin barrier function, allergen sensitization, transepidermal water loss, skin pH, sebum, skin hydration, family history of allergic disease
- MeSH terms
- Administration, Cutaneous, Allergens, Ceramides, Cholesterol, Dermatitis, Atopic, Drug Administration Schedule, Drug Combinations, Emollients, Fatty Acids, Food Hypersensitivity, Humans, Infant, Infant, Newborn, Pilot Projects, Single-Blind Method, Treatment Outcome
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