Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial

Skjerven, Håvard Ove; Rehbinder, Eva Maria; Vettukattil, Riyas; LeBlanc, Marissa; Granum, Berit; Haugen, Guttorm; Hedlin, Gunilla; Landrø, Linn; Marsland, Benjamin J.; Rudi, Knut; Sjøborg, Kathrine Donvold; Söderhäll, Cilla; Staff, Anne Cathrine; Carlsen, Kai Håkon; Asarnoj, Anna; Bains, Karen Eline Stensby; Carlsen, Oda C. Lødrup; Endre, Kim M.A.; Granlund, Peder Annæus; Hermansen, Johanne Uthus; Guðmundsdóttir, Hrefna; Hilde, Katarina; Håland, Geir; Kreyberg, Ina; Olsen, Inge Christoffer; Mägi, Caroline Aleksi Olsson; Nordhagen, Live Solveig; Saunders, Carina Madelen; Skrindo, I.; Tedner, Sandra G.; Værnesbranden, Magdalena R.; Wiik, Johanna; Jonassen, Christine Monceyron; Nordlund, Björn

doi:10.1016/s0140-6736(19)32983-6

Cited by 198 publications

(254 citation statements)

References 32 publications

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“…Both studies showed no significant reduction in the incidence of AD, and in the BEEP study, there was an increased rate of infections and a trend toward increased food allergy in the intervention group. 113,114 Similarly, an RCT by Dissanayake et al compared the incidence of AD and FA in the first year of life in infants treated with synbiotics and an emollient (alone or in combination) and controls and found no statistical difference. 163 The negative findings in these studies were surprising given the pilot study findings, and the authors discussed various reasons as to why this might have occurred including low adherence rate with the intervention (especially PreventADALL), contamination of the control arm (BEEP), and the type of emollient used.…”

Section: The Role Of Emollients To Pre Vent the De Velopment Of Foomentioning

confidence: 99%

Epicutaneous sensitization in the development of food allergy: What is the evidence and how can this be prevented?

Brough

Nadeau

Sindher

et al. 2020

Allergy

191

168

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There is increasing evidence regarding the importance of allergic sensitization through the skin. In this review, we provide an overview of the atopic march and immune mechanism underlying the sensitization and effector phase of food allergy. We present experimental models and human data that support the concept of epicutaneous sensitization and how this forms one half of the dual‐allergen exposure hypothesis. We discuss specific important elements in the skin (FLG and other skin barrier gene mutations, Langerhans cells, type 2 innate lymphoid cells, IL‐33, TSLP) that have important roles in the development of allergic responses as well as the body of evidence on environmental allergen exposure and how this can sensitize an individual. Given the link between skin barrier impairment, atopic dermatitis, food allergy, allergic asthma, and allergic rhinitis, it is logical that restoring the skin barrier and prevention or treating atopic dermatitis would have beneficial effects on prevention of related allergic diseases, particularly food allergy. We present the experimental and human studies that have evaluated this approach and discuss various factors which may influence the success of these approaches, such as the type of emollient chosen for the intervention, the role of managing skin inflammation, and differences between primary and secondary prevention of atopic dermatitis to achieve the desired outcome.

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Section: The Role Of Emollients To Pre Vent the De Velopment Of Foomentioning

confidence: 99%

Epicutaneous sensitization in the development of food allergy: What is the evidence and how can this be prevented?

Brough

Nadeau

Sindher

et al. 2020

Allergy

191

168

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“…However, prevention of AD was not proven in the BEEP study [11] in high-risk neonates in the UK and in the PreventADALL study [12] in general populations of Norway and Sweden. Once daily moisturizer was proposed in the study protocols of these two previous studies [11,12]. Reasons for the inconsistency in results for moisturizer interventions might be due to different countries and cultures, different types of moisturizers, and differences in adherence.…”

Section: Discussionmentioning

confidence: 99%

“…As mentioned above, two RCTs provided evidence that protecting the skin barrier with a moisturizer applied at the beginning of the neonatal period prevented development of infantile AD [9,10]. However, prevention of AD was not proven in the BEEP study [11] in high-risk neonates in the UK and in the PreventADALL study [12] in general populations of Norway and Sweden. Once daily moisturizer was proposed in the study protocols of these two previous studies [11,12].…”

Section: Discussionmentioning

confidence: 99%

“…Recently, the BEEP study showed that application of the moisturizer Doublebase Gel (Dermal Laboratories, Herts, UK) or Diprobase Cream (Bayer, Berks, UK), at least once daily from early birth had no preventive effect on AD (adjusted relative risk: 0.95 95% CI: 0.78-1.16, p=0.61) [11]. Similarly, the PreventADALL study (2×2 factorial design), which tested two primary prevention strategies of skin care and early food introduction, showed that an oil bath and application of a moisturizer to the infant's face (Ceridal cream) at least 5 days per week from 0.5 to 9 months of age was not effective in preventing AD [12]. Therefore, unfortunately, these two large RCTs could not con rm the e cacy of moisturizer application for primary prevention of AD.…”

Section: The Possibility Of Percutaneous Sensitization Via In Ammatormentioning

confidence: 99%

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Effective Prevention of Atopic Dermatitis by Applying Fam’s Baby Moisturizer Twice Daily or Once Daily Compared with 2e Moisturizer Once Daily in High-Risk Neonates: Study Protocol for A Randomized, Blinded, Parallel, Three Group, Phase II Trial (PAF Study)

Inuzuka¹,

Yamamoto‐Hanada²,

Pak³

et al. 2020

Preprint

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BackgroundAtopic dermatitis (AD) is a chronic and inflammatory skin disease that commonly affects young children. AD causes health-related burdens associated with pruritus and poor quality of life. The efficacy of moisturizer application shows inconsistency on primary prevention of AD according to previous randomized, controlled trials. Which moisturizer is effective and how often moisturizer should be applied to prevent development of AD in infants remain unclear. We hypothesize that twice daily application of moisturizer using Fam’s Baby is more effective than once daily application and that a sufficient amount of moisturizer application is effective for preventing development of AD in neonates and infants. Therefore, this study aimed to examine whether applying Fam’s Baby twice daily or once daily prevents AD compared with 2e moisturizer once daily in neonates and infants with at least one parent or sibling who has had atopic dermatitis.MethodsThis study is a single-center, three-parallel group, assessor-blind, superiority, individually randomized, controlled, phase II trial. A newborn with at least one parent or sibling who has had AD is randomly assigned to application of Fam’s Baby twice daily, Fam’s Baby once daily, or 2e once daily in a 1:1:1 ratio until 32 weeks old. The primary outcome is the time to the first onset of AD during administration of the moisturizer.DiscussionThis is the first phase II randomized, controlled trial in Japan to investigate whether applying moisturizer (Fam’s Baby) twice daily or once daily can prevent the incidence of AD compared with another moisturizer (2e) once daily in high-risk neonates. In this study, we will use 2e once daily as control moisturizer to confirm the efficacy for primary prevention of AD as found in our previous trial. Evaluation of application of moisturizers for preventing AD in this study is expected to contribute to a reduction in the prevalence of AD and a reduction in health care costs. Trial registrationJapan Registry of Clinical Trials (jRCT); ID: jRCTs031200070. Registered on 20 July 2020.

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“…We need to wait a little longer for the food allergy results from the Preventall study. Please keep safe in the midst of the CORVID‐19 pandemic 8,9 …”

Section: High Fev1 (N = 13) Low Fev1 (N = 14) Control (N = 10) P‐valuementioning

confidence: 99%

Balancing laissez‐faire and paranoia in patients at risk of anaphylaxis

Roberts

2020

Clin Experimental Allergy

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Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial

Cited by 198 publications

References 32 publications

Epicutaneous sensitization in the development of food allergy: What is the evidence and how can this be prevented?

Epicutaneous sensitization in the development of food allergy: What is the evidence and how can this be prevented?

Effective Prevention of Atopic Dermatitis by Applying Fam’s Baby Moisturizer Twice Daily or Once Daily Compared with 2e Moisturizer Once Daily in High-Risk Neonates: Study Protocol for A Randomized, Blinded, Parallel, Three Group, Phase II Trial (PAF Study)

Balancing laissez‐faire and paranoia in patients at risk of anaphylaxis

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