Prevention of atopic dermatitis in high-risk neonates via different types of moisturizer application: A randomized, blinded, parallel, three-group, phase II trial (PAF study).
Journal
Journal of the European Academy of Dermatology and Venereology : JEADV
ISSN: 1468-3083
Titre abrégé: J Eur Acad Dermatol Venereol
Pays: England
ID NLM: 9216037
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
received:
14
03
2023
accepted:
12
07
2023
medline:
29
11
2023
pubmed:
21
7
2023
entrez:
21
7
2023
Statut:
ppublish
Résumé
The effectiveness of moisturizers in preventing infant atopic dermatitis (AD) remains unclear. We previously showed that using 2e moisturizer of commercial moisturizer (Shiseido Japan Co., Ltd.) at least once a day significantly prevented AD in infants as compared with as-needed petroleum jelly. This trial aimed to determine the effectiveness of twice- or once-daily application of Fam's Baby moisturizer (Fam's Inc.) in preventing AD compared with once-daily 2e moisturizer. This trial was a single-centre, three-parallel-group, assessor-blinded, superiority, individually randomized, controlled, phase II trial that was conducted from 25 August 2020 to 28 September 2021. We randomly assigned 60 newborns with at least one parent or sibling who has AD to receive Fam's Baby moisturizer twice daily (Group A) or once daily (Group B), or 2e once daily (Group C) in a 1:1:1 ratio until they were 32 weeks old. The primary outcome was the time of AD onset. Atopic dermatitis was observed in 11/20 (55%), 5/20 (25%) and 10/20 (50%), infants in Groups A, B and C, respectively. Cumulative incidence values for AD according to the Kaplan-Meier method showed that infants in Group B tended to maintain an intact skin for a longer period than those in Group C (median time, not reached [NR] vs. 212 days, log-rank test, p = 0.064). Cox regression analysis showed that the risk of AD tended to be lower in Group B (hazard ratio with group C as control, 0.36; 95% confidential intervals: 0.12-1.06). No serious adverse events occurred in any of the enrolled infants. Fam's Baby moisturizer may better prevent AD than 2e. Further large-scale trials should be performed to confirm the efficacy of Fam's Baby moisturizer in preventing AD in infants.
Sections du résumé
BACKGROUND
BACKGROUND
The effectiveness of moisturizers in preventing infant atopic dermatitis (AD) remains unclear. We previously showed that using 2e moisturizer of commercial moisturizer (Shiseido Japan Co., Ltd.) at least once a day significantly prevented AD in infants as compared with as-needed petroleum jelly. This trial aimed to determine the effectiveness of twice- or once-daily application of Fam's Baby moisturizer (Fam's Inc.) in preventing AD compared with once-daily 2e moisturizer.
METHODS
METHODS
This trial was a single-centre, three-parallel-group, assessor-blinded, superiority, individually randomized, controlled, phase II trial that was conducted from 25 August 2020 to 28 September 2021. We randomly assigned 60 newborns with at least one parent or sibling who has AD to receive Fam's Baby moisturizer twice daily (Group A) or once daily (Group B), or 2e once daily (Group C) in a 1:1:1 ratio until they were 32 weeks old. The primary outcome was the time of AD onset.
RESULTS
RESULTS
Atopic dermatitis was observed in 11/20 (55%), 5/20 (25%) and 10/20 (50%), infants in Groups A, B and C, respectively. Cumulative incidence values for AD according to the Kaplan-Meier method showed that infants in Group B tended to maintain an intact skin for a longer period than those in Group C (median time, not reached [NR] vs. 212 days, log-rank test, p = 0.064). Cox regression analysis showed that the risk of AD tended to be lower in Group B (hazard ratio with group C as control, 0.36; 95% confidential intervals: 0.12-1.06). No serious adverse events occurred in any of the enrolled infants.
CONCLUSION
CONCLUSIONS
Fam's Baby moisturizer may better prevent AD than 2e. Further large-scale trials should be performed to confirm the efficacy of Fam's Baby moisturizer in preventing AD in infants.
Substances chimiques
Emollients
0
Petrolatum
8009-03-8
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2526-2536Subventions
Organisme : Fam's Inc. (Tokyo, Japan)
Informations de copyright
© 2023 European Academy of Dermatology and Venereology.
Références
Kato N, Ohya Y, Ikeda M, Ebihara T, Katayama I, Saeki H, et al. Japanese guidelines for atopic dermatitis 2020. Allergol Int. 2020;69:356-369. https://doi.org/10.1016/j.alit.2020.02.006
Wollenberg A, Barbarot S, Bieber T, Christen-Zaech S, Deleuran M, Fink-Wagner A, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018;32:657-682.
Shima K, Inoue T, Uehara Y, Iwamura M, Fukagawa S, Kuwano T, et al. Non-invasive transcriptomic analysis using mRNAs in skin surface lipids obtained from children with mild-to-moderate atopic dermatitis. J Eur Acad Dermatol Venereol. 2022;36:1477-1485.
Yamamoto-Hanada K, Saito-Abe M, Shima K, Fukagawa S, Uehara Y, Ueda Y, et al. mRNAs in skin surface lipids unveiled atopic dermatitis at one month. J Eur Acad Dermatol Venereol. 2023;10:1385-1395.
Lack G. Epidemiologic risks for food allergy. J Allergy Clin Immunol. 2008;121:1331-1336.
Shoda T, Futamura M, Yang L, Yamamoto-Hanada K, Narita M, Saito H, et al. Timing of eczema onset and risk of food allergy at 3 years of age: a hospital-based prospective birth cohort study. J Dermatol Sci. 2016;84:144-148.
Yamamoto-Hanada K, Kobayashi T, Mikami M, Williams HC, Saito H, Saito-Abe M, et al. Enhanced early skin treatment for atopic dermatitis in infants reduces food allergy. J Allergy Clin Immunol. 2023;152:126-135.
Dharmage SC, Lowe AJ, Matheson MC, Burgess JA, Allen KJ, Abramson MJ. Atopic dermatitis and the atopic march revisited. Allergy. 2014;69:17-27.
Horimukai K, Morita K, Narita M, Kondo M, Kitazawa H, Nozaki M, et al. Application of moisturizer to neonates prevents development of atopic dermatitis. J Allergy Clin Immunol. 2014;134:824-830.
Kelleher MM, Phillips R, Brown SJ, Cro S, Cornelius V, Carlsen KCL, et al. Skin care interventions in infants for preventing eczema and food allergy. Cochrane Database Syst Rev. 2022;14(11):CD013534.
Kottner J, Hillmann K, Fastner A, Conzade R, Heidingsfelder S, Neumann K, et al. Effectiveness of a standardized skin care regimen to prevent atopic dermatitis in infants at risk for atopy: a randomized, pragmatic, parallel-group study. J Eur Acad Dermatol Venereol. 2022;29:540-548.
Chalmers JR, Haines RH, Bradshaw LE, Montgomery AA, Thomas KS, Brown SJ, et al. Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. Lancet. 2020;395:962-972.
Skjerven HO, Rehbinder EM, Vettukattil R, LeBlanc M, Granum B, Haugen G, et al. Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial. Lancet. 2020;395:951-961.
Techasatian L, Kiatchoosakun P. Effects of an emollient application on newborn skin from birth for prevention of atopic dermatitis: a randomized controlled study in Thai neonates. J Eur Acad Dermatol Venereol. 2022;36:76-83.
Chaoimh CN, Lad D, Nico C, Puppels GJ, Wong XFCC, Common JE, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high-risk infants-the STOP-AD randomized controlled trial. Allergy. 2022;78:984-994.
Lowe AJ, Su JC, Allen KJ, Abramson MJ, Cranswick N, Robertson CF, et al. A randomized trial of a barrier lipid replacement strategy for the prevention of atopic dermatitis and allergic sensitization: the PEBBLES pilot study. Br J Dermatol. 2018;178:e19-e21.
Inuzuka Y, Yamamoto-Hanada K, Pak K, Miyoshi T, Kobayashi T, Ohya Y. Effective primary prevention of atopic dermatitis in high-risk neonates via moisturizer application: protocol for a randomized, blinded, parallel, three-group, phase II trial (PAF study). Front Allergy. 2022;3:862620.
Williams HC, Burney PG, Hay RJ, Archer CB, Shipley MJ, Hunter JJ, et al. The U.K. Working Party's diagnostic criteria for atopic dermatitis. Br J Dermatol. 1994;131:383-396.
Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001;10:11-18.
Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol. 2004;140:1513-1519.
Fujisawa T, Nagao M, Hiraguchi Y, Katsumata H, Nishimori H, Iguchi K, et al. Serum measurement of thymus and activation-regulated chemokine/CCL17 in children with atopic dermatitis: elevated normal levels in infancy and age-specific analysis in atopic dermatitis. Pediatr Allergy Immunol. 2009;20:633-641.
Pak K, Uno H, Kim DH, Tian L, Kane RC, Takeuchi M, et al. Interpretability of cancer clinical trial results using restricted mean survival time as an alternative to the hazard ratio. JAMA Oncol. 2017;3:1692-1696.
Uno H, Claggett B, Tian L, Inoue E, Gallo P, Miyata T, et al. Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis. J Clin Oncol. 2014;32:2380-2385.
Ohtani M, Ohtani M, Nozawa A, Matsumoto M, Yamamura Y, Komoda M. A study of the influence of the volume and frequency of application on the efficacy of moisturizers. Jpn J Dermatol. 2012;122:39-43.
Matsumoto Y, Mochimaru N, Yasuda H, Pak K, Kobayashi T, Yamamoto-Hanada K, et al. In vivo analysis of the stratum corneum of Japanese neonates and infants using confocal Raman spectroscopy: a pilot study. Skin Res Technol. 2023;29:e13276.
Ogita H, Yamamoto-Hanada K, Yoshida K, Uehara O, Funaki Y, Kohta M, et al. New skin barrier meter for assessing skin barrier functions: a pilot study in healthy human adults. Skin Res Technol. 2021;27:982-984.
Nowak K, Jabłońska E, Ratajczak-Wrona W. Controversy around parabens: alternative strategies for preservative use in cosmetics and personal care products. Environ Res. 2021;198:110488.
Dréno B, Zuberbier T, Gelmetti C, Gontijo G, Marinovich M. Safety review of phenoxyethanol when used as a preservative in cosmetics. J Eur Acad Dermatol Venereol. 2019;33(Suppl 7):15-24.
Mitsui-Iwama M, Yamamoto-Hanada K, Fukutomi Y, Hirota R, Muto G, Nakamura T, et al. Exposure to paraben and triclosan and allergic diseases in Tokyo: a pilot cross-sectional study. Asia Pac Allergy. 2019;21(9):e5.
Kunkiel K, Sojewska M, Feleszko W. Contact haptens in emollients marketed in two European countries (Poland and Spain). Allergol Immunopathol. 2020;48:814-818.
Ryczaj K, Dumycz K, Spiewak R, Feleszko W. Contact allergens in moisturizers in preventative emollient therapy - a systematic review. Clin Transl Allergy. 2022;12:e12150.
Kolodziej M, Kiewert A, Skudlik C, Brans R. Allergic contact dermatitis to phenoxyethanol: a rare, but possible cause of hand dermatitis. Contact Dermatitis. 2022;86:319-320.
Perkin MR, Logan K, Marrs T, Radulovic S, Craven J, Boyle RJ, et al. Association of frequent moisturizer use in early infancy with the development of food allergy. J Allergy Clin Immunol. 2021;147:967-976.
Yamamoto-Hanada K, Pak K, Sato M, Kram YE, Takemura Y, Inoue N, et al. Associations of frequent emollient use with wheeze and asthma in young Japanese children: a survey of well-child visits. Clin Exp Allergy. 2022;52:451-455.
Inuzuka Y, Yamamoto-Hanada K, Akaishi R, Haruna M, Matsubara M, Saito-Abe M, et al. Dissemination of atopic dermatitis and food allergy information to pregnant women in an online childbirth preparation class. J Allergy Clin Immunol Glob. 2022;1:24-26.