Clinical and hardware evaluation of moisturizing properties and tolerability of a emollient cream with filagrinol (“Admera”) in atopic dermatitis in children

Objective. Evaluate the possibility of using a cream with 5 % filagrinol ("Admera") in children (0-18 years old) as an emollient in atopic dermatitis (AtD) and receive hardware measurements of skin hydration.

Materials and methods. Open interventional study in parallel groups of children with AtD 0-18 years old (n = 72, median age 6 [3.75; 7.0] years). 2 equal groups: group 1 received methylprednisolone cream 1 time daily on lesions for 14 days + Admera emollient on the other skin; group 2 received the same treatment + cream with filagrinol 5 % applied from day 5 on the lesions.

Results. Standard therapy with topical steroids and emollients was effective. The severity indices during steroid + emollient treatment decreased significantly: EASI 11.5 [6.0; 17.0] vs 2 [1; 3.8] scores, p < 0.001; skin lesion area from 17.5 % [10.0; 26.8 %] to 3.5 % [1.25; 6.0 %], p < 0.001; IGA score — 2 [2; 3] vs 1 [1; 2], p < 0.01.

The total itching score for AtD (max 10) became significantly lower with therapy: nocturnal itching decreased from 3 [1; 7] to 1 [1; 3] and daytime itching from 4 [3; 7] to 2.5 [1; 4] points, p < 0.01.

The mean values of hardware-measured skin hydration outside the lesion areas were 8 [6.0; 12.0] units at baseline. After 14 days of emollient, hydration of dry clear skin increased to 10 [8.0; 15.0] units (p = 0,017). The hydration of the skin on the affected areas increased significantly from 8 [6; 10] to 12.0 [8; 15] units (p = 0.001).

The patients' organoleptic evaluation of the cream was 4.48 (max 5). No serious or moderate adverse events (AEs) were reported in this study. In 11.3 % of cases, the skin itching was detected, but resolved rapidly without treatment.

Conclusion. The cream with 5 % filagrinol (“Admera”) significantly improved skin hydration, as measured instrumentally, in the area of dermatitis and dry skin without ones. The cream caused no significant adverse reactions and could be used together with topical steroids.

1. Smolkin YS, Balabolkin II, Gorlanov IA, et al. Consensus document APAIR: atopic dermatitis in children — update 2019 (short version). Part 1. Allergology and Immunology in Pediatrics. 2020; 60 (1): 4-25. https://doi.org/10.24411/2500-1175-2020-10001.

2. Tokura Y, Hayano S. Subtypes of atopic dermatitis: From phenotype to endotype. Allergology International. 2022; 71 (1): 14-24. https://doi.org/10.1016/j.alit.2021.07.003.

3. Cabanillas B, Novak N. Atopic dermatitis and filaggrin. Curr Opin Immunol. 2016; 42: 1-8. https://doi.org/10.1016/j.coi.2016.05.002.

4. McGrath JA, Uitto J. The filaggrin story: novel insights into skin-barrier function and disease. Trends Mol Med. 2008; 14 (1): 20-27. https://doi.org/10.1016/j.molmed.2007.10.006.

5. Carson CG, Rasmussen MA, Thyssen JP, Menne T, Bisgaard H. Clinical Presentation of Atopic Dermatitis by Filaggrin Gene Mutation Status during the First 7 Years of Life in a Prospective Cohort Study. Simon M, ed. PLoS ONE. 2012; 7 (11): e48678. https://doi.org/10.1371/journal.pone.0048678.

6. Čepelak I, Dodig S, Pavić I. Filaggrin and atopic march. Biochem Med (Zagreb). 2019; 29 (2): 020501. https://doi.org/10.11613/BM.2019.020501.

7. Smolkina OY et al. DNA Methylation Analysis of Lesional and Non-lesional Skin in Adult Patients with Atopic Dermatitis. Molecular medicine. 2021; (1): https://doi.org/10.29296/24999490-2021-01-08. (In Russ.)

8. Tamrazova OB, Glukhova EA. Unique molecule filaggrin in epidermal structure and its role in the xerosis development and atopic dermatitis pathogenesis. Klinicheskaya Dermatologiya i Venerologiya. 2021; 20 (6): 102-110. (In Russ.) https://doi.org/10.17116/klinderma202120061102

9. Smolkin YS, Migacheva NB, Smolkina OY. Maintenance of remission and prevention of disease flares in children with atopic dermatitis. Position paper of the Association of Children's Allergists and Immunologists of Russia. Consilium Medicum. 2020; 2: 38-45. https://doi.org/10.26442/26586630.2020.2.200149. (In Russ.)

10. VanZuuren EJ, Fedorowicz Z, Christensen R, Lavrijsen APM, Arents BWM. Emollients and moisturisers for eczema (Review). Cochrane Database of Systematic Reviews. 2019; CD012119(2): 426. https://doi.org/10.1002/14651858.CD012119.pub2.

11. Wollenberg A, Kinberger M, Arents B, et al. European guideline (EuroGuiDerm) on atopic eczema — part II: non-systemic treatments and treatment recommendations for special AE patient populations. Journal of the European Academy of Dermatology and Venereology. 2022; 36 (11): 1904-1926. https://doi.org/10.1111/jdv.18429.

12. Snarskaya ES, BratkovskayaAV. Novel filagrinol-containing emollient. Vestnik dermatologii i venerologii. 2022; 98 (5): 65-89. (In Russ.) https://doi.org/10.25208/vdv1342.

13. Lichterfeld A, Hauss A, Surber C, Peters T, Blume-Peytavi U, Kottner J. Evidence-Based Skin Care: A Systematic Literature Review and the Development of a Basic Skin Care Algorithm. J Wound Ostomy Continence Nurs. 2015; 42 (5): 501-524. https://doi.org/10.1097/WON.0000000000000162.

14. Coderch L, Lopez O, de la Maza A, Parra JL. Ceramides and skin function. Am J Clin Dermatol. 2003; 4 (2): 107-129. https://doi.org/10.2165/00128071-200304020-00004.

15. Perrett KP, Peters RL. Emollients for Prevention of Atopic Dermatitis in Infancy. Vol 395. Lancet Publishing Group; 2020. https://doi.org/10.1016/S0140-6736(19)33174-5.

16. Murashkin NN, Ivanov RA, Ambarchian ET, Epishev RV, Materikin AI, Opryatin LA, Savelova AA. Filaggrin and Atopic Dermatitis: Clinical and Pathogenetic Parallels and Therapeutic Possibilities. Voprosy sovremennoi pediatrii — Current Pediatrics. 2021; 20 (5): 435-440. (In Russ.) https://doi.org/10.15690/vsp.v20i5.2320.

17. Заславский ДВ., Соболев АВ., Скрек СВ., Юновидова АА, Зелянина МИ, Машука ДМ, Стародубцева ДА, Шиманская МЛ, Зяблова ДД, Хамнагдаева АС. Нормализация эпидермального барьера как способ патогенетической терапии атопического дерматита у детей. Вестник дерматологии и венерологии. 2021; 97 (5): 52-65. https://doi.org/10.25208/vdv1255 (InRuss.).

18. Заславский ДВ., Баринова АН, Плавинский СЛ, Зелянина МИ, Захарова ИН, Бережная ИВ, Шартанова НВ, Сидорович ОИ. Влияние крема для сухой и чувствительной кожи с модулятором активности филаггрина на объективные показатели барьерной функции кожи и индексы тяжести заболевания у пациентов детского возраста с атопическим дерматитом легкой и средней степени тяжести. Российский журнал кожных и венерических болезней. 2023; 26 (1): 25-39. https://doi.org/10.17816/dv122220.

19. Roduit C, Frei R, Depner M, et al. Phenotypes of Atopic Dermatitis Depending on the Timing of Onset and Progression in Childhood. JAMA Pediatr. 2017; 171 (7): 655-662. https://doi.org/10.1001/jamapediatrics.2017.0556.

20. Carson CG, Rasmussen MA, Thyssen JP, Menne T, Bisgaard H. Clinical presentation of atopic dermatitis by filaggrin gene mutation status during the first 7 years of life in a prospective cohort study. PLoS One. 2012; 7 (11): e48678. https://doi.org/10.1371/journal.pone.0048678.

21. Tsuge M, Ikeda M, Matsumoto N, Yorifuji T, Tsukahara H. Current Insights into Atopic March. Children (Basel). 2021; 8 (11): 1067. https://doi.org/10.3390/children8111067.

22. SmolkinYuS, Masalskiy SS, Zaytseva GV, Smolkina OYu. Allergic sensitization in children with atopic dermatitis in the first 2 years of life according to the results of skin tests. Voprosy pitaniia [Problems of Nutrition]. 2022; 91: 50-60. (In Russ.) https://doi.org/10.33029/0042-88332022-91-6-50-60.

23. Prescott SL, Pawankar R, Allen KJ. et al. A global survey of changing patterns of food allergy burden in children. World Allergy Organ J 6, 1-12 (2013). https://doi.org/10.1186/1939-4551-6-21.

24. El Hachem M, Di Mauro G, Rotunno R, et al. Pruritus in pediatric patients with atopic dermatitis: a multidisciplinary approach — summary document from an Italian expert group. Ital J Pediatr. 2020; 46: 11. https://doi.org/10.1186/s13052-020-0777-9.

25. Bergera-Virassamynaik S, Ardiet N, Sayag M. Evaluation of the Efficacy of an Ecobiological Dermo-Cosmetic Product to Help Manage and Prevent Relapses of Eyelid Atopic Dermatitis. Clin CosmetInvestig Dermatol. 2023; 16: 677-686. https://doi.org/10.2147/CCID.S401576.

26. Berdyshev E, Goleva E, Bissonnette R, et al. Dupilumab significantly improves skin barrier function in patients with moderate-to-severe atopic dermatitis. Allergy. 2022; 77 (11): 3388-3397. https://doi.org/10.1111/all.15432.

27. Danby SG, Chittock J, Brown K, Albenali LH, Cork MJ. The effect of tacrolimus compared with betamethasone valerate on the skin barrier in volunteers with quiescent atopic dermatitis. Br J Dermatol. 2014; 170 (4): 914-921. https://doi.org/10.1111/bjd.12778.

28. Grimalt R, Mengeaud V, Cambazard F, Study Investigators' Group. The steroid-sparing effect of an emollient therapy in infants with atopic dermatitis: a randomized controlled study. Dermatology. 2007; 214 (1): 61-67. https://doi.org/10.1159/000096915.

29. Araviiskaia E, Pincelli C, Sparavigna A, Luger T. The Role of a Novel Generation of Emollients, ‘Emollients Plus', in Atopic Dermatitis. Clin Cosmet Investig Dermatol. 2022; 15: 2705-2719. Published 2022 Dec 14. https://doi.org/10.2147/CCID.S389697.

30. Magnolo N, Jaenicke T, Tsianakas A, et al. Comparison of different skin care regimens in patients with moderate to severe atopic dermatitis receiving systemic treatment: A randomized controlled trial [published online ahead of print, 2023 Apr 24]. J Eur Acad Dermatol Venereol. 2023; 10.1111/jdv.18949. https://doi.org/10.1111/jdv.18949.