Influence of the cream with filaggrin activity modulator for dry and sensitive skin in children with mild to moderate severity atopic dermatitis on objective indicators of skin barrier function and disease severity indices

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Abstract

BACKGROUND: Atopic dermatitis is a chronic, relapsing and severely itchy dermatitis that usually occurs in childhood and has a characteristic age-related distribution. Atopic dermatitis is relatively frequent, affecting 10–20% of children in developed countries. Atopic dermatitis in children associated with poor school performance, low self-esteem and family problems. Recent studies show importance in atopic dermatitis pathogenesis of protein filaggrin and modulation of its activity may be a promising direction in the pathogenic therapy of atopic dermatitis.

AIM: to study the effect of a cream for dry, sensitive and atopic skin with a modulator of filaggrin activity on the course of mild and moderate atopic dermatitis.

MATERIAL AND METHODS: An open, prospective, multicentre, non-comparative, single-group clinical trial was organized to test the effectiveness of a cream with a filaggrin activity modulator. The study was on outpatients in the participated centers and included 5 visits with a screening visit 1, and 5th visit ― therapy completion. Cream was used for 12 weeks. In total, the study involved 60 children aged 3 to 18 years with diagnoses of atopic dermatitis of mild and moderate severity. The severity of atopic dermatitis was measured with the SCORAD, EASI, IGA scales, also measured was skin pH and transepidermal water loss (TEWL), as well as the severity of xerosis according to visual analogue scale.

RESULTS: The severity of atopic dermatitis in children whose therapy regimens included Admera cream decreased by 19.6 points according to the SCORAD index, including in children who did not receive mometasone furoate in the therapy schemes, the SCORAD index decreased statistically significantly compared to the baseline data (p <0.001). The overall decline in the EASI index ― by 3.0 points, the IGA global assessment index ― by 2.0 points, the severity of xerosis decreased by 3 points (in all cases, p <0.001). Transepidermal water loss decreased (by 4.5 g/m2 per hour, p <0.001); Skin pH did not change (difference 0.02, p=0.34). The smell was rated as "excellent" by 86.7% (95% CI 75.4–94.1), the consistency ― by 83.3% (95% CI 71.5–91.7) of the respondents, and overall satisfaction was noted by ― 88.3% (95% CI 77.4–95.2) of the respondents.

CONCLUSION: Сream for dry and sensitive skin with a modulator of filaggrin activity during the study showed good efficacy and tolerability and can be used in atopic dermatitis treatment regimens as a basic care product, both during exacerbation and remission.

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About the authors

Denis V. Zaslavsky

Saint-Petersburg State Pediatric Medical University

Author for correspondence.
Email: venerology@gmail.com
ORCID iD: 0000-0001-5936-6232
SPIN-code: 5832-9510

MD, Dr. Sci. (Med.), Professor

Russian Federation, 2 Litovskay street, 194100 Saint-Peterburg

Anna N. Barinova

North-Western State Medical University named after I.I. Mechnikov; City Hospital № 26

Email: anna_n_barinova@mail.ru
ORCID iD: 0000-0002-8180-9340
SPIN-code: 2010-4354

MD, Dr. Sci. (Med.), Professor

Russian Federation, Saint Petersburg; Saint Petersburg

Sviatoslav L. Plavinskij

North-Western State Medical University named after I.I. Mechnikov

Email: s.plavinskij@szgmu.ru
ORCID iD: 0000-0001-9159-6177
SPIN-code: 5660-4661

MD, Dr. Sci. (Med.), Professor

Russian Federation, Saint Petersburg

Maria I. Zelyanina

The Pierre Wolkenstein French Dermatological Clinic

Email: m.zelianina@rambler.ru
ORCID iD: 0000-0002-0172-9763
SPIN-code: 3201-9685

MD

Russian Federation, Saint Petersburg

Irina N. Zakharova

Russian Medical Academy of Continuous Professional Education

Email: zakharova-rmapo@yandex.ru
ORCID iD: 0000-0003-4200-4598
SPIN-code: 4357-3897

MD, Dr. Sci. (Med.), Professor

Russian Federation, Moscow

Irina V. Berezhnaya

Russian Medical Academy of Continuous Professional Education

Email: berezhnaya-irina26@yandex.ru
ORCID iD: 0000-0002-2847-6268

MD, Cand. Sci. (Med.), Associate Professor

Russian Federation, Moscow

Natalia V. Shartanova

National Research Center - Institute of Immunology

Email: nshartanova@yandex.ru
ORCID iD: 0000-0002-1197-9002
SPIN-code: 6483-8901

MD, Dr. Sci. (Med.)

Russian Federation, Moscow

Olga I. Sidorovich

National Research Center - Institute of Immunology

Email: instimmun@yandex.ru
ORCID iD: 0000-0003-1000-0664
SPIN-code: 9757-8172

MD, Cand. Sci. (Med.), Senior Research Associate

Russian Federation, Moscow

References

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  5. Dvornyk V, Ponomarenko I, Belyaeva T, et al. Filaggrin gene polymorphisms are associated with atopic dermatitis in women but not in men in the Caucasian population of Central Russia. PLoS One. 2021;16(12):e0261026. doi: 10.1371/journal.pone.0261026
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Supplementary files

Supplementary Files
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1. Fig. 1. Dynamics of the median value of the total score of the SCORAD index.

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2. Fig. 2. Percentage improvement of the SCORAD index on visits 2–5. The designation SCORAD 99 means the index SCORAD 100.

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3. Fig. 3. Dynamics of the median value of the assessment of the severity and prevalence of atopic dermatitis according to the EASY index.

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4. Fig. 4. Percentage improvement of the EASI index on visits 2–5. The designation EASY 99 means the index EASI 100.

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5. Fig. 5. Percentage improvement of the IGA global Assessment index on visits 2–5. The designation IGA 99 means the IGA 100 index.

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6. Fig. 6. Percentage improvement in estimates of the intensity of xerosis by VAS on visits 2–5. The designation VAS 99 means the score is VAS 100.

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7. Fig. 7. Dynamics of the values of the skin hydration assessment index by the transepidermal water loss index using vaporimetry (g/m2 per hour) throughout the study.

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8. Fig. 8. Percentage improvement in the assessment of transepidermal water loss on visits 2–5. The designation ТЭПВ 99 means an improvement of ТЭПВ 100.

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9. Fig. 9. Evaluation of the effectiveness of the use of cosmetics on a 5-point Likert scale by parents/adoptive parents of patients on 84±2 days of therapy.

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10. Fig. 10. Evaluation of the organoleptic properties of the cosmetic product ― smell.

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11. Fig. 11. Evaluation of the organoleptic properties of a cosmetic product ― texture.

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12. Fig. 12. Atopic dermatitis and nummular eczema of the hands. Before treatment (а) and after 1 month (b).

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13. Fig. 13. Atopic dermatitis in the area of the folds of the wrist joint. Before treatment (а) and 3 months later (b).

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