COMPARATIVE, RANDOMIZED, DOUBLE-BLINDED STUDY ASSESSING THE EFFICACY OF A NEW KIND OF DERMOCOSMETIC PRODUCT CONTAINING SKIN BARRIER THERAPY® ON INFANTS AND CHILDREN WITH MODERATE ATOPIC DERMATITIS

Gayraud F.¹, Imko-Walczuk B.², Sayag M.¹, Jourdan E.^1
1Laboratoire BIODERMA, Scientific Affairs and Research Department, Lyon, France
²Coordinating Investigator, Gdansk, Poland

BACKGROUND

Atopic Dermatitis (AD) is a recurrent inflammatory dermatosis linked to epidermal barrier dysfunction deriving from 2 causes: a genetic predisposition to a decrease of structural proteins (i.e.,filaggrin)^[1;2] and the local impact of pro-inflammatory cytokins^[3]. The number of AD cases increased threefold in industrialized countries during the 20 previous years. AD affects about 20% of babies and children. It begins during the 2nd and 3rd month of life and then evolves with outbreaks^[4]. After 7 years, outbreaks often disappear but the skin remains dry and sensitive.

METHODS

The purpose of this study was to assess the efficacy and tolerance of a new kind of dermocosmetic product which biologically reconstructs the skin barrier function and prevents s.aureus from attachment on atopic skin (Skin Barrier Therapy^® patent). This study was performed versus basic emollient, containing 3% glycerin (with moisturizing effect), in children with moderate AD (SCORAD ≤ 40) over six months of twice daily use. 130 subjects (65 in each group) aged from 6 months to 15 years were included over one year. They had between 3 and 6 atopic relapses during 6 months before the beginning of the study.

Three visits under dermatologist control were planned during the six months study. Subjects presenting a moderate AD relapse were treated for 7 to 21 days with topical dermocorticoids or immunosuppressors. Then, they were included in the in-use part and randomized in two groups. The main assessment were: AD clinical signs (SCORAD and PO-SCORAD), number of relapses, dryness and quality of life.

RESULTS

Compared to the basic emollient, the product showed a significant decrease of SCORAD (7.2 vs 3.5, p< 0.05) and PO-SCORAD (score 7.7 vs 4.7, p< 0.05) after 6 months.

Thanks to this improvement, the number of relapses and their intensity decreased in the tested product group. The skin moisturizing improved: 72% of the subjects did not have any more dryness after 168 days vs only 56% for the basic emollient. All subjects agreed that itching sensations were reduced at the end of the study.
The quality of life of children and of the whole family significantly improved after 6 months of twice daily use (IDQoL: -89% and DFI: -92%, p< 0.05) compared to the basic emollient (IDQoL: -27% and DFI: -71%). The AD has no more impact already after 4 months.

CONCLUSION

This new dermocosmetic product significantly decreases the clinical signs of AD after the treatment of a relapse and improves the skin state. This product which biologically recreates the barrier function of the skin and prevents s.aureus from attachment on atopic skin represents a new approach of AD treatment in association with dermocorticoids or immunosuppressors and is highly recommended because of its clinical efficacy and good tolerability. For the 1st time, this comparative study demonstrates that this new kind of dermocosmetic product can keep AD under control compared to a basic emollient.

References :
[1] Pellerin et al. Defects of filaggrin like proteins in both lesional and non lesional atopic skin. J Allergy Clin Immunol 2013 Apr;131(4):1094-102
[2] Taïeb 2008 La Dermatite Atopique. Dermatol. et infections sex. Transmissibles, Saurat, Grosshans, Laugier, Lachapelle, 5° édition, Masson
[3] Bieber 2008 Atopic dermatitis. The New England journal of medicine, vol. 358, no. 14, pp.1483–94
[4] Le Maitre 2007 Dermatite atopique du nourrisson et de l’enfant. Nouvelles Dermatologiques; 26 (1) : 1-16

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