An Innovative Oat‐Based Sterile Emollient Cream in the Maintenance Therapy of Childhood Atopic Dermatitis

Abstract

Although emollients are recommended in the management of atopic dermatitis (AD), regimens for emollient maintenance therapy are awaiting validation. We conducted an international, multicenter, open-label trial to assess the effects of a 3-month maintenance treatment regimen with a sterile, preservative-free emollient cream containing oat plantlets in children (ages 6 mos-6 yrs) with moderate AD. After a 14-day run-in stabilization phase using a topical corticosteroid (TCS) treatment of medium potency, 108 children with a SCORing Atopic Dermatitis (SCORAD) index of 20 or less were included in the study. Emollient was applied twice daily for 3 months. Rescue TCS treatment was used only in cases of flare-ups. The SCORAD index, Patient-Oriented SCORAD (PO-SCORAD) index, number of flares, TCS use, and tolerance were assessed at months 1, 2, and 3 (M1, M2, M3). AD severity improved, with a highly significant decrease in the SCORAD and PO-SCORAD indexes at M2 and M3 (p< 0.001). Changes from baseline to M3 were 48.6 ± 73.6% for SCORAD and 29.6 ± 125.3% for PO-SCORAD. The number of flares and TCS use significantly decreased by M3 (both p < 0.001). Very good tolerance was recorded in 100% of children at M2 and M3. Notwithstanding the limitations inherent in open-label trials, twice daily application of the oat-based sterile emollient cream led to a significant improvement of clinical symptoms, evidenced by parallel changes in the SCORAD and PO-SCORAD indexes and fewer flare-ups. Clinical benefit and less TCS use were maintained at M3. Tolerance was very good.

A new topical panthenol-containing emollient for maintenance treatment of childhood atopic dermatitis: results from a multicenter prospective study

“…The results of our study are in accordance with other studies showing that the daily use of skin care products may prevent AD or reduces flare-ups (22)(23)(24)(25)(26). The previously proven skin moisturization and skin barrier restoration potential of NTP-CE is considered responsible for the high success rate of flare prevention recorded in our study (13,14).…”

“…emollient in the maintenance therapy of childhood AD (26). Finally, the decrease in local SCORAD scores during the stabilization phase is in accordance with an earlier study in AD subjects which tested the same preparation (15).…”

Consensus‐based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I

“…Maintenance of stable disease can be obtained with emollients used twice weekly or more frequently in a subset of patients, after an induction of remission with topical corticosteroids. Several studies showed comparable results for intermittent emollient therapy and time to relapse, using comparable study designs in adults and children Emollients should be prescribed in adequate amounts, and these should be used liberally and frequently, in a minimum amount of 250 g per week for adults (3b,C). Emollient bath oils and soap substitutes should also be used.…”

“…Several studies showed comparable results for intermittent emollient therapy and time to relapse, using comparable study designs in adults and children. 75,76 Recommendations • Emollients should be prescribed in adequate amounts, and these should be used liberally and frequently, in a minimum amount of 250 g per week for adults (3b,C).…”

Atopic dermatitis. Interdisciplinary diagnostic and therapeutic recommendations of the Polish Dermatological Society, Polish Society of Allergology, Polish Pediatric Society and Polish Society of Family Medicine. Part I. Prophylaxis, topical treatment and phototherapy

“…Emolienty redukują objawy kliniczne AZS u dzieci i dorosłych, co zapobiega zaostrzeniom i nawrotom wyprysku atopowego. Ponadto podtrzymują stan remisji po jej indukcji miejscowymi preparatami przeciwzapalnymi, wyraźnie zmniejszają ilość stosowanych miejscowych glikokortykosteroidów (mGKS) (steroid sparing effects) [51][52][53][54][55][56][57][58][59][60][61][62].…”