title: 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.
authors.affiliation: Pierre Fabre Applied Skin Research Centre, Pierre Fabre Dermo Cosmétique, Toulouse, France.
authors.forename: Valerie
authors.initials: V
authors.lastname: Mengeaud
authors.forename: Chloe
authors.initials: C
authors.lastname: Phulpin
authors.forename: Adeline
authors.initials: A
authors.lastname: Bacquey
authors.forename: Franck
authors.initials: F
authors.lastname: Boralevi
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Schmitt
authors.forename: Alain
authors.initials: A
authors.lastname: Taieb
mesh_terms: D000287:Administration, Topical; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000704:Analysis of Variance; D018554:Avena; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000175:diagnosis* / Q000188:drug therapy*; D004643:Emollients / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D038622:Internationality; D008297:Male; D016011:Normal Distribution; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D004643:Emollients