G S Tiplica1, F Boralevi2, P Konno3, L Malinauskiene4, A Kaszuba5, C Laurens6, M Saint-Aroman7, A Delarue6. 1. 2nd Dermatology Clinic, Colentina Clinical Hospital, "Carol Davila" University of Medicine, Bucharest, Romania. 2. Pediatric Dermatology unit, Hôpital Pellegrin-Enfants, CHU Bordeaux, University Hospital of Bordeaux, Bordeaux, France. 3. East-Tallinn Central Hospital, Tallinn, Estonia. 4. Center of Allergy, Vilnius City Clinical Hospital Antakalnis affiliation, Vilnius, Lithuania. 5. Specjalistyczne Gabinety Lekarskie, "DERMED", Lodz, Poland. 6. Pierre Fabre Dermatologie, Lavaur, France. 7. Pierre Fabre DermoCosmétique, Lavaur, France.
Abstract
BACKGROUND: Emollients are considered as a first-line therapy for the treatment of atopic dermatitis (AD). However, evidence-based proof that the regular use of emollients reduces AD severity is lacking. OBJECTIVE: To assess whether the regular use of emollients results in a reduction in AD severity in children with AD. METHODS: In this multicentre randomized, parallel group, open-label study, children with mild-to-moderate AD were recruited during a flare. After flare resolution with a topical corticosteroid, patients were randomized to V0034CR emollient, reference emollient or no emollient (1:1:1 ratio), for 12 weeks. AD severity was assessed regularly by physicians [Scoring for Atopic Dermatitis (SCORAD) and subcomponents, IGA] and by parents (PO-SCORAD and POEM). RESULTS: A total of 335 patients were randomized to V0034CR (n = 111), reference emollient (n = 116) or no emollient (n = 108). After 12 weeks of treatment, SCORAD score was reduced by 5.28 points in the V0034CR group and by 3.36 points in the reference emollient group compared with the no emollient group (+4 points; P < 0.001 in both emollient groups vs. no emollient group). In a similar manner, PO-SCORAD score was reduced by 4.88 and 2.67 points in the V0034CR and reference emollient groups, respectively, but increased by 2.90 points in the no emollient group (P < 0.001). Similar results were observed for POEM. A continuous decrease in all scores was observed over the 12-week treatment period. At the end of the study, the percentage of patients in complete remission (i.e. without a new flare over the treatment period) was higher in the V0034CR (59.5%) and reference emollient (44.3%) groups than in the no emollient group (29.8%; P < 0.001). CONCLUSION: These results demonstrate that the regular use of emollients in children with mild-to-moderate AD reduces the severity of symptoms and, therefore, support their use as a first-line treatment for these patients.
RCT Entities:
BACKGROUND: Emollients are considered as a first-line therapy for the treatment of atopic dermatitis (AD). However, evidence-based proof that the regular use of emollients reduces AD severity is lacking. OBJECTIVE: To assess whether the regular use of emollients results in a reduction in AD severity in children with AD. METHODS: In this multicentre randomized, parallel group, open-label study, children with mild-to-moderate AD were recruited during a flare. After flare resolution with a topical corticosteroid, patients were randomized to V0034CR emollient, reference emollient or no emollient (1:1:1 ratio), for 12 weeks. AD severity was assessed regularly by physicians [Scoring for Atopic Dermatitis (SCORAD) and subcomponents, IGA] and by parents (PO-SCORAD and POEM). RESULTS: A total of 335 patients were randomized to V0034CR (n = 111), reference emollient (n = 116) or no emollient (n = 108). After 12 weeks of treatment, SCORAD score was reduced by 5.28 points in the V0034CR group and by 3.36 points in the reference emollient group compared with the no emollient group (+4 points; P < 0.001 in both emollient groups vs. no emollient group). In a similar manner, PO-SCORAD score was reduced by 4.88 and 2.67 points in the V0034CR and reference emollient groups, respectively, but increased by 2.90 points in the no emollient group (P < 0.001). Similar results were observed for POEM. A continuous decrease in all scores was observed over the 12-week treatment period. At the end of the study, the percentage of patients in complete remission (i.e. without a new flare over the treatment period) was higher in the V0034CR (59.5%) and reference emollient (44.3%) groups than in the no emollient group (29.8%; P < 0.001). CONCLUSION: These results demonstrate that the regular use of emollients in children with mild-to-moderate AD reduces the severity of symptoms and, therefore, support their use as a first-line treatment for these patients.