PURPOSE: A study was conducted with a new topical panthenol-containing emollient (NTP-CE) to investigate the efficacy and safety of a 3-month maintenance treatment in infants and children with stabilized mild atopic dermatitis (AD). METHODS: After the stabilization phase (up to 2 months) using a corticosteroid-free topical medical device, 108 subjects (aged 2-49 months) with a SCORing AD (SCORAD) on the target area of <5, were randomized to receive NTP-CE (N = 52) or reference emollient (N = 56) twice-daily for ∼3 months. SCORAD scores, occurrence of flares, and tolerability were assessed at regular intervals. RESULTS: In both groups, local SCORAD decreased during the study with a mean change from baseline (=end of stabilization phase) of -1.2 ± 1.3 (NTP-CE) and -1.0 ± 1.9. Kaplan-Meier analysis provided success rates (i.e. proportion of subjects without flares at study end) of 96 and 77% for the NTP-CE and reference group, respectively (p =.083, log-rank test). Mean time to flare-up was 47 days (range: 29-65) in the NTP CE group and 50 days (6-100). Study products were well tolerated. CONCLUSIONS: Our results indicate that NTP-CE is efficacious and safe when used for maintenance treatment of mild childhood AD.
RCT Entities:
PURPOSE: A study was conducted with a new topical panthenol-containing emollient (NTP-CE) to investigate the efficacy and safety of a 3-month maintenance treatment in infants and children with stabilized mild atopic dermatitis (AD). METHODS: After the stabilization phase (up to 2 months) using a corticosteroid-free topical medical device, 108 subjects (aged 2-49 months) with a SCORing AD (SCORAD) on the target area of <5, were randomized to receive NTP-CE (N = 52) or reference emollient (N = 56) twice-daily for ∼3 months. SCORAD scores, occurrence of flares, and tolerability were assessed at regular intervals. RESULTS: In both groups, local SCORAD decreased during the study with a mean change from baseline (=end of stabilization phase) of -1.2 ± 1.3 (NTP-CE) and -1.0 ± 1.9. Kaplan-Meier analysis provided success rates (i.e. proportion of subjects without flares at study end) of 96 and 77% for the NTP-CE and reference group, respectively (p =.083, log-rank test). Mean time to flare-up was 47 days (range: 29-65) in the NTP CE group and 50 days (6-100). Study products were well tolerated. CONCLUSIONS: Our results indicate that NTP-CE is efficacious and safe when used for maintenance treatment of mild childhood AD.