In a multicenter, randomized, double-blind, vehicle-controlled trial, 106 infants and children with mild to moderate atopic dermatitis applied hydrolipidic cream MAS063DP or vehicle three times a day to past, current, or "reasonable future" sites as monotherapy for 43 days (J. Pediatr. 2008;152:8549). The mean age of subjects was 5 years.
One target lesion was chosen by investigators for evaluation and photography (mostly identified on extremities). Success was defined as reaching an IGA score of 0 (clear) or 1 (almost clear).
In an intention-to-treat analysis, 53 of 69 subjects (77%) in the hydrolipidic cream group achieved a score of 0 or 1 at day 22, compared with none in the vehicle group. "The vehicle used in the study wasn't your normal petrolatum vehicle," Dr. Krakowski noted. "It was the vehicle the hydrolipidic cream came in."
Pruritus, EASI scores, subject and caregiver assessment of global response, onset and duration of itch relief, and need for rescue medication were all significantly improved in the treatment group, compared with the vehicle group.
"I think barrier products could be helpful as adjuvant treatment for atopic dermatitis," he commented. "I think the cost of these products needs to be reconciled with their cost-effectiveness; most of these products may not be covered by insurance. We also need better head-to-head, long-term, pediatric-specific trials to demonstrate efficacy of these products for treating flares directly and for maintenance therapy over the long term."
Dr. Krakowski disclosed having had no relevant conflicts of interest.