A cream that combines 1% ectoine and .1% hyaluronic acid (ECZAID®) achieved superior results compared with a vehicle cream in children with mild to moderate atopic dermatitis. Details of the randomized clinical trial were published in Pediatric Dermatology.
The cream has been shown to improve skin lipid barrier and restore dry, sensitive skin in adults. The researchers examined how the cream would perform in patients aged 18 years and younger.
The randomized, observer-blind, multicenter trial included 70 patients between the ages of 2 and 18 years diagnosed with mild to moderate atopic dermatitis. Due to incomplete assessment data and informed consent withdrawal, 13 of these patients were excluded from the study.
Researchers evenly divided patients into either an ECZAID group or a vehicle cream group. Cream was applied topically twice a day for 28 days. Patients visited a clinic for assessments at baseline, 2 weeks, and 4 weeks, respectively. The primary efficacy endpoint was the mean change from baseline in objective SCORing AD at 4 weeks.
At 4 weeks, the researchers found patients receiving ECZAID achieved superior clinical improvement compared with patients who received the vehicle cream (mean difference in change from baseline=6.62; 95% CI 8.25 to 4.99; <.001). The center by treatment interaction was insignificant (P =.087).
Patients treated with ECZAID had lower Investigator’s Global Assessment and SCORing AD scores compared with the vehicle cream group. Adverse events were minor and included some burning, redness, and itching upon the first application.
Researchers acknowledge that a significant SCORing AD difference between the 2 groups does not equate to clinical significance. “Further studies need to evaluate the long-term efficacy and safety of the cream and the potential role of the other components in the management of children with mild-to-moderate AD before its use for the treatment of AD is widely accepted,” the researchers concluded. However, to the investigators, the results indicate its promise as an effective treatment for pediatric patients with atopic dermatitis.
Alexopoulos A, Dakoutrou M, Nasi L, et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis [published online ahead of print, 2022 Aug 29]. Pediatr Dermatol. 2022;10.1111/pde.15117. doi:10.1111/pde.15117