Emulsion containing a chitosan derivative in children with mild atopic dermatitis: A randomized controlled trial.

Background: Recently, partially myristoylated carboxymethyl chitosan (PMCMC) was developed in Japan. To compare the efficacy and safety of PMCMC-containing emulsion and petrolatum, we conducted a randomized controlled trial.

Methods: Eligible patients were children aged 1-<6 years who had mild atopic dermatitis (with Eczema Area and Severity Index [EASI] ≤7.0). Participants were randomly assigned (1:1) to receive PMCMC-containing emulsion or petrolatum. Study treatments were applied to the body twice daily for 8 weeks. The co-primary endpoints were the changes in EASI and total score of Quality of life in Primary Caregivers of children with Atopic Dermatitis (QP-CAD) from baseline to the end of the treatment.

Results: Between February 2020 and August 2022, 80 participants (39, emulsion group; 41, petrolatum group) were enrolled and included in the analysis. The decrease in EASI at the end of the treatment was greater in the emulsion group than in the petrolatum group with the LS mean (SE) change of -0.74 (0.31) in the emulsion group and 0.29 (0.31) in the petrolatum group (difference -1.02, 95% CI -1.90 to -0.15; p = .022). The decrease in total QP-CAD was also greater in the emulsion group than in the petrolatum group with the LS mean (SE) change of -1.63 (1.08) and 1.55 (1.01), respectively (difference -3.18, 95% CI -6.13 to -0.22; p = .035). All adverse events in the emulsion group were mild.

Conclusion: PMCMC-containing emulsion significantly improved disease severity of children and quality of life of caregivers compared with petrolatum.

Trial Registration: https://jrct.mhlw.go.jp/-number: jRCTs031190201.