Development and clinical assessment of new topical cream containing postbiotic in the treatment of pediatric atopic dermatitis

Abstract

Abstract Introduction: Atopic dermatitis (AD) is the major common chronic inflammatory dermatologic disorder in children. Postbiotics are bioactive compounds derived from probiotics, inanimate microorganisms, and/or their components. In the current study, we aimed to prepare, characterize, and clinically evaluate postbiotic cream in pediatric patients. Methods After preparing different formulations, the formulations were evaluated for stability and physicochemical properties for semi-solids, such as physical properties, viscosity, temperature cycle, and pH. Finally, a formulation that showed better physical properties was chosen for further investigation. The study was performed on patients with AD referred to the outpatient allergy clinic. The primary outcomes were assessed with the SCORAD index and changes in the proportion of children with clinical improvement/no improvement, deterioration, and recurrence rate. Results The final formulation's pH was 6.00 ± 0.02. In addition, the centrifugation test showed that this formulation was completely homogeneous after centrifugation. The temperature cycle test indicated no change in the structure of the cream. After a two-month follow-up, the mean SCOARD score was 50 ± 14.5 at baseline and 27.8 ± 10 at the final visit in the postbiotic group. It was also 43 ± 12 at baseline and 28.2 ± 6 at the final visit in the placebo group. After four months, eleven patients had a recurrence in lesions: 2 in the postbiotic group, 6.9% versus 9 in the placebo group, 30%). Conclusion This study demonstrated that postbiotic formulation is cutaneously acceptable and showed a clinically significant improvement, especially in long-term follow-up.