Dermatology and Therapy (Aug 2024)

Efficacy of a Multi-lamellar Emulsion Containing a Synthetic Sphingosine Kinase 1 Activator and Pseudoceramide in Patients with Atopic Dermatitis: A Randomized Controlled Trial

  • So Yeon Lee,
  • Jin Seo Park,
  • Daehwan Kim,
  • Wonseok Jeong,
  • Chenghwan Hwang,
  • Hye One Kim,
  • Chun Wook Park,
  • Bo Young Chung

DOI
https://doi.org/10.1007/s13555-024-01254-5
Journal volume & issue
Vol. 14, no. 9
pp. 2591 – 2605

Abstract

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Abstract Introduction Patients with atopic dermatitis (AD) have impaired barrier function, which decreases skin hydration, weakens their defense against microorganisms, and culminates in increased inflammatory responses. Here, we conducted a clinical trial to evaluate the efficacy of a multi-lamellar emulsion (MLE) containing the pseudoceramide PC-9S and a synthetic sphingosine kinase 1 (SPHK1) activator, Defensamide™, in improving mild-to-moderate atopic dermatitis. Methods Forty patients aged ≥ 2 years were randomized into a combined-therapy group treated with the MLE containing PC-9S and Defensamide™ plus a topical corticosteroid and a topical-corticosteroid-only group. Assessments based on therapeutic methods included the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), transepidermal water loss (TEWL), stratum corneum hydration (SCH), skin dryness, a visual analogue scale (VAS) of itchiness, a VAS of sleep disturbance, patient satisfaction, and the Dermatology Life Quality Index (DLQI). Results Thirty-eight patients completed this study. In the combined-therapy group, significant improvements in clinical and instrumental measures such as EASI scores, skin hydration, and skin dryness were noted at 4 weeks compared to baseline, but such improvements were not noted in the topical corticosteroid-only group. Subjective assessments of itching and sleep disturbance and DLQI scores also showed significant improvements in the combined-therapy group. Conclusion Combined therapy with the MLE containing Defensamide™ and PC-9S and with topical corticosteroid demonstrated superior clinical outcomes compared with topical corticosteroid monotherapy. Our findings underscore the potential of MLE-containing formulations as effective adjunctive therapies for AD, offering both objective and subjective symptomatic relief and enhancing patients' quality of life.

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