Pharmacodynamic Effects of Topical Omiganan in Patients With Mild to Moderate Atopic Dermatitis in a Randomized, Placebo-Controlled, Phase II Trial.

Autor: Niemeyer-van der Kolk T; Centre for Human Drug Research, Leiden, The Netherlands.; Leiden University Medical Center, Leiden, The Netherlands., van der Wall H; Centre for Human Drug Research, Leiden, The Netherlands.; Leiden Academic Center for Drug Research, Leiden, The Netherlands., Hogendoorn GK; Centre for Human Drug Research, Leiden, The Netherlands., Rijneveld R; Centre for Human Drug Research, Leiden, The Netherlands., Luijten S; Centre for Human Drug Research, Leiden, The Netherlands., van Alewijk DCJG; DDL Diagnostic Laboratory, Rijswijk, The Netherlands., van den Munckhof EHA; DDL Diagnostic Laboratory, Rijswijk, The Netherlands., de Kam ML; Centre for Human Drug Research, Leiden, The Netherlands., Feiss GL; Cutanea Life Sciences, Wayne, Pennsylvania, USA., Prens EP; Department of Dermatology, Erasmus Medical Centre, Rotterdam, The Netherlands., Burggraaf J; Centre for Human Drug Research, Leiden, The Netherlands.; Leiden University Medical Center, Leiden, The Netherlands.; Leiden Academic Center for Drug Research, Leiden, The Netherlands., Rissmann R; Centre for Human Drug Research, Leiden, The Netherlands.; Leiden University Medical Center, Leiden, The Netherlands.; Leiden Academic Center for Drug Research, Leiden, The Netherlands., van Doorn MBA; Centre for Human Drug Research, Leiden, The Netherlands.; Department of Dermatology, Erasmus Medical Centre, Rotterdam, The Netherlands.
Jazyk: angličtina
Zdroj: Clinical and translational science [Clin Transl Sci] 2020 Sep; Vol. 13 (5), pp. 994-1003. Date of Electronic Publication: 2020 May 01.
DOI: 10.1111/cts.12792
Abstrakt: Omiganan is an indolicidin analog with antimicrobial properties that could be beneficial for patients with atopic dermatitis. In this randomized, double-blind, placebo-controlled, phase II trial we explored the efficacy, pharmacodynamics, and safety of topical omiganan once daily in 36 patients with mild to moderate atomic dermatitis. Patients were randomized to apply topical omiganan 1%, omiganan 2.5%, or vehicle gel to one target lesion once daily for 28 consecutive days. Small but significant improvements in local objective SCORing Atopic Dematitis index and morning itch were observed in the omiganan 2.5% group compared with the vehicle gel group (-18.5%; 95% confidence interval, -32.9 to -1.0; P = 0.04; and -8.2; 95% confidence interval, -16.3 to -0.2; P = 0.05, respectively). A shift from lesional to nonlesional skin microbiota was observed in both omiganan treatment groups, in contrast to the vehicle group. Thus, treatment with topical omiganan improved dysbiosis in patients with mild to moderate atopic dermatitis, and small but statistically significant improvements in clinical scores were detected. Our findings warrant further exploration in future clinical trials.
(© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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