Topical anti-microbial peptide omiganan recovers cutaneous dysbiosis but does not improve clinical symptoms in patients with mild-to-moderate atopic dermatitis in a phase 2 randomized controlled trial

Kolk, T.N. van der; Buters, T.P.; Krouwels, L.; Boltjes, J.; Kam, M.L. de; Wall, H. van der; Alewijk, D.C.J.G. van; Munckhof, E.H.A. van den; Becker, M.J.; Feiss, G.; Florencia, E.F.; Prens, E.P.; Moerland, M.; Burggraaf, J.; Rissmann, R.; Doorn, M.B.A. van

doi:doi:10.1016/j.jaad.2020.08.132

BACKGROUND\nOBJECTIVE\nMETHODS\nRESULTS\nCONCLUSION\nDysbiosis and colonization with Staphylococcus aureus is considered to play an important role in the pathogenesis of atopic dermatitis (AD). Recovering this dysbiosis may improve AD symptoms. Omiganan is a synthetic indolicidin analogue antimicrobial peptide with activity against S. aureus and could be a viable new treatment option for AD.\nTo explore the tolerability, clinical efficacy and pharmacodynamics of omiganan in mild-to-moderate AD.\nEighty patients were randomized to omiganan 1%, 1.75%, 2.5% or vehicle twice daily for 28 days on all lesions. Weekly visits included clinical scores, and microbiological and pharmacodynamic assessments of one 'target lesion'.\nIn all omiganan treatment groups dysbiosis was recovered by reducing Staphylococcus abundance and increasing diversity. A reduction of cultured S. aureus was observed in all omiganan treatment groups, with a significant reduction for omiganan 2.5% compared to vehicle ...Show moreBACKGROUND\nOBJECTIVE\nMETHODS\nRESULTS\nCONCLUSION\nDysbiosis and colonization with Staphylococcus aureus is considered to play an important role in the pathogenesis of atopic dermatitis (AD). Recovering this dysbiosis may improve AD symptoms. Omiganan is a synthetic indolicidin analogue antimicrobial peptide with activity against S. aureus and could be a viable new treatment option for AD.\nTo explore the tolerability, clinical efficacy and pharmacodynamics of omiganan in mild-to-moderate AD.\nEighty patients were randomized to omiganan 1%, 1.75%, 2.5% or vehicle twice daily for 28 days on all lesions. Weekly visits included clinical scores, and microbiological and pharmacodynamic assessments of one 'target lesion'.\nIn all omiganan treatment groups dysbiosis was recovered by reducing Staphylococcus abundance and increasing diversity. A reduction of cultured S. aureus was observed in all omiganan treatment groups, with a significant reduction for omiganan 2.5% compared to vehicle (-93.5%, 95%CI=-99.2%/-28.5% p=0.02). No significant clinical improvement was observed.\nTopical administration of omiganan twice daily for up to 28 days in patients with mild-to-moderate AD led to a recovery of dysbiosis, but without clinical improvement. Therefore, a mono-treatment that selectively targets the microbiome does not appear to be a successful treatment strategy in mild-to-moderate AD.Show less

Leiden University Scholarly Publications

View statistics

Documents

In Collections

Topical anti-microbial peptide omiganan recovers cutaneous dysbiosis but does not improve clinical symptoms in patients with mild-to-moderate atopic dermatitis in a phase 2 randomized controlled trial