A clinical trial supported by Galderma is to be conducted at UCSD to determine via changes in inflammatory markers, how Ivermectin works to relieve rosacea symptoms.
After 12 weeks participants will be examined to determine changes in serine protease activity and expression of cathelicidin (LL-37) mRNA. Any changes found in these inflammatory markers will be correlated with changes in rosacea severity.
It seems that Galderma is wanting to address how Soolantra actually works, as its method of success in rosacea is not clear. This trial will reveal how Soolantra operates at least in as far as these inflammatory markers are concerned.
Clinical Trial NCT02806414
A Single Site Evaluation of the Inhibitory Effects of Topical Ivermectin on Serine Protease Activity and Production of LL-37 Cathelicidin Peptide, Biochemical Markers of Rosacea-specific Inflammation.Sponsor: University of California, San DiegoCollaborator: Galderma
This study will assess the role of topical Ivermectin 1% cream and its effect on protease and antimicrobial peptide expression in rosacea.
This is a single-site 16-week open label study at University of California, San Diego. We will do this by first measuring serine protease activity and cathelicidin of all subjects.
All subjects will receive Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks. Participants will return for monthly visits during which their clinical symptoms of facial redness and number of facial papules will be scored, and they will have repeat tape stripping.
At the end of the study, tape strips will be analyzed to determine serine protease activity of participants at each of their visits and expression of cathelicidin (LL-37) mRNA. We will then look at changes in serine protease activity and LL-37 expression over time, and we will also determine whether or not these changes correlate with disease severity.
Primary Outcome Measures: The change in biochemical markers of rosacea-specific inflammation, such as LL-37 and KLK5, after 12 weeks of topical ivermectin.
Secondary Outcome Measures: The correlation between the change in clinical rosacea assessments after 12 weeks of topical ivermectin application and the change in LL-37 and KLK5.
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