Finding studies
Finding studies
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Lead
Rubedo Life Sciences, Inc.
This open-label study is designed to assess the safety, tolerability, and clinical effects, and pharmacodynamic effects of topically applied RLS-1496 1.0% cream for the treatment of AK lesions and perilesional skin on the left dorsal forearm of adults. The right dorsal forearm will remain untreated as a control. Eligible patients will apply study drug under the supervision of the study staff to the designated affected area on the left dorsal forearm on Day 1 and will be instructed to apply at home starting on Day 2 and each evening thereafter for a total of 28 applications. Patients will be followed for up to 3 months after the last application of study drug. Safety evaluations will include treatment-emergent adverse events (TEAEs), physical examinations, vital signs, local tolerability assessments, and clinical laboratory assessments. Clinical assessments of treatment effect will be evaluated at each designated treatment and control area. Local tolerability will be assessed. The Investigator will count discrete AK lesions within the designated treatment and control areas. Additional assessments will include selected disease-specific biomarkers and markers for target engagement, and senescence in the skin (biopsy and tape stripping), and in the blood. Following a screening period of up to 28 days, eligible participants will be dosed through Day 28 and followed for an additional 84 days. Approximately 24 patients will be enrolled in the study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
