A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects
brief summary
The two products used in this study are transdermal patches that contain selegiline. The test drug is the Selegiline Transdermal Delivery System (TDS). The comparator drug is the EMSAM® TDS. The purpose of this research study is to compare how the skin tolerates the test TDS and the comparator TDS. The study will evaluate and compare skin irritation and possible allergic-type skin reactions (sensitization) caused by the two products. The comparison will be based on how the skin responds to repeated applications of each TDS. This includes the assessment of skin irritation during the Induction Period and the evaluation of possible allergic or sensitization reactions after the Challenge Period. In addition, the adhesion of each patch (how well the patch sticks to the skin over time) will be regularly checked, as this is important for both product performance and skin safety.
detailed description
This is a multi-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of Selegiline transdermal system in comparison to EMSAM® transdermal patch in healthy volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.
Trained study staff will examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales. In addition, photographs of the patch application site will be taken to document adhesion status while the patch is being worn.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced during the study.
official title
Assessment of the Irritation and Sensitization Potential of a Selegiline Transdermal Delivery System (6 mg/24 h) as Compared to a Reference Product (EMSAM® 6 mg/24 h)