Clinical Trial

A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects

Not Yet Recruiting Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-01.
Trial Details
NCT Number NCT07452692
Lead Sponsor Corium Innovations, Inc.
Conditions Major Depressive Disorder (MDD)
Enrollment 230 participants
Start Date 2026-07-01
Primary Completion 2026-10-07 (estimated)
Study Completion 2026-10-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-06