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

NCT07452692 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

DRUG

Selegiline Transdermal Delivery System

Selegiline Transdermal Delivery System 6 mg/24 hours and EMSAM® patch 6 mg/24 hours will be administered simultaneously

Sponsors & Collaborators

  • Corium Innovations, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-10-07
Completion
2026-10-07
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07452692 on ClinicalTrials.gov