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

NCT07452692 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: P-25-0012
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (2)

• Assessment of irritation

  Mean Irritation Score (MIS)

  From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks.

• Assessment of sensitization

  Number and proportion of subjects sensitized and potentially sensitized to each TDS unit

  From enrollment through induction, challenge and potential re-challenge phase, up to 15 weeks.

Study Arms (2)

Selegiline TDS on left arm, EMSAM® TDS on right arm

OTHER

Drug: Selegiline Transdermal Delivery System

Selegiline TDS on right arm, EMSAM® TDS on left arm

OTHER

Drug: Selegiline Transdermal Delivery System

Interventions

Selegiline Transdermal Delivery System DRUG

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

Selegiline TDS on left arm, EMSAM® TDS on right arm; Selegiline TDS on right arm, EMSAM® TDS on left arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female non-smoking subject.
• Lack of clinically significant abnormalities in health assessments performed at screening as deemed by the Investigator (or designee)
• BMI within the range (including the borders) of 18.5 to 29.9 kg/m2

You may not qualify if:

• Medical history or presence of ANY current dermatological condition such as atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, or urticaria which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of the study
• Medical history or current evidence, as determined by the Investigator, of chronic infectious disease, system disorders, seizure disorders, or cardiovascular disorders (especially hypertension or family history of sudden cardiac death)
• Medical history of a condition that would significantly influence the immune response (e.g., primary or acquired immunodeficiencies such as HIV or AIDS; allergic diseases such as anaphylaxis, asthma, or generalized drug reaction; neoplasms such as lymphoma or leukemia; rheumatoid arthritis; or systemic lupus erythematosus)
• Clinically significant illness within 4 weeks before screening visit

Sponsors & Collaborators

• Corium Innovations, Inc.: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Ann Vollmer

CONTACT

(616) 656-4563; clinicaltrials@coriumintl.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 patch in healthy adult 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.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 7, 2026
• Study Completion (Estimated): October 7, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03