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

Starting soon · Phase 1

Conditions studied: Major Depressive Disorder (MDD)

In brief

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.

Key facts

Study ID

NCT07452692

Run by

Corium Innovations, Inc.

People needed

230

Starts

2026-07-01

Expected to finish

2026-10-07

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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

Full record on ClinicalTrials.gov

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