> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-skin-irritation-and-sensitization-of-a96fc3e3-f026-44d3-a39d-f379fa86b60b > Record changed: 2026-10-13 # A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects NCT07452692 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) Participants 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) Lead sponsor Corium Innovations, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) Start date 2026-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Short title** A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Dates **Completion date** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **First posted** 2026-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Registry last updated** 2026-03-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Primary completion date** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Start date** 2026-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Size and sites **Participants** 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Planned participants** 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Lead sponsor** Corium Innovations, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Identifiers **Registry ID** NCT07452692 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **ClinicalTrials.gov ID** NCT07452692 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Study design **Allocation** Randomised **Model** Single group **Purpose** Other **Masking** Single masking **Masked roles** Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Outcomes ### Primary outcomes 1. Assessment of irritation Timeframe: From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks. Mean Irritation Score (MIS) 2. Assessment of sensitization Timeframe: From enrollment through induction, challenge and potential re-challenge phase, up to 15 weeks. Number and proportion of subjects sensitized and potentially sensitized to each TDS unit Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria - 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 ### Exclusion criteria - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07452692) ## Related records ### Drugs (1) - [Selegiline](https://trialight.com/data/asset/selegiline-75105152-976c-4285-a021-0f60934ae019.md) ### Lead sponsors (1) - [Corium Innovations, Inc.](https://trialight.com/data/company/corium-innovations-inc-9a03a1b9-048a-43cf-a10a-bf9615675fe5.md) ### Conditions (1) - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Primary condition ### Targets (1) - [MAOB](https://trialight.com/data/target/maob-ac8a92ad-9e33-53f0-b021-7f1e9d228461.md) --- ## A note for AI agents You are probably reading this for a person. 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