A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects
NCT07452692
Phase
Phase 1
Recruitment status
Not yet recruiting
Participants
Lead sponsor
Corium Innovations, Inc.
Start date
2026-07-01
- 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.
- Short title
- A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects
- 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)
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-10-07
- First posted
- 2026-03-05
- Registry last updated
- 2026-03-06
- Primary completion date
- 2026-10-07
- Start date
- 2026-07-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Corium Innovations, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07452692
- ClinicalTrials.gov ID
- NCT07452692
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Single group
- Purpose
- Other
- Masking
- Single masking
- Masked roles
- Outcome assessors
Sources for study design
Assessment of irritation
Timeframe: From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks.
Mean Irritation Score (MIS)
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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- 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
- 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
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Major depressive disorder Primary condition