NCT07452692CompletedPhase 1
A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects
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 · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 232 (actual)
- First submitted
- 25 Feb 2026
- Start date
- 23 Aug 2026
- Primary completion date
- 26 Sept 2026
- Lead sponsor
- Corium Innovations, Inc.
- Diseases
- Depression
- NCT number
- NCT07452692
- EU CT number
- 2026-525269-34-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 232
- From 23 Aug 2026 to the primary completion date, 26 Sept 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant illness within 4 weeks before screening visit
Other illness
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MHAT Skin Systems EOOD Coordinator of this site? Confirm its status | Elin Pelin | Bulgaria | Active, not recruiting |
| MC Neovitro OOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Acibadem City Clinic EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Diagnostic Consultative Centre Ascendent EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.