Major Depressive Disorder (MDD)Phase 1NCT07452692
A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects
A Phase 1 study testing Selegiline Transdermal Delivery System in people with Major Depressive Disorder (MDD), run by Corium Innovations, Inc. at 3 sites in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Selegiline Transdermal Delivery System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 3 sitesBulgaria
- Study dates
- 23 Aug 2026to 26 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Bulgaria3 sites
MHAT Skin Systems EOOD
Elin Pelin, 2100
Diagnostic & Consultative Center "Ascendent" Ltd.
Sofia, 1202
Medical Center Neovitro
Sofia, 1404
About this study
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)
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.
Read the detailed description
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® transdermal patch in healthy 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.
Trained study staff will examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales. In addition, photographs of the patch application site will be taken to document adhesion status while the patch is being worn.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced during the study.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Selegiline Transdermal Delivery System
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selegiline Transdermal Delivery SystemDrug
1/2 Selegiline TDS patch 6 mg/24 hours and 1/2 EMSAM® patch 6 mg/24 hours will be administered simultaneously
| Study group | Role | What they receive |
|---|---|---|
| 1/2 Selegiline TDS on left arm, 1/2 EMSAM® TDS on right arm | Other | Not described Receives: Drug: Selegiline Transdermal Delivery System |
| 1/2 Selegiline TDS on right arm, 1/2 EMSAM® TDS on left arm | Other | Not described Receives: Drug: Selegiline Transdermal Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of irritation
Mean Irritation Score (MIS)
Measured: 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
Measured: From enrollment through induction, challenge and potential re-challenge phase, up to 15 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start23 Aug 2026
- Primary completion26 Sep 2026
- Study completion26 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corium Innovations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452692
- Sponsor's protocol ID
- P-25-0012
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07452692
- Acronym / sponsor ID
- P-25-0012
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Corium Innovations, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2026 (actual)
- Primary completion
- 26 Sep 2026 (actual)
- Study completion
- 26 Sep 2026 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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® transdermal patch in healthy 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.
Trained study staff will examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales. In addition, photographs of the patch application site will be taken to document adhesion status while the patch is being worn.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced during the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1/2 Selegiline TDS on left arm, 1/2 EMSAM® TDS on right arm | Other | Drug: Selegiline Transdermal Delivery System |
| 1/2 Selegiline TDS on right arm, 1/2 EMSAM® TDS on left arm | Other | Drug: Selegiline Transdermal Delivery System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selegiline Transdermal Delivery System1/2 Selegiline TDS patch 6 mg/24 hours and 1/2 EMSAM® patch 6 mg/24 hours will be administered simultaneously | Drug | 1/2 Selegiline TDS on left arm, 1/2 EMSAM® TDS on right arm, 1/2 Selegiline TDS on right arm, 1/2 EMSAM® TDS on left arm |
Primary outcome
Assessment of irritation
Time frame: From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks.
Mean Irritation Score (MIS)
Assessment of sensitization
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selegiline Transdermal Delivery System in people with Major Depressive Disorder (MDD), run by Corium Innovations, Inc. at 3 sites in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of irritation (time frame: From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.