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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Elin Pelin, Bulgaria, 2100
- MHAT Skin Systems EOOD
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Sofia, Bulgaria, 1202
- Diagnostic & Consultative Center "Ascendent" Ltd.
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Sofia, Bulgaria, 1404
- Medical Center Neovitro
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1/2 Selegiline TDS on left arm, 1/2 EMSAM® TDS on right arm
|
1/2 Selegiline TDS patch 6 mg/24 hours and 1/2 EMSAM® patch 6 mg/24 hours will be administered simultaneously
|
|
Other: 1/2 Selegiline TDS on right arm, 1/2 EMSAM® TDS on left arm
|
1/2 Selegiline TDS patch 6 mg/24 hours and 1/2 EMSAM® patch 6 mg/24 hours will be administered simultaneously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of irritation
Time Frame: From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks.
|
Mean Irritation Score (MIS)
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From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks.
|
|
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
|
From enrollment through induction, challenge and potential re-challenge phase, up to 15 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-25-0012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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