Nicotine Patch Safety Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.

Conditions
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Smokers

Intervention / Treatment
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* Drug: V0116 transdermal patch
* Drug: Nicotine transdermal patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged more than 18 years Regular smoker motivated to stop tobacco consumption Current smoker of > or = 20 cigarettes/day and < or = 25 cigarettes/day or Fagerström score > or = 5 (for smokers between 10 to 20 cigarettes/day) Exclusion Criteria: Any visible skin disorder, abnormal skin pigmentation or other dermatologic disease which, in the opinion of the investigator would interfere with the assessment of the different parameters Current or past serious chronic cardiovascular, renal, hepatic, gastrointestinal (including duodenal or gastric ulcer), endocrine, hematological, neuropsychiatric, immunosuppressive condition or allergic disease, myopathies, epileptic seizures, bleeding tendency, cancer History of angina pectoris, myocardial infarction or stroke in the previous 3 months, coronary artery vasospasm, cardiac arrhythmia, acute stroke Clinically relevant abnormal findings on the physical examination (e.g large scars on the application zone)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V0116<br>One patch per day (during 24 hours) for 21 days | Drug: V0116 transdermal patch<br>* One patch per day (during 24 hours) for 21 days<br>|
| Active Comparator: Reference<br>One patch per day (during 24 hours) for 21 days | Drug: Nicotine transdermal patch<br>* One patch per day (during 24 hours) for 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Evaluation of local safety (number of subjects with skin irritation / number of subjects by score of adhesiveness) and general safety (number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram and clinical laboratory parameters). | up to Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory profile | Visual Analogic Scales (sensations linked to patch application and removal) | Day 22 | 
| Global assessment by the patient | Visual Analog Scale Scale and questionnaires | Day 22 | 
| Subject behaviours | nicotine consumption | up to Day 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents