Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch

Study Overview
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Brief Summary
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An investigation on the cumulative skin irritation potential of a newly developed 15 mg nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal patch.

Detailed Description
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Study on the cumulative skin irritation potential of a newly developed 15 mg nicotine transdermal therapeutic system. A double blind, randomized, repeat patch test, single center study in 42 healthy male and female subjects.

Official Title
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Study on the Cumulative Skin Irritation Potential of a Newly Developed 15 mg Nicotine Transdermal Therapeutic System. A Double Blind, Randomized, Repeat Patch Test, Single Center Study in 42 Healthy Male and Female Subjects

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine Patch
* Drug: Nicotine Patch Comparator
* Drug: Placebo Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects between 18 and 65 years Heavy smokers (more than 10 cigarettes per day) Having had no febrile or infectious illness for at least seven days prior to the first administration of the investigational product. Women practicing one or a combination of the following methods of birth control: hormonal contraceptives, condoms, sponge, foams, jelly, diaphragm, or intrauterine device or women who are surgically sterilized. Subjects having normal skin without excessive hair growth on tested areas. Evidence of a personally signed and dated informed consent document indicating that the subjects has been informed of all pertinent aspects of the trial. Subjects who are willing to comply with scheduled visits, treatment plan and other trial procedures. Exclusion Criteria: Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial Dermatologic disease that might interfere with the evaluation of the test site reaction History of chronic, dermatological, medical, or physical conditions which would, in the opinion of the investigator, preclude topical application of the test products and/or influence the outcome of the test (in particular, any immunosuppressive condition) Clinically relevant abnormal findings on the physical examination A baseline score in skin reaction assessments other than 0 on the areas to be patched Pregnant (verified by beta-hCG-test in urine) and/or nursing women Demonstrating any active physical disease, acute or chronic Any suspicion, history or evidence of alcohol or drug abuse Any history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis as well as current hay fever Any current or past history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, epileptic seizures and bleeding tendency Recent myocardial infarct (within the last 3 months), unstable or deteriorating angina pectoris, coronary artery vasospasm (Prinzmetal's angina), serious cardiac arrythmias and acute stroke Use of any medication within 4 weeks prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects Subjects having used nicotine products other than cigarettes within the 3 months preceding the trial or within 10 times the respective elimination half-life, whichever is longer Subjects who cannot avoid, throughout the duration of the trial, any swimming, any washing of the back and sauna or any intense physical activity that might result in excessive sweating Known sensitivity to adhesive tape Known sensitivity to any component of the test products History of irritation to topically applied products Fissure or injury of the skin at the test area Participation in the treatment phase of a clinical trial within 30 days prior to the treatment phase of this trial or within 10 times the respective elimination half-life of the investigational drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three Interventions on Lower Back<br>Three treatments were applied on the lower back, according to treatment sequence, daily for 21 days | Drug: Nicotine Patch<br>* 15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days<br>* Other names: Experimental Nicotine Patch;Drug: Nicotine Patch Comparator<br>* 15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days<br>* Other names: Active Comparator Nicotine Patch;Drug: Placebo Patch<br>* Placebo patch applied on the lower back, according to treatment sequence, daily for 21 days<br>* Other names: Placebo Patch Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Irritation Score (CIS10) |  | @24 hours post- application for 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Individual Irritation Score (CIIS) |  | @24 hours post- application for 21 days | 
| Frequency Indices (FI) of irritation score |  | @24 hours post- application for 21 days | 
| Time to irritation reaction |  | @24 hours post- application for 21 days | 
| Patch adhesion score |  | directly before patch removal | 
| Tolerability |  | at each visit |