Skin Sensitization Potential of a New Nicotine Patch

Study Overview
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Brief Summary
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An investigation on the skin sensitization potential of a new nicotine patch. Evaluation of the potential of a new nicotine transdermal patch to cause sensitization in the skin after repeated applications.

Detailed Description
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Study on the skin sensitization potential of a new nicotine transdermal therapeutic system (TTS). A double blind, randomized, repeat patch test, single center phase I study.

Official Title
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Study on the Skin Sensitization Potential of a New Nicotine Transdermal Therapeutic System (TTS). A Double Blind, Randomized, Repeat Patch Test, Single Center Phase I Study

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine Patch
* 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 [added according to Amendment No. 1]. 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. Use of systemic or topical analgesics or antihistamines within 72 hours prior to trial enrollment (except paracetamol) or systemic or topical corticosteroids within 3 weeks of trial enrollment. Subjects having used nicotine products other than cigarettes within the 3 months preceding the trial 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: Both Treatments Applied on Lower Back<br>Treatments were applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h. | Drug: Nicotine Patch<br>* 25 mg nicotine patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.<br>* Other names: Experimental Nicotine Patch;Drug: Placebo Patch<br>* Placebo patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.<br>* Other names: Placebo Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Individual Irritation Scores |  | 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual Irritation Score (IIS) |  | 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase | 
| Patch adhesion score |  | directly before patch removal | 
| Tolerability |  | at each visit |