An investigation on the cumulative skin irritation potential of a newly developed 25 mg nicotine patch. Evaluation of skin irritation of a newly developed 25 mg nicotine transdermal patch

Study on the cumulative skin irritation potential of a newly developed 25 mg nicotine transdermal therapeutic system. A double blind, randomized, repeat patch test, single center study in 42 healthy male and female subjects.

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