Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch

McNeil-PPC

Status and phase

Completed

Phase 1

Conditions

Smoking Cessation

Treatments

Drug: Nicotine Patch

Drug: Nicotine Patch Comparator

Drug: Placebo Patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT00965913

012/05-03.NSI (Other Identifier)

A6431082

2005-001044-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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