Smoking Cessation
Conditions
Brief summary
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
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.
Interventions
DRUGNicotine Patch
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.
DRUGPlacebo Patch
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.
Sponsors
McNeil AB
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative Individual Irritation Scores | 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed