Smoking Cessation
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGNicotine Patch
25 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days.
DRUGPlacebo Patch
Placebo Patch applied on the lower back, according to treatment sequence, daily for 21 days.
DRUGSLS Comparator Patch
0.1% (w/v) SLS patch applied on the lower back, according to treatment sequence, daily for 21 days.
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative Irritation Score (CIS10) | @24 hours post- application for 21 days |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed