Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00965913
• Date of registration: 25/08/2009
• Primary sponsor: McNeil AB
• Public title: Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch
• Scientific title: 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
• Date of first enrolment: May 2005
• Target sample size: 42
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00965913
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Countries of recruitment

Germany

Contacts

• Name: Elisabeth Kruse, PhD
• Affiliation: Mc Neil AB

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Smoking Cessation

Intervention(s)

Drug: Nicotine Patch

Drug: Nicotine Patch Comparator

Drug: Placebo Patch

Primary Outcome(s)

Cumulative Irritation Score (CIS10) [Time Frame: @24 hours post- application for 21 days]

Secondary Outcome(s)

Cumulative Individual Irritation Score (CIIS) [Time Frame: @24 hours post- application for 21 days]

Frequency Indices (FI) of irritation score [Time Frame: @24 hours post- application for 21 days]

Patch adhesion score [Time Frame: directly before patch removal]

Time to irritation reaction [Time Frame: @24 hours post- application for 21 days]

Tolerability [Time Frame: at each visit]

Secondary ID(s)

012/05-03.NSI

2005-001044-23

A6431082

Source(s) of Monetary Support

Please refer to primary and secondary sponsors