Clinical trial NCT00967070: Skin Sensitization Potential of a New Nicotine Patch
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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 \[added according to Amendment No. 1\].
* 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

Primary outcomes:
measure: Cumulative Individual Irritation Scores
timeFrame: 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase
Secondary outcomes:
measure: Individual Irritation Score (IIS)
timeFrame: 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase
measure: Patch adhesion score
timeFrame: directly before patch removal
measure: Tolerability
timeFrame: at each visit
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: IKP GmbH
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References: