Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch

NCT00965913 | Completed Phase 1

• 3 other identifiers: A64310822005-001044-23012/05-03.NSI
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Cumulative Irritation Score (CIS10)

  @24 hours post- application for 21 days

Secondary Outcomes (5)

• 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

Study Arms (1)

Three Interventions on Lower Back

EXPERIMENTAL

Three treatments were applied on the lower back, according to treatment sequence, daily for 21 days

Drug: Nicotine Patch; Drug: Nicotine Patch Comparator; Drug: Placebo Patch

Interventions

Nicotine Patch DRUG

15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days

Also known as: Experimental Nicotine Patch

Three Interventions on Lower Back

Nicotine Patch Comparator DRUG

15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days

Also known as: Active Comparator Nicotine Patch

Three Interventions on Lower Back

Placebo Patch DRUG

Placebo patch applied on the lower back, according to treatment sequence, daily for 21 days

Also known as: Placebo Patch Comparator

Three Interventions on Lower Back

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

IKP

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Elisabeth Kruse, PhD

  Mc Neil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2009
• First Posted: August 26, 2009
• Study Start: May 1, 2005
• Primary Completion: May 1, 2005
• Study Completion: June 1, 2005
• Last Updated: June 29, 2012

Record last verified: 2012-06

Locations

DE (1)