Cumulative Skin Irritation Potential of a New 25 mg Nicotine Patch

NCT00967174 | Completed Phase 1

• 1 other identifier: A6431083
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

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 Treatments Applied to Lower Back

EXPERIMENTAL

Treatments were applied on the lower back, according to treatment sequence, daily for 21 days.

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

Interventions

Nicotine Patch DRUG

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

Also known as: Experimental Nicotine Patch

Three Treatments Applied to Lower Back

Placebo Patch DRUG

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

Also known as: Placebo Paatch Comparator

Three Treatments Applied to Lower Back

SLS Comparator Patch DRUG

0.1% (w/v) SLS patch applied on the lower back, according to treatment sequence, daily for 21 days.

Also known as: SLS Comparator

Three Treatments Applied to 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 GmbH

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 27, 2009
• Study Start: May 1, 2005
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

DE (1)