Skin Sensitization Potential of a New Nicotine Patch

NCT00967070 | Completed Phase 1

• 1 other identifier: A6431084
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Cumulative Individual Irritation Scores

  15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase

Secondary Outcomes (3)

• Individual Irritation Score (IIS)

  15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase

• Patch adhesion score

  directly before patch removal

• Tolerability

  at each visit

Study Arms (1)

Both Treatments Applied on Lower Back

EXPERIMENTAL

Treatments were applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.

Drug: Nicotine Patch; Drug: Placebo Patch

Interventions

Nicotine Patch DRUG

25 mg nicotine patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.

Also known as: Experimental Nicotine Patch

Both Treatments Applied on Lower Back

Placebo Patch DRUG

Placebo patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.

Also known as: Placebo Control

Both Treatments Applied 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 \[added according to Amendment No. 1\].
• 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

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

  McNeil 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: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

DE (1)