Skin Sensitization Potential of a New Nicotine Patch

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT00967070
First received: August 25, 2009
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: Nicotine Patch
Drug: Placebo Patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Cumulative Individual Irritation Scores [ Time Frame: 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual Irritation Score (IIS) [ Time Frame: 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase ] [ Designated as safety issue: No ]
  • Patch adhesion score [ Time Frame: directly before patch removal ] [ Designated as safety issue: No ]
  • Tolerability [ Time Frame: at each visit ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: May 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Both Treatments Applied on Lower Back
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
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.
Other Name: Experimental Nicotine Patch
Drug: Placebo Patch
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.
Other Name: Placebo Control

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967070

Locations
Germany
IKP GmbH
Mannheim, Germany, 68167
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT00967070     History of Changes
Other Study ID Numbers: A6431084
Study First Received: August 25, 2009
Last Updated: July 6, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014