Photoirritation and Photoallergic 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:
NCT00966901
First received: August 25, 2009
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

An evaluation of the effects of UV exposure following the use of a new nicotine patch.


Condition Intervention Phase
Smoking Cessation
Drug: Nicotine Patch
Drug: Placebo Patch
Drug: No Patch Control
Radiation: UVA and UVB irradiation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Official Title: Assessment of Photoirritation and Photoallergic Potential of a Newly Developed Nicotine Transdermal Therapeutic System (TTS) After Single and Multiple Application and Multiple UV Exposure in Healthy Subjects. A Standard Photocontact Allergenicity Assay.

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 after UVA and UVB exposure [ 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 min post-application, and 30 min, 24 h, 48 h, and 72 h after irradiation, 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: 43
Study Start Date: August 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Three Treatment Sites UV Exposed
All three test sites exposed to UV radiation after patch removal. Induction: 10 J/cm2 UVA and 0.5 MED UVB, one treatment after first patch removal; and 3 MED UVB at the 5 following treatments. Challenge: 4 J/cm2 UVA and 0.5MED UVB, one treatment.( MED: Minimal Erythema Dose determined during screening)
Drug: Nicotine Patch
25 mg nicotine patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h.
Other Name: Experimental Nicotine Patch
Drug: Placebo Patch
As a positive control, a placebo patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h.
Other Name: Positive Control
Drug: No Patch Control
As a negative control, a marked site on the lower back or buttock was assigned as test area, but no patch was applied.
Other Name: Negative Control
Radiation: UVA and UVB irradiation
All three test sites exposed to UV radiation after patch removal. Induction: 10 J/cm2 UVA and 0.5 MED UVB, one treatment after first patch removal; and 3 MED UVB at the 5 following treatments. Challenge: 4 J/cm2 UVA and 0.5MED UVB, one treatment.( MED: Minimal Erythema Dose determined during screening)
Other Name: Irradiation

Detailed Description:

An evaluation on the phototoxic potential of a newly developed nicotine patch after a single dose application followed by UV exposure, and an evaluation on the photoallergenic potential of the new nicotine patch after multiple dose applications followed by UV exposure.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy males and females between 18 and 65 years.
  • Heavy smokers (more than 10 cigarettes per day) and willing to reduce the number of cigarettes smoked during the course of the study.
  • 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 and baseline score in skin reaction assessment of "0" on tested areas.
  • Skin type I, II, or III according to Fitzpatrick.
  • Evaluable MED (the lowest dose to produce mild erythema with visible borders) to UVB.
  • Evidence of a personally signed and dated informed consent document indicating that the subjects have 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, abnormal skin pigmentation, fissure or injury of the skin, which, in the opinion of the investigator, would interfere with the results of the trial.
  • History of dermatological disease or medical conditions (in particular, any immunosuppression) which could, in the opinion of the investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
  • History of clinically relevant psoriasis, chronic dermatitis or urticaria.
  • Clinically relevant abnormal findings from the physical examination.
  • Pregnant (verified by beta-HCG-test in urine) and/or nursing women.
  • Any suspicion or evidence of current alcohol or drug abuse or history of alcohol or drug abuse within the last three years.
  • Any current or past history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological (including pheochromocytoma), immunological, psychiatric or cardiovascular disease, myopathies, epileptic seizures and bleeding tendency.
  • Recent myocardial infarct (within last 3 months), unstable or deteriorating angina pectoris, coronary artery vasospasm (Prinzmetal's angina), serious cardiac arrhythmias, and acute stroke.
  • History of myopathies or epileptic seizures.
  • Use of any medication within four 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 three weeks of trial enrollment.
  • Subjects having used nicotine products other than cigarettes within the three months preceding the trial.
  • 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.
  • Subjects who cannot avoid, throughout the duration of the trial, any swimming, any washing of the lower back (i.e., the areas which to be patched and/or irradiated during this study), usage of sauna or any intense physical activity that might result in excessive sweating.
  • Any history of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever.
  • Known sensitivity to adhesive tape.
  • Known sensitivity to any component of the test products.
  • History of irritation to topically applied products.
  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: NCT00966901

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: NCT00966901     History of Changes
Other Study ID Numbers: A6431087, 009/05-03.NPT, 2005-001641-41
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 22, 2014