- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00966901
Photoirritation and Photoallergic Potential of a New Nicotine Patch
July 6, 2012 updated by: McNeil AB
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.
An evaluation of the effects of UV exposure following the use of a new nicotine patch.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mannheim, Germany, 68167
- IKP GmbH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
|
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 Names:
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 Names:
As a negative control, a marked site on the lower back or buttock was assigned as test area, but no patch was applied.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patch adhesion score
Time Frame: directly before patch removal
|
directly before patch removal
|
Tolerability
Time Frame: at each visit
|
at each visit
|
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
|
15 min post-application, and 30 min, 24 h, 48 h, and 72 h after irradiation, depending on trial phase
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
August 25, 2009
First Submitted That Met QC Criteria
August 25, 2009
First Posted (Estimate)
August 27, 2009
Study Record Updates
Last Update Posted (Estimate)
July 10, 2012
Last Update Submitted That Met QC Criteria
July 6, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6431087
- 009/05-03.NPT (Other Identifier: CRO)
- 2005-001641-41 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
The University of Hong KongNot yet recruitingSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
Clinical Trials on Nicotine Patch
-
McNeil ABCompleted
-
Vanderbilt University Medical CenterCompletedDown Syndrome | Mild Cognitive ImpairmentUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedTobacco Use DisorderUnited States
-
National Institute on Drug Abuse (NIDA)CompletedSchizophrenia | Tobacco Use Disorder | Schizophrenia and Disorders With Psychotic FeaturesUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedNicotine DependenceUnited States
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)Completed
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedBreast Cancer | Colorectal Cancer | Tobacco Use Disorder | Lung Cancer | Prostate CancerUnited States
-
McNeil ABCompleted
-
Massachusetts General HospitalStanley Medical Research Institute; North Suffolk Mental Health AssociationCompleted
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)CompletedKidney Cancer | Cervical Cancer | Leukemia | Head and Neck Cancer | Gastric Cancer | Pancreatic Cancer | Esophageal Cancer | Tobacco Use Disorder | Lung Cancer | Bladder Cancer | Liver CancerUnited States