Smoking CessationPhase 1NCT00966901
Photoirritation and Photoallergic Potential of a New Nicotine Patch
A Phase 1 study testing Nicotine Patch and UVA and UVB irradiation in people with Smoking Cessation, run by McNeil AB at 1 site in Germany.
Trial summary
An evaluation of the effects of UV exposure following the use of a new nicotine patch. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine Patch and UVA and UVB irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Oct 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
An evaluation of the effects of UV exposure following the use of a new nicotine patch.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine Patch, Placebo Patch, No Patch Control, UVA and UVB irradiation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
Also called Experimental 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.
Placebo PatchDrug
Also called Positive Control
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.
No Patch ControlDrug
Also called Negative Control
As a negative control, a marked site on the lower back or buttock was assigned as test area, but no patch was applied.
UVA and UVB irradiationRadiation
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| Three Treatment Sites UV Exposed | Experimental | 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) Receives: Drug: Nicotine Patch; Drug: Placebo Patch; Drug: No Patch Control; Radiation: UVA and UVB irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Individual Irritation Scores after UVA and UVB exposure
Measured: 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase.
Secondary outcomes (3)
Individual Irritation Score (IIS)
Measured: 15 min post-application, and 30 min, 24 h, 48 h, and 72 h after irradiation, depending on trial phase
Patch adhesion score
Measured: directly before patch removal
Tolerability
Measured: at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startAug 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966901
- Sponsor's protocol ID
- A6431087
- Other IDs
- 009/05-03.NPT, 2005-001641-41, 2005
- Status last verified
- Jul 2012
- First submitted
- 25 Aug 2009
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00966901
- Acronym / sponsor ID
- A6431087
- Conditions
- Smoking Cessation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An evaluation of the effects of UV exposure following the use of a new nicotine patch.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three Treatment Sites UV Exposed | Experimental | Drug: Nicotine Patch, Drug: Placebo Patch, Drug: No Patch Control, Radiation: UVA and UVB irradiationAll 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine PatchAlso: Experimental Nicotine Patch25 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. | Drug | Three Treatment Sites UV Exposed |
| Placebo PatchAlso: Positive ControlAs 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. | Drug | Three Treatment Sites UV Exposed |
| No Patch ControlAlso: Negative ControlAs a negative control, a marked site on the lower back or buttock was assigned as test area, but no patch was applied. | Drug | Three Treatment Sites UV Exposed |
| UVA and UVB irradiationAlso: IrradiationAll 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) | Radiation | Three Treatment Sites UV Exposed |
Primary outcome
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.
3 secondary outcomes
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
Patch adhesion score
Time frame: directly before patch removal
Tolerability
Time frame: at each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Kruse, PhD study director
McNeil AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotine Patch and UVA and UVB irradiation in people with Smoking Cessation, run by McNeil AB at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.