Smoking CessationPhase 1NCT00965913
Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch
A Phase 1 study testing Nicotine Patch and Nicotine Patch Comparator in people with Smoking Cessation, run by McNeil AB at 1 site in Germany.
Trial summary
An investigation on the cumulative skin irritation potential of a newly developed 15 mg nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal 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 Nicotine Patch Comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Jun 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 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
- 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
- Subjects having used nicotine products other than cigarettes within the 3 months preceding the trial or within 10 times the respective elimination half-life, whichever is longer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Cumulative Skin Irritation Potential of a Newly Developed 15 mg Nicotine Transdermal Therapeutic System. A Double Blind, Randomized, Repeat Patch Test, Single Center Study in 42 Healthy Male and Female Subjects
An investigation on the cumulative skin irritation potential of a newly developed 15 mg nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal patch.
Read the detailed description
Study on the cumulative skin irritation potential of a newly developed 15 mg nicotine transdermal therapeutic system. A double blind, randomized, repeat patch test, single center study in 42 healthy male and female subjects.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine Patch, Nicotine Patch Comparator, Placebo Patch
- 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
15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days
Nicotine Patch ComparatorDrug
Also called Active Comparator Nicotine Patch
15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days
Placebo PatchDrug
Also called Placebo Patch Comparator
Placebo patch applied on the lower back, according to treatment sequence, daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Three Interventions on Lower Back | Experimental | Three treatments were applied on the lower back, according to treatment sequence, daily for 21 days Receives: Drug: Nicotine Patch; Drug: Nicotine Patch Comparator; Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Irritation Score (CIS10)
Measured: @24 hours post- application for 21 days
Secondary outcomes (5)
Cumulative Individual Irritation Score (CIIS)
Measured: @24 hours post- application for 21 days
Frequency Indices (FI) of irritation score
Measured: @24 hours post- application for 21 days
Time to irritation reaction
Measured: @24 hours post- application for 21 days
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 posted26 Aug 2009 (estimated)
- Study startMay 2005
- Primary completionMay 2005
- Study completionJun 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, Mc Neil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965913
- Sponsor's protocol ID
- A6431082
- Other IDs
- 2005-001044-23, 012/05-03.NSI, 2005
- Status last verified
- Jun 2012
- First submitted
- 25 Aug 2009
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Cumulative Skin Irritation Potential of a Newly Developed 15 mg Nicotine Transdermal Therapeutic System. A Double Blind, Randomized, Repeat Patch Test, Single Center Study in 42 Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT00965913
- Acronym / sponsor ID
- A6431082
- Conditions
- Smoking Cessation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- May 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 26 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 investigation on the cumulative skin irritation potential of a newly developed 15 mg nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal patch.
Detailed description
Study on the cumulative skin irritation potential of a newly developed 15 mg nicotine transdermal therapeutic system. A double blind, randomized, repeat patch test, single center study in 42 healthy male and female subjects.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three Interventions on Lower Back | Experimental | Drug: Nicotine Patch, Drug: Nicotine Patch Comparator, Drug: Placebo PatchThree treatments were applied on the lower back, according to treatment sequence, daily for 21 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
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 Patch15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days | Drug | Three Interventions on Lower Back |
| Nicotine Patch ComparatorAlso: Active Comparator Nicotine Patch15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days | Drug | Three Interventions on Lower Back |
| Placebo PatchAlso: Placebo Patch ComparatorPlacebo patch applied on the lower back, according to treatment sequence, daily for 21 days | Drug | Three Interventions on Lower Back |
Primary outcome
Cumulative Irritation Score (CIS10)
Time frame: @24 hours post- application for 21 days
5 secondary outcomes
Cumulative Individual Irritation Score (CIIS)
Time frame: @24 hours post- application for 21 days
Frequency Indices (FI) of irritation score
Time frame: @24 hours post- application for 21 days
Time to irritation reaction
Time frame: @24 hours post- application for 21 days
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 29 Jun 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
Mc Neil 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 Nicotine Patch Comparator 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 7 inclusion and 19 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 29 Jun 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 Irritation Score (CIS10) (time frame: @24 hours post- application for 21 days). 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 29 Jun 2012.