|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Johnson & Johnson Consumer & Personal Products Worldwide |
|---|---|
| Information provided by (Responsible Party): | Johnson & Johnson Consumer & Personal Products Worldwide |
| ClinicalTrials.gov Identifier: | NCT00965913 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Cessation |
Drug: Nicotine Patch Drug: Nicotine Patch Comparator Drug: Placebo Patch |
Phase I |
| 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 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 |
| Enrollment: | 42 |
| Study Start Date: | May 2005 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Three Interventions on Lower Back
Three treatments were applied on the lower back, according to treatment sequence, daily for 21 days
|
Drug: Nicotine Patch
15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days
Other Name: Experimental Nicotine Patch
Drug: Nicotine Patch Comparator
15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days
Other Name: Active Comparator Nicotine Patch
Drug: Placebo Patch
Placebo patch applied on the lower back, according to treatment sequence, daily for 21 days
Other Name: Placebo Patch Comparator
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Johnson & Johnson Consumer & Personal Products Worldwide |
| ClinicalTrials.gov Identifier: | NCT00965913 History of Changes |
| Other Study ID Numbers: | A6431082 |
| Study First Received: | August 25, 2009 |
| Last Updated: | October 4, 2011 |
| Health Authority: | Germany: Ethics Commission |
|
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 |