NCT00967174

Cumulative Skin Irritation Potential of a New 25 mg Nicotine Patch

Study on the Cumulative Skin Irritation Potential of a Newly Developed 25 mg Nicotine Transdermal Therapeutic System. A Double Blind, Randomized, Repeat Patch Test, Single Center Study in 42 Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

An investigation on the cumulative skin irritation potential of a newly developed 25 mg nicotine patch. Evaluation of skin irritation of a newly developed 25 mg nicotine transdermal patch

Detailed description

Study on the cumulative skin irritation potential of a newly developed 25 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

Interventions

Type	Name	Description
DRUG	Nicotine Patch	25 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days.
DRUG	Placebo Patch	Placebo Patch applied on the lower back, according to treatment sequence, daily for 21 days.
DRUG	SLS Comparator Patch	0.1% (w/v) SLS patch applied on the lower back, according to treatment sequence, daily for 21 days.

Timeline

• Start date: 2005-05-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2009-08-27
• Last updated: 2012-07-10

Locations

1 site across 1 country: Germany