NCT00967070

Skin Sensitization Potential of a New Nicotine Patch

Study on the Skin Sensitization Potential of a New Nicotine Transdermal Therapeutic System (TTS). A Double Blind, Randomized, Repeat Patch Test, Single Center Phase I Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

An investigation on the skin sensitization potential of a new nicotine patch. Evaluation of the potential of a new nicotine transdermal patch to cause sensitization in the skin after repeated applications.

Detailed description

Study on the skin sensitization potential of a new nicotine transdermal therapeutic system (TTS). A double blind, randomized, repeat patch test, single center phase I study.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotine Patch	25 mg nicotine patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.
DRUG	Placebo Patch	Placebo patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.

Timeline

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

Locations

1 site across 1 country: Germany