NCT00966901

Photoirritation and Photoallergic Potential of a New Nicotine Patch

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo Patch	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.
DRUG	No Patch Control	As a negative control, a marked site on the lower back or buttock was assigned as test area, but no patch was applied.
RADIATION	UVA and UVB 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)

Timeline

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

Locations

1 site across 1 country: Germany