Clinical evaluation of the contact sensitization potential of a transdermal nicotine system (Nicoderm)

What Was Tested

Researchers studied Therapeutic nicotine (patch, non-peptide) in this randomized controlled trial publication.

Who Took Part

The age groups tagged for this paper are teenagers, adults, middle-aged adults and older adults, both men and women.

During phase 1, a 42-day open-label induction period, subjects wore only active transdermal nicotine systems.

During phase 2, a 4-day double-blind challenge period, subjects wore active and placebo systems concurrently.

How the Study Was Run

The design is described as randomized, double-blind, open-label and placebo-controlled.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The comparison arm used a placebo, so changes seen with Therapeutic nicotine (patch, non-peptide) could be set against what happens without it.

This study comprised two phases separated by a 2-week rest interval.

Upon removal of each patch, skin sites were evaluated for signs of irritation, and subjective complaints such as itching or burning were recorded.

What Was Measured

Topics PubMed links to this paper include Adhesives, Administration, Cutaneous, Dermatitis, Contact, Nicotine and Smoking.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Therapeutic nicotine (patch, non-peptide).

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 1992 (The Journal of family practice), a journal based in United States.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.