Cumulative Skin Irritation Potential of a New [amount hidden] Nicotine Patch

What Was Tested

The trial (phase 1) is built around Therapeutic nicotine (patch, non-peptide).

It had 1 arm (groups): Three Interventions on Lower Back (experimental).

Three treatments were applied on the lower back, according to treatment sequence, daily for 21 days.

The registry classes the interventions as drug.

More on the Plan

A double blind, randomized, repeat patch test, single center study in 42 healthy male and female subjects.

Who Took Part

42 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Healthy male and female subjects between 18 and 65 years. Heavy smokers (more than 10 cigarettes per day). Having had no febrile or infectious illness for at least seven days prior to the first administration of the investigational product. Women practicing one or a combination of the following methods of birth control: hormonal contraceptives, condoms, sponge, foams, jelly, diaphragm, or intrauterine device or women who are surgically sterilized. Subjects having normal skin without excessive hair growth on tested areas.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial; dermatologic disease that might interfere with the evaluation of the test site reaction; clinically relevant abnormal findings on the physical examination.

How the Study Was Run

It was run as a randomized, single-group and double-blind study.

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.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2005-05 with completion listed for 2005-05.

It ran at 1 site in Germany.

Its stated primary purpose is screening.

What Was Measured

Researchers chose this as the main measure: Cumulative Irritation Score (CIS10) (time frame: @24 hours post- application for 21 days).

It also tracked 5 secondary outcomes, for example Cumulative Individual Irritation Score (CIIS), Frequency Indices (FI) of irritation score, Time to irritation reaction, Patch adhesion score and Tolerability.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 42 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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