Skin Sensitization Potential of a New Nicotine Patch

What Was Tested

In this phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide) for skin sensitivity and body aches on glp-1 medicines.

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.

It had 1 arm (groups): Both Treatments Applied on Lower Back (experimental).

Treatments were 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.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 257 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 20 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

Design: randomized, single-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Blinding on both sides kept the skin sensitivity and body aches on glp-1 medicines participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

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 2005-08.

It ran at 1 site in Germany.

Its stated primary purpose is screening.

What Was Measured

Primary outcome: Cumulative Individual Irritation Scores (time frame: 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase).

It also tracked 3 secondary outcomes, for example Individual Irritation Score (IIS), 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 257 people with skin sensitivity and body aches on glp-1 medicines.

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, Skin sensitivity and body aches on GLP-1 medicines research.