Photoirritation and Photoallergic Potential of a New Nicotine Patch

What Was Tested

This registered phase 1 trial tested Therapeutic nicotine (patch, non-peptide).

An evaluation of the effects of UV exposure following the use of a new nicotine patch.

It had 1 arm (groups): Three Treatment Sites UV Exposed (experimental).

The registry classes the interventions as drug and radiation.

Who Took Part

The registry lists 43 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 males and females between 18 and 65 years. 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 and baseline score in skin reaction assessment of "0" on tested areas. Skin type I, II, or III according to Fitzpatrick.

The full record lists 9 inclusion and 18 exclusion criteria; among the exclusions: history of clinically relevant psoriasis, chronic dermatitis or urticaria; clinically relevant abnormal findings from the physical examination; pregnant (verified by beta-hcg-test in urine) and/or nursing women.

How the Study Was Run

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

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

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

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 2005-08 with completion listed for 2005-10.

It ran at 1 site in Germany.

Its stated primary purpose is screening.

What Was Measured

The main thing measured (primary outcome): Cumulative Individual Irritation Scores after UVA and UVB exposure (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 43 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.