Nicotine Patch Safety Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01655082

Enrollment

160

Registered

2012-08-01

Start date

2012-08-31

Completion date

2012-10-31

Last updated

2012-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smokers

Keywords

Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents

Brief summary

The purpose of this study is to evaluate the safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.

Interventions

DRUGNicotine transdermal patch

One patch per day (during 24 hours) for 21 days

DRUGV0116 transdermal patch

One patch per day (during 24 hours) for 21 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female aged more than 18 years * Regular smoker motivated to stop tobacco consumption * Current smoker of \> or = 20 cigarettes/day and \< or = 25 cigarettes/day or Fagerström score \> or = 5 (for smokers between 10 to 20 cigarettes/day)

Exclusion criteria

* Any visible skin disorder, abnormal skin pigmentation or other dermatologic disease which, in the opinion of the investigator would interfere with the assessment of the different parameters * Current or past serious chronic cardiovascular, renal, hepatic, gastrointestinal (including duodenal or gastric ulcer), endocrine, hematological, neuropsychiatric, immunosuppressive condition or allergic disease, myopathies, epileptic seizures, bleeding tendency, cancer * History of angina pectoris, myocardial infarction or stroke in the previous 3 months, coronary artery vasospasm, cardiac arrhythmia, acute stroke * Clinically relevant abnormal findings on the physical examination (e.g large scars on the application zone)

Design outcomes

Primary

Measure	Time frame	Description
Safety	up to Day 22	Evaluation of local safety (number of subjects with skin irritation / number of subjects by score of adhesiveness) and general safety (number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram and clinical laboratory parameters).

Secondary

Measure	Time frame	Description
Sensory profile	Day 22	Visual Analogic Scales (sensations linked to patch application and removal)
Global assessment by the patient	Day 22	Visual Analog Scale Scale and questionnaires
Subject behaviours	up to Day 22	nicotine consumption

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026