Healthy volunteers, occasional or regular smokers. Intended indication: Relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. MedDRA version: 9.1 Level: LLT Classification code 10057852 Term: Nicotine dependence
Conditions
Interventions
Product Name: V0116TD07AF019
Product Code: V0116TD07AF019
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: nicotine base
Conc
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - regular or occasional smokers, - aged more than 18 years, - trained in the sensory measurement of the adhesive system (use, touch and visual texture, sensation during patch application and after patch removal). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Criteria related to pathologies - serious chronic cardiovascular, renal, hepatic, gastrointestinal, endocrine, hematological, neuropsychiatric or allergic disease considered by the investigator to be incompatible with the study, - history of angina pectoris, myocardial infarction or stroke in the previous 3 months, - history of severe depression, - existence of cardiac arrhythmia, severe hypertension or cancer, - skin disease liable to interfere with use of a transdermal patch, or chronic skin disease, - history of hypersensitivity (abnormal drug reaction or idiosyncrasy) to nicotine or one of the constituents or rosin (adhesives), * Criteria related to treatments - use of nicotinic replacement therapy during the study, - use of topical products on the arm during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To document the clinical local tolerability.;Main Objective: To establish a comparative sensory profile of two new transdermal systems (V0116TD07AF019 and V0116TD07AF020) 21 mg/24h to a reference transdermal formulation NICOTINELL TTS 21 mg/24h, by describing the following characteristics : use, touch and visual texture of the patch, sensations during patch application and after patch removal.; Primary end point(s): * Rating of sensory characteristics: - Sensory touch and visual texture during patch application: easiness of use, easiness of application on the skin, visibility, surface appearance, softness, suppleness, sticky of the patch surface, thickness, adherence, - Sensations 10 minutes after patch application: burning, tension, stinging, comfort, adherence, - Sensations during patch removal: rooting up, pain, - Sensations 5 minutes after patch removal: sediment of adhesive, redness, mark of the patch, stinging, burning, sticky skin, softness. | — |
Countries
France
Outcome results
None listed