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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
One patch per day (during 24 hours) for 21 days
One patch per day (during 24 hours) for 21 days
Unnamed facility
Gières, France
Unnamed facility
Pierre-Bénite, France
Unnamed facility
Rennes, France
Unnamed facility
Rueil-Malmaison, France
Safety
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).
Time frame: up to Day 22
Sensory profile
Visual Analogic Scales (sensations linked to patch application and removal)
Time frame: Day 22
Global assessment by the patient
Visual Analog Scale Scale and questionnaires
Time frame: Day 22
Subject behaviours
nicotine consumption
Time frame: up to Day 22
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