Evaluate the efficacy of the test medical device (Pixie® skin tag) in the treatment of skin tags versus a comparator product (Wortie® skin tag remover).
The main objective of the study was to evaluate the efficacy of the test medical device Pixie® skin tag) in the treatment of skin tags versus a comparator product (Wortie® skin tag remover). Non-inferiority of the test product versus competitor on skin tag evaluated by clinical evaluation. The secondary objectives of the study were to evaluate: * the number of treatments needed for the complete disappearance of skin tag; * the efficacy of devices by subjects' self-assessment; * the cutaneous tolerability (safety). The last objective of the study was to illustrate the expected visual effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
The skin tag is treated by treatment with the cryogenic device. To protect the surrounding skin, a protective foam plaster is applied before the device is used on the skin tag. The skin tag is treated for 20 seconds after loading the device for 2 seconds.
The skin tag is treated by treatment with the cryogenic device. The frozen metal nib is applied on the skin tag for 40 seconds.
DERMSCAN - PharmScan
Villeurbanne, France
Percentage of subjects with successful treatment
Comparison of the percentage of subjects having a successful treatment of their skin tag in the test group versus the comparator; clinical evaluation by a blinded evaluator.
Time frame: day 45 +-2 days
Number of treatments
Comparison of the number of treatments needed for clinical remission of the skin tag with both products, as assessed by the blinded evaluator.
Time frame: day 45 +-2 days
Visual aspect
Evaluation of devices efficacy by subjects' self-assessment, using a subjective evaluation questionnaire completed at the study end.
Time frame: Every day (for a period of 45 days +- 2 days)
Macrophotographs on skin tag remission
Illustration of the visual aspects of the process of skin tag remission by realisation of macrophotographs.
Time frame: Day 0 (before treatment); day 15 (before treatment); day 30 (before treatment) and day 45 if applicable.
Evaluation of the skin condition
Evaluation of the skin conditions to assess products tolerability at each timepoint, assessed by the investigator by clinical evaluation.
Time frame: Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)
Degree of pain
Evaluation of the degree of pain felt by subjects during the treatment.
Time frame: During treatement on day 0, and if applicable on follow-up treatments on day 15 and day 30.
Recording of adverse events
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Recording of adverse events.
Time frame: Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)