An interventional study of Pixie® skin tag and Wortie® Skin Tag Remover in Skin Tags, sponsored by Oystershell NV. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Oystershell NV · Not applicable, Interventional, and Treatment
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 last objective of the study was to illustrate the expected visual effects.
Oystershell NV is the lead sponsor of 18 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A skin tag is selected and treated with the test device Pixie® skin tag according to the instructions for use.
Device: Pixie® skin tag
A skin tag is selected and treated with the comparator Wortie® skin tag remover.
Device: Wortie® Skin Tag Remover
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.
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
Recording of adverse events.
Time frame: Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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