CClinicalTrials.gg
CompletedNCT06315946Updated Mar 18, 2024

Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.

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

From the registry’s dates

  • Registered 5 years 5 months after the study started (first participant enrolled Oct 2018, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Skin Tags
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subject
  • Sex: male or female
  • Age: between 18 and 65 years old
  • Type: Caucasion
  • Phototype: I to III according to Fitzpatrick
  • Subject presenting at least one skin tag that could be treated by the tested devices on the neck, the breast, or under armpits of 2 to 5 mm diameter.
  • Subject having given freely and expressly his/her informed consent.
  • Subject who is able to comply with the study requirements, as defined in the present CIP, at the investigator's appreciation.
  • Subject being affiliated to a health social security system.
  • Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 4 weeks before the beginning of the study and during all the study.

Exclusion criteria

Exclusion Criteria:

  • Pregnant, parturient, nursing woman or woman planning a pregnancy during the study.
  • Subject who had been deprived of their freedom by administrative or legal decision.
  • Subject who is under guardianship.
  • Subject having received 4500 euros indemnities for participation in clinical trials in the 12 previous months, including participation in the present study.
  • Subject currently participating in another research or being in an exclusion period for a previous study.
  • Subject suffering from an acute disease or any other pathology that may interfere with the evaluation of the study results at the investigator's opinion.
  • Subject with a cutaneous disease that may interfere with the evaluation of the study results or might put the subject at undue risk at the investigator's opinion.
  • Subject with a history of skin cancer.
  • Subject with a history of pre-cancerous skin lesions.
  • Subject with a known allergy to one of the component of the products, to the comparator, to nickel, to Biseptine® or any other Chlorhexidine based antiseptic or to the adhesive.
  • Subject suffering from asthma.
  • Subject who has diabetes.
  • Subject with previous event of healing disorders as hypertrophic or keloid scar, residual pigmentation etc.
  • Subject with blood circulation or blood clotting problems including Raynaud's disease; blood dyscrasias of unknown origin; haemophilia subjects.
  • Subject with immune deficiency or autoimmune disease.
  • Subject presenting birthmarks, moles, warts, or any other spots on the studied zone.
  • Subject having an inflamed, infected, irritated, red, damaged, cut, grazed, diseased or itchy skin on the treated zone.
  • Subject who already had an abnormal reaction to cold.
  • Subject whose selected skin tag is bleeding or scratched.
  • Subject undergoing a topical treatment on the test area or a systemic treatment:
  • anti-inflammatory medication during the previous 5 days and during the study,
  • immunosuppressors and/or corticoids during the 10 previous days and during the study,
  • retinoids during the 6 previous months and during the study,
  • treatment with an action on coagulation during the previous week and during the study,
  • any long-term medication stabilized for less than one month.
  • Subject who received a treatment of any type on the selected skin tag during the previous 6 months.
  • Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen exposure of the treated zone during the study.
  • Subject planning to change her/his life habits during the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Pixie® skin tag

    A skin tag is selected and treated with the test device Pixie® skin tag according to the instructions for use.

    Device: Pixie® skin tag

  • Active comparator
    Wortie® skin tag remover

    A skin tag is selected and treated with the comparator Wortie® skin tag remover.

    Device: Wortie® Skin Tag Remover

Interventions

  • DevicePixie® skin tag

    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.

  • DeviceWortie® Skin Tag Remover

    The skin tag is treated by treatment with the cryogenic device. The frozen metal nib is applied on the skin tag for 40 seconds.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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.

  4. 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)

  5. 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.

  6. 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)

07

Study locations

1 site
  • DERMSCAN - PharmScan
    Villeurbanne, 69100, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06315946
Lead sponsor
Oystershell NV
Responsible party
Sponsor
First posted
Mar 18, 2024
Start date
Oct 4, 2018
Primary completion
Jan 7, 2019
Completion
Mar 11, 2019
Last update
Mar 18, 2024

Study contacts

Emilie Bathelier, PhD
principal investigator · Dermscan/Pharmascan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion