Skin TagsNCT06315946
Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.
A study testing Pixie® skin tag and Wortie® Skin Tag Remover in people with Skin Tags, run by Oystershell NV at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Tags
- What is being tested?
- Pixie® skin tag and Wortie® Skin Tag Remover
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2018to 11 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.
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.
- Conditions
- Skin Tags
- Being tested
- Pixie® skin tag, Wortie® Skin Tag Remover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pixie® skin tagDevice
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.
Wortie® Skin Tag RemoverDevice
The skin tag is treated by treatment with the cryogenic device. The frozen metal nib is applied on the skin tag for 40 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Pixie® skin tag | Experimental | A skin tag is selected and treated with the test device Pixie® skin tag according to the instructions for use. Receives: Device: Pixie® skin tag |
| Wortie® skin tag remover | Active comparator | A skin tag is selected and treated with the comparator Wortie® skin tag remover. Receives: Device: Wortie® Skin Tag Remover |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 45 +-2 days
Secondary outcomes (6)
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.
Measured: day 45 +-2 days
Visual aspect
Evaluation of devices efficacy by subjects' self-assessment, using a subjective evaluation questionnaire completed at the study end.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start4 Oct 2018
- Primary completion7 Jan 2019
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TagsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilie Bathelier, PhD, Principal investigator, Dermscan/Pharmascan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315946
- Sponsor's protocol ID
- 17E3241
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.
- ClinicalTrials.gov ID
- NCT06315946
- Acronym / sponsor ID
- 17E3241
- Conditions
- Skin Tags
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pixie® skin tag | Experimental | Device: Pixie® skin tagA skin tag is selected and treated with the test device Pixie® skin tag according to the instructions for use. |
| Wortie® skin tag remover | Active comparator | Device: Wortie® Skin Tag RemoverA skin tag is selected and treated with the comparator Wortie® skin tag remover. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy subject
- Sex: male or female
- Age: between 18 and 65 years old
- Type: Caucasion
- Phototype: I to III according to Fitzpatrick
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pixie® skin tagThe 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. | Device | Pixie® skin tag |
| Wortie® Skin Tag RemoverThe skin tag is treated by treatment with the cryogenic device. The frozen metal nib is applied on the skin tag for 40 seconds. | Device | Wortie® skin tag remover |
Primary outcome
Percentage of subjects with successful treatment
Time frame: day 45 +-2 days
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.
6 secondary outcomes
Number of treatments
Time frame: day 45 +-2 days
Visual aspect
Time frame: Every day (for a period of 45 days +- 2 days)
Macrophotographs on skin tag remission
Time frame: Day 0 (before treatment); day 15 (before treatment); day 30 (before treatment) and day 45 if applicable.
Evaluation of the skin condition
Time frame: Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)
Degree of pain
Time frame: During treatement on day 0, and if applicable on follow-up treatments on day 15 and day 30.
Recording of adverse events
Time frame: Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Bathelier, PhD principal investigator
Dermscan/Pharmascan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pixie® skin tag and Wortie® Skin Tag Remover in people with Skin Tags, run by Oystershell NV at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with successful treatment (time frame: day 45 +-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.