Skin TagsNCT07355543
Evaluate the Effectiveness and Safety of a Cryogenic Pen to Treat Skin Tags Versus a Comparator.
A study testing NITROFREEZE Skin tag and Scholl Freeze Away Skin Tag Remover in people with Skin Tags, run by Oystershell NV at 1 site in France.
Trial summary
The purpose of this clinical investigation is to evaluate the effectiveness and safety of Nitrofreeze Skin Tag for the treatment of skin tags versus a comparator device (Scholl Freeze Away® Skin Tag Remover). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Skin Tags
- What is being tested?
- NITROFREEZE Skin tag and Scholl Freeze Away 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
- 6 Oct 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy subject.
- Sex: male or female.
- Age: more than 22 years old.
- Phototype: I to III according to Fitzpatrick.
- Subject presenting at least one skin tag that could be treated by the tested devices as evaluated by the investigator:
- Location: on the neck, chest, back, groin or underarm;
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- Colour: skin tags must be similar in colour to the surrounding skin;
- Shape \& Feel: skin tags must be soft and flexible.
- Size: 2 to 5 mm in size.
- 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 affiliated to a health social security system.
- Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during all the study.
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
- Subject enrolled in another clinical trial or which exclusion period is not over.
- Member of the CRO or the centre staff.
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- Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
- Subject suffering from a severe or progressive disease (including asthma and diabetes).
- Subject with immune deficiency or autoimmune disease.
- Subject suffering from an acute or cutaneous disease or any other cutaneous pathology.
- Subject with a history of skin cancer or pre-cancerous skin lesions.
- Subject with previous event of healing disorders such 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 presenting skin growths such as birthmarks, moles, warts, or any other unusual-looking skin condition on the treated zone.
- Subject having thin, inflamed, damaged, irritated, itchy, infected, cut, grazed, diseased or red skin on and around the treated zone.
- Subject with molluscum contagiosum, blisters or any other vesicles on the skin on and around the treated zone.
- Subject with a known allergy to Chlorhexidine based antiseptic or to adhesives.
- Subject who already had an abnormal reaction to cold.
- Subject whose selected skin tag is bleeding or scratched.
- Subject whose skin tag is located on the face, scalp or mucosa, anus, genitals, buttocks, lips, eyelids or eyes.
- Subject undergoing a topical treatment on the test area or a systemic treatment:
- anti-inflammatory medication within 5 days prior to D0 visit,
- immunosuppressors and/or corticoids within 10 days prior to D0 visit,
- retinoids within 6 months prior to D0 visit,
- treatment with an action on coagulation within 1 week prior to D0 visit,
- any long-term medication stabilized for less than one month.
- Subject who received a treatment of any kind on the selected skin tag within 6 months prior to D0 visit.
- Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen exposure of the treated zone during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Eurofins Dermscan Pharmascan
Villeurbanne, 69100
Florence REBER, +33(0)4 72 89 36 56, Florence.Reber@cpt.eurofinseu.com
About this study
Official title: Prospective, Single Centre, Single-blinded, Randomized Clinical Investigation to Evaluate the Effectiveness and Safety of a Cryogenic Device to Treat Skin Tags Versus a Comparator Product.
The purpose of this clinical investigation is to evaluate the effectiveness and safety of Nitrofreeze Skin Tag for the treatment of skin tags versus a comparator device (Scholl Freeze Away® Skin Tag Remover).
Read the detailed description
The primary objective of the study is to assess the efficacy of Nitrofreeze Skin Tag (tested product) for the treatment of skin tags versus a comparator product.
The secondary objectives are to assess the safety of the tested product versus comparator product.
To meet these objectives, the subjects will be monitored as follows:
At the screening visit (visit 1), the study will be explained to the subject by the investigator before any study related procedures are performed. Both the subject and the investigator will sign the consent form and the investigator will check inclusion and exclusion criteria. This can also be done at the D0 visit.
At visit 2 on D0, if the subject is eligible, the subject will perform the first treatment on the selected skin tag with the tested product or comparator, at the lab.
At visit 3 on D3, the investigator will evaluate the skin condition on and around the skin tag and collect adverse events.
At visit 4 on D15, assessment of effectiveness and safety will be made. A second treatment can be done if first treatment is not effective. Study end if the skin tag was successfully removed.
At visit 5 on D30, assessment of effectiveness and safety will be made. A third treatment can be done if second treatment is not effective. Study end if the skin tag was successfully removed.
At visit 6 on D45, assessment of effectiveness and safety will be made. Study end.
In case of missing treatment on D15 or D30 because of a missing visit or a skin condition that did not permit a new treatment, the third treatment will be done on D45. In that case, a new follow-up visit will be done at D60.
- Conditions
- Skin Tags
- Being tested
- NITROFREEZE Skin tag, Scholl Freeze Away Skin Tag Remover
- Keywords
- NITROFREEZE SKIN TAG, SKIN TAG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NITROFREEZE Skin tagDevice
Treatment of the skin tag with NITROFREEZE Skin Tag device on Day 0, Day 15, Day 30.
Scholl Freeze Away Skin Tag RemoverDevice
Treatment of the skin tag with Scholl Freeze Away Skin Tag Remover device on Day 0, Day 15, Day 30.
| Study group | Role | What they receive |
|---|---|---|
| NITROFREEZE SKIN TAG | Experimental | Topical application on the selected skin tag for 20 seconds. Maximum of 3 treatments with a 15 days interval between each treatment. Receives: Device: NITROFREEZE Skin tag |
| Scholl Freeze Away Skin Tag Remover | Active comparator | Topical application on the selected skin tag for 40 seconds. Skin tag can be removed in 1 treatment. If the skin tag has not fallen off in 2 weeks, you may treat the skin tag again, up to 3 treatment cycles. Receives: Device: Scholl Freeze Away Skin Tag Remover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Comparison of the percentage of subjects having a successful treatment of the selected skin tag in the Nitrofreeze Skin Tag group versus comparator group by clinical evaluation by the blinded evaluator.
The investigator, who will be in blind of the treatment administered, will measure the selected skin tag height and diameter in mm before treatment on day 0, day 3, day 15, day 30, day 45 and day 60 if applicable.
At each timepoint after first treatment session, the blinded investigator will rate the treatment success using the following scale:
0= No change
- Improvement
- Disappearance of skin tag
The percentage of subjects having a successful treatment at study end will be calculated for the investigational device and comparator. The treatment is considered successful if the blinded investigator scores the selected skin tag as "2".
If the score is evaluated as 0 or 1 at a follow-up visit, a new treatment will be done (maximum 3 treatments).
Measured: From enrollment to the end of treatment at 60 days (maximum)
Secondary outcomes (6)
Global effectiveness-subjective questionnaire
A subjective evaluation questionnaire, will be filled in by the subjects at study end to evaluate the devices global effectiveness. This questionnaire contains 18 questions concerning effectiveness, where the subjects can score the device with "Agree", "Somewhat Agree", "Neither agree nor disagree", "Disagree" or "Not applicable"
Measured: Study end (day 15, day 30, day 45 or day 60 according to the treatment success)
Skin condition
Evaluation of the skin condition at each timepoint by clinical evaluation by the blinded investigator.
The investigator will evaluate the clinical signs observed on the skin tag and on the healthy skin surrounding the skin tag before treatment on day 0, day 3, day 15, day 30, day 45 and day 60 if applicable using the following clinical scores:
- None (0)
- Mild (1)
- Moderate (2)
- Severe (3)
Measured: From enrollment to the end of the treatment at 60 days (maximum)
Pain during treatment by the subject
The subjects will be asked to evaluate the pain felt during each treatment on a visual analogic scale of 10 cm.
Measured: From enrollment to the end of treatment at 60 days (maximum)
Pain and healing process by the subject
The subjects will score every day until next visit in their daily diary the following signs: pain (scale: none, mild, moderate, severe) as well as redness, black colour, blister, wound and scab (scale: absence, presence) in order to evaluate the healing process. The subjects will also be asked to write down any other intolerance reactions that have occurred during the study in the diary.
Measured: From enrolment to the end of treatment at 60 days (maximum)
Global tolerability
According to the signs observed at each timepoint, the global tolerability of the investigational device and comparator will be defined by the blinded investigator on the following scale at the study end:
0= Bad tolerance:
- Moderate tolerance
- Good tolerance
- Very good tolerance.
Measured: Study end (Day 15, Day 30, Day 45 or Day 60 according to the treatment success)
Amount and severity of Adverse Events (AEs)
General tolerance by collection of amount and severity of Adverse Events (AEs) by the blinded investigator for the whole study period.
Measured: From enrolment to the end of treatment at 60 days (maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start6 Oct 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355543
- Sponsor's protocol ID
- 25-0952-U5
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Centre, Single-blinded, Randomized Clinical Investigation to Evaluate the Effectiveness and Safety of a Cryogenic Device to Treat Skin Tags Versus a Comparator Product.
- ClinicalTrials.gov ID
- NCT07355543
- Acronym / sponsor ID
- 25-0952-U5
- Conditions
- Skin Tags
- Keywords
- NITROFREEZE SKIN TAG, SKIN TAG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
The purpose of this clinical investigation is to evaluate the effectiveness and safety of Nitrofreeze Skin Tag for the treatment of skin tags versus a comparator device (Scholl Freeze Away® Skin Tag Remover).
Detailed description
The primary objective of the study is to assess the efficacy of Nitrofreeze Skin Tag (tested product) for the treatment of skin tags versus a comparator product.
The secondary objectives are to assess the safety of the tested product versus comparator product.
To meet these objectives, the subjects will be monitored as follows:
At the screening visit (visit 1), the study will be explained to the subject by the investigator before any study related procedures are performed. Both the subject and the investigator will sign the consent form and the investigator will check inclusion and exclusion criteria. This can also be done at the D0 visit.
At visit 2 on D0, if the subject is eligible, the subject will perform the first treatment on the selected skin tag with the tested product or comparator, at the lab.
At visit 3 on D3, the investigator will evaluate the skin condition on and around the skin tag and collect adverse events.
At visit 4 on D15, assessment of effectiveness and safety will be made. A second treatment can be done if first treatment is not effective. Study end if the skin tag was successfully removed.
At visit 5 on D30, assessment of effectiveness and safety will be made. A third treatment can be done if second treatment is not effective. Study end if the skin tag was successfully removed.
At visit 6 on D45, assessment of effectiveness and safety will be made. Study end.
In case of missing treatment on D15 or D30 because of a missing visit or a skin condition that did not permit a new treatment, the third treatment will be done on D45. In that case, a new follow-up visit will be done at D60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NITROFREEZE SKIN TAG | Experimental | Device: NITROFREEZE Skin tagTopical application on the selected skin tag for 20 seconds. Maximum of 3 treatments with a 15 days interval between each treatment. |
| Scholl Freeze Away Skin Tag Remover | Active comparator | Device: Scholl Freeze Away Skin Tag RemoverTopical application on the selected skin tag for 40 seconds. Skin tag can be removed in 1 treatment. If the skin tag has not fallen off in 2 weeks, you may treat the skin tag again, up to 3 treatment cycles. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy subject.
- Sex: male or female.
- Age: more than 22 years old.
- Phototype: I to III according to Fitzpatrick.
- Subject presenting at least one skin tag that could be treated by the tested devices as evaluated by the investigator:
Key exclusion criteria (28 listed)
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
- Subject enrolled in another clinical trial or which exclusion period is not over.
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 |
|---|---|---|
| NITROFREEZE Skin tagTreatment of the skin tag with NITROFREEZE Skin Tag device on Day 0, Day 15, Day 30. | Device | NITROFREEZE SKIN TAG |
| Scholl Freeze Away Skin Tag RemoverTreatment of the skin tag with Scholl Freeze Away Skin Tag Remover device on Day 0, Day 15, Day 30. | Device | Scholl Freeze Away Skin Tag Remover |
Primary outcome
Cure rate
Time frame: From enrollment to the end of treatment at 60 days (maximum)
Comparison of the percentage of subjects having a successful treatment of the selected skin tag in the Nitrofreeze Skin Tag group versus comparator group by clinical evaluation by the blinded evaluator. The investigator, who will be in blind of the treatment administered, will measure the selected skin tag height and diameter in mm before treatment on day 0, day 3, day 15, day 30, day 45 and day 60 if applicable. At each timepoint after first treatment session, the blinded investigator will rate the treatment success using the following scale: 0= No change 1. Improvement 2. Disappearance of skin tag The percentage of subjects having a successful treatment at study end will be calculated for the investigational device and comparator. The treatment is considered successful if the blinded investigator scores the selected skin tag as "2". If the score is evaluated as 0 or 1 at a follow-up visit, a new treatment will be done (maximum 3 treatments).
6 secondary outcomes
Global effectiveness-subjective questionnaire
Time frame: Study end (day 15, day 30, day 45 or day 60 according to the treatment success)
Skin condition
Time frame: From enrollment to the end of the treatment at 60 days (maximum)
Pain during treatment by the subject
Time frame: From enrollment to the end of treatment at 60 days (maximum)
Pain and healing process by the subject
Time frame: From enrolment to the end of treatment at 60 days (maximum)
Global tolerability
Time frame: Study end (Day 15, Day 30, Day 45 or Day 60 according to the treatment success)
Amount and severity of Adverse Events (AEs)
Time frame: From enrolment to the end of treatment at 60 days (maximum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Eurofins Dermscan Pharmascan
Villeurbanne, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NITROFREEZE Skin tag and Scholl Freeze Away 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 13 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: From enrollment to the end of treatment at 60 days (maximum)). 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 21 Jan 2026.