Nitrofreeze cryogenic pen versus Scholl Freeze Away for removing skin tags
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.
NA · Oystershell NV · NCT07355543
This test will try whether the Nitrofreeze cryogenic pen safely removes small skin tags as well as the Scholl Freeze Away device in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Oystershell NV (industry) |
| Locations | 1 site (Villeurbanne) |
| Trial ID | NCT07355543 on ClinicalTrials.gov |
What this trial studies
Adults with small, soft, skin-colored skin tags (2–5 mm) will be enrolled and treated at a clinical site with either the Nitrofreeze device or the Scholl Freeze Away comparator. Treatments occur on day 0 with follow-up visits at day 3, 15, 30 and 45, and up to three treatments are allowed if needed. The main outcome is tag removal; safety and adverse events will be recorded throughout the follow-up. Eligibility requires age over 22 and Fitzpatrick phototypes I–III among other criteria.
Who should consider this trial
Good fit: Adults over 22 with one or more soft, flexible, skin-colored skin tags 2–5 mm in size located on the neck, chest, back, groin or underarm and with Fitzpatrick skin types I–III.
Not a fit: People who are pregnant or nursing, have darker skin tones (phototypes IV–VI), have larger or firmer lesions, have lesions in excluded locations, or have other interfering skin conditions may not be suitable or likely to benefit.
Why it matters
Potential benefit: If successful, this device could provide a simple, non-surgical way to remove small skin tags with minimal clinic time.
How similar studies have performed: Over-the-counter cryotherapy devices such as Scholl Freeze Away have been used for skin tag removal before, so the approach is established though device performance can vary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Healthy subject.
2. Sex: male or female.
3. Age: more than 22 years old.
4. Phototype: I to III according to Fitzpatrick.
5. 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;
* 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.
6. Subject having given freely and expressly his/her informed consent.
7. Subject who is able to comply with the study requirements, as defined in the present CIP, at the investigator's appreciation.
8. Subject affiliated to a health social security system.
9. 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.
Exclusion Criteria:
1. Pregnant or nursing woman or planning a pregnancy during the study.
2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
3. Subject in a social or sanitary establishment.
4. Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
5. Subject enrolled in another clinical trial or which exclusion period is not over.
6. Member of the CRO or the centre staff.
7. Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
8. Subject suffering from a severe or progressive disease (including asthma and diabetes).
9. Subject with immune deficiency or autoimmune disease.
10. Subject suffering from an acute or cutaneous disease or any other cutaneous pathology.
11. Subject with a history of skin cancer or pre-cancerous skin lesions.
12. Subject with previous event of healing disorders such as hypertrophic or keloid scar, residual pigmentation etc.
13. Subject with blood circulation or blood clotting problems including Raynaud's disease; blood dyscrasias of unknown origin; haemophilia subjects.
14. Subject presenting skin growths such as birthmarks, moles, warts, or any other unusual-looking skin condition on the treated zone.
15. Subject having thin, inflamed, damaged, irritated, itchy, infected, cut, grazed, diseased or red skin on and around the treated zone.
16. Subject with molluscum contagiosum, blisters or any other vesicles on the skin on and around the treated zone.
17. Subject with a known allergy to Chlorhexidine based antiseptic or to adhesives.
18. Subject who already had an abnormal reaction to cold.
19. Subject whose selected skin tag is bleeding or scratched.
20. Subject whose skin tag is located on the face, scalp or mucosa, anus, genitals, buttocks, lips, eyelids or eyes.
21. 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.
22. Subject who received a treatment of any kind on the selected skin tag within 6 months prior to D0 visit.
23. Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen exposure of the treated zone during the study.
Where this trial is running
Villeurbanne
- Eurofins Dermscan Pharmascan — Villeurbanne, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Skin Tags, NITROFREEZE SKIN TAG, SKIN TAG