Actively Recruiting
Evaluate the Effectiveness and Safety of a Cryogenic Pen to Treat Skin Tags Versus a Comparator.
Led by Oystershell NV · Updated on 2026-01-21
56
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
O
Oystershell NV
Lead Sponsor
E
Eurofins Dermscan Pharmascan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluate the Effectiveness and Safety of a Cryogenic Pen to Treat Skin Tags Versus a Comparator.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy subject
- Male or female
- Age over 22 years
- Skin phototype I to III according to Fitzpatrick
- Presence of at least one skin tag suitable for treatment located on neck, chest, back, groin, or underarm
- Skin tags must be soft, flexible, similar in color to surrounding skin, and 2 to 5 mm in size
- Provided informed consent
- Able to comply with study requirements
- Affiliated to a health social security system
- Females of childbearing potential must use effective contraception for at least 12 weeks before screening and during the study
You will not qualify if you...
- Pregnant or nursing women or planning pregnancy during the study
- Subject deprived of freedom by legal decision or under guardianship
- Resident in social or sanitary establishment
- Received over 6000 euros for clinical research participation in last 12 months
- Enrolled in another clinical trial or within exclusion period
- Member of CRO or center staff
- Condition or medication causing undue risk per investigator
- Severe or progressive disease including asthma and diabetes
- Immune deficiency or autoimmune disease
- Acute or chronic skin disease or pathology
- History of skin cancer or pre-cancerous lesions
- History of abnormal healing such as hypertrophic or keloid scars
- Blood circulation or clotting disorders including Raynaud's disease or haemophilia
- Presence of unusual skin growths like moles, warts, or birthmarks on treatment area
- Damaged, irritated, infected, or inflamed skin on or around treatment area
- Molluscum contagiosum, blisters, or vesicles near treatment area
- Allergy to Chlorhexidine antiseptic or adhesives
- Previous abnormal reaction to cold
- Skin tag bleeding or scratched
- Skin tag located on face, scalp, mucosa, anus, genitals, buttocks, lips, eyelids, or eyes
- Use of topical or systemic treatments affecting test area or coagulation within specified timeframes
- Treatment on selected skin tag within 6 months prior to Day 0
- Recent or planned intensive sun or UV exposure on treated area during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Eurofins Dermscan Pharmascan
Villeurbanne, France, 69100
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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