Clinical trial NCT06315946: Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.
Official title: Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Tags
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Percentage of subjects with successful treatment
timeFrame: day 45 +-2 days
Secondary outcomes:
measure: Number of treatments
timeFrame: day 45 +-2 days
measure: Visual aspect
timeFrame: Every day (for a period of 45 days +- 2 days)
measure: Macrophotographs on skin tag remission
timeFrame: Day 0 (before treatment); day 15 (before treatment); day 30 (before treatment) and day 45 if applicable.
measure: Evaluation of the skin condition
timeFrame: Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)
measure: Degree of pain
timeFrame: During treatement on day 0, and if applicable on follow-up treatments on day 15 and day 30.
measure: Recording of adverse events
timeFrame: Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: DERMSCAN - PharmScan
Study officials:
affiliation: Dermscan/Pharmascan
name: Emilie Bathelier, PhD
role: PRINCIPAL_INVESTIGATOR
References: