Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.

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).

Study Overview

• Status: Completed
• Conditions: Skin Tags
• Intervention / Treatment: Device: Pixie® skin tag; Device: 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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • DERMSCAN - PharmScan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pixie® skin tag; A skin tag is selected and treated with the test device Pixie® skin tag according to the instructions for use.	Device: Pixie® skin tag; 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.
Active Comparator: Wortie® skin tag remover; A skin tag is selected and treated with the comparator Wortie® skin tag remover.	Device: Wortie® Skin Tag Remover; The skin tag is treated by treatment with the cryogenic device. The frozen metal nib is applied on the skin tag for 40 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 45 +-2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 45 +-2 days
Visual aspect	Evaluation of devices efficacy by subjects' self-assessment, using a subjective evaluation questionnaire completed at the study end.	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.	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.	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.	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.	Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)

Collaborators and Investigators

• Sponsor: Oystershell NV
• Investigators: Principal Investigator: Emilie Bathelier, PhD, Dermscan/Pharmascan

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Actual): January 7, 2019
• Study Completion (Actual): March 11, 2019

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 17E3241

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No