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

NCT ID: NCT06315946

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2019-03-11

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.

Conditions

Skin Tags

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pixie® skin tag

A skin tag is selected and treated with the test device Pixie® skin tag according to the instructions for use.

Group Type: EXPERIMENTAL

Pixie® skin tag

Intervention Type: DEVICE

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.

Wortie® skin tag remover

A skin tag is selected and treated with the comparator Wortie® skin tag remover.

Group Type: ACTIVE_COMPARATOR

Wortie® Skin Tag Remover

Intervention Type: DEVICE

The skin tag is treated by treatment with the cryogenic device. The frozen metal nib is applied on the skin tag for 40 seconds.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oystershell NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Bathelier, PhD

Role: PRINCIPAL_INVESTIGATOR

Dermscan/Pharmascan

Locations

DERMSCAN - PharmScan

Villeurbanne, , France

Countries

France

Other Identifiers

17E3241

Identifier Type: -

Identifier Source: org_study_id