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.
1 other identifier
interventional
56
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2019
CompletedFirst Submitted
Initial submission to the registry
March 12, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedMarch 18, 2024
March 1, 2024
3 months
March 12, 2024
March 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Number of treatments
day 45 +-2 days
Visual aspect
Every day (for a period of 45 days +- 2 days)
Macrophotographs on skin tag remission
Day 0 (before treatment); day 15 (before treatment); day 30 (before treatment) and day 45 if applicable.
Evaluation of the skin condition
Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days)
Degree of pain
During treatement on day 0, and if applicable on follow-up treatments on day 15 and day 30.
- +1 more secondary outcomes
Study Arms (2)
Pixie® skin tag
EXPERIMENTALA skin tag is selected and treated with the test device Pixie® skin tag according to the instructions for use.
Wortie® skin tag remover
ACTIVE COMPARATORA skin tag is selected and treated with the comparator Wortie® skin tag remover.
Interventions
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.
The skin tag is treated by treatment with the cryogenic device. The frozen metal nib is applied on the skin tag for 40 seconds.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oystershell NVlead
Study Sites (1)
DERMSCAN - PharmScan
Villeurbanne, 69100, France
Study Officials
- PRINCIPAL INVESTIGATOR
Emilie Bathelier, PhD
Dermscan/Pharmascan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2024
First Posted
March 18, 2024
Study Start
October 4, 2018
Primary Completion
January 7, 2019
Study Completion
March 11, 2019
Last Updated
March 18, 2024
Record last verified: 2024-03