NCT06315946已完成不适用
Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Percentage of subjects with successful treatment
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pixie® skin tag
Experimental
A skin tag is selected and treated with the test device Pixie® skin tag according to the instructions for use.
干预措施: Pixie® skin tag (Device)
Wortie® skin tag remover
Active Comparator
A skin tag is selected and treated with the comparator Wortie® skin tag remover.
干预措施: Wortie® Skin Tag Remover (Device)
结局指标
主要结局
Percentage of subjects with successful treatment
时间窗: day 45 +-2 days
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.
次要结局
- Macrophotographs on skin tag remission(Day 0 (before treatment); day 15 (before treatment); day 30 (before treatment) and day 45 if applicable.)
- Number of treatments(day 45 +-2 days)
- 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.)
- Recording of adverse events(Day 0, Day 3 (+-1day), Day 15 (+-2days), Day 30 (+-2days) and Day 45(+-2days))
- Visual aspect(Every day (for a period of 45 days +- 2 days))
研究者
研究点 (2)
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