NCT07355543招募中不适用
Prospective, Single Centre, Single-blinded, Randomized Clinical Investigation to Evaluate the Effectiveness and Safety of a Cryogenic Device to Treat Skin Tags Versus a Comparator Product.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the effectiveness and safety of Nitrofreeze Skin Tag for the treatment of skin tags versus a comparator device (Scholl Freeze Away® Skin Tag Remover).
详细描述
The primary objective of the study is to assess the efficacy of Nitrofreeze Skin Tag (tested product) for the treatment of skin tags versus a comparator product.
The secondary objectives are to assess the safety of the tested product versus comparator product.
To meet these objectives, the subjects will be monitored as follows:
At the screening visit (visit 1), the study will be explained to the subject by the investigator before any study related procedures are performed. Both the subject and the investigator will sign the consent form and the investigator will check inclusion and exclusion criteria. This can also be done at the D0 visit.
At visit 2 on D0, if the subject is eligible, the subject will perform the first treatment on the selected skin tag with the tested product or comparator, at the lab.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subject.
- •Sex: male or female.
- •Age: more than 22 years old.
- •Phototype: I to III according to Fitzpatrick.
- •Subject presenting at least one skin tag that could be treated by the tested devices as evaluated by the investigator:
- •Location: on the neck, chest, back, groin or underarm;
- •Colour: skin tags must be similar in colour to the surrounding skin;
- •Shape & Feel: skin tags must be soft and flexible.
- •Size: 2 to 5 mm in size.
- •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 affiliated to a health social security system.
- •Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during all the study.
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- •Subject in a social or sanitary establishment.
- •Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
- •Subject enrolled in another clinical trial or which exclusion period is not over.
- •Member of the CRO or the centre staff.
- •Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
- •Subject suffering from a severe or progressive disease (including asthma and diabetes).
- •Subject with immune deficiency or autoimmune disease.
- •Subject suffering from an acute or cutaneous disease or any other cutaneous pathology.
- •Subject with a history of skin cancer or pre-cancerous skin lesions.
- •Subject with previous event of healing disorders such 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 presenting skin growths such as birthmarks, moles, warts, or any other unusual-looking skin condition on the treated zone.
- •Subject having thin, inflamed, damaged, irritated, itchy, infected, cut, grazed, diseased or red skin on and around the treated zone.
- •Subject with molluscum contagiosum, blisters or any other vesicles on the skin on and around the treated zone.
- •Subject with a known allergy to Chlorhexidine based antiseptic or to adhesives.
- •Subject who already had an abnormal reaction to cold.
- •Subject whose selected skin tag is bleeding or scratched.
- •Subject whose skin tag is located on the face, scalp or mucosa, anus, genitals, buttocks, lips, eyelids or eyes.
- •Subject undergoing a topical treatment on the test area or a systemic treatment:
- •anti-inflammatory medication within 5 days prior to D0 visit,
- •immunosuppressors and/or corticoids within 10 days prior to D0 visit,
- •retinoids within 6 months prior to D0 visit,
- •treatment with an action on coagulation within 1 week prior to D0 visit,
- •any long-term medication stabilized for less than one month.
- •Subject who received a treatment of any kind on the selected skin tag within 6 months prior to D0 visit.
- •Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen exposure of the treated zone during the study.
研究者
相似试验
招募中
3 期
A Phase 2/3 trial to investigate visualization of the ureters with nizaracianine triflutate, intravenous, in participants aged 18 years or older, undergoing abdominopelvic surgical procedures [TRIPHASE TRIAL].2023-503241-63-00Curadel Surgical Innovations Inc., Curadel Surgical Innovations Inc., Curadel Surgical Innovations B.V.168
招募中
3 期
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose WeightNCT07339423Novo Nordisk A/S1,150
招募中
2 期
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCNCT07269782Shanghai Henlius Biotech60
招募中
1 期
A Phase I study to evaluate the safety and efficacy of L19IL2 in combination with ruxolitinib in patients with advanced solid tumors.2025-522243-17-00Philogen S.p.A.96
招募中
1 期
A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune DiseasesNCT07275736Juventas Cell Therapy Ltd.18