Open, Non-comparative, Multicentre, Interventional Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Ialuxid® Gel (Hydrogen Peroxide and Hyaluronic Acid) in the Treatment of Acne Vulgaris and Folliculitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Serious Adverse Device event incidence
研究概览
简要总结
The Research Question of the present study is the following: in a population of men and women affected by acne vulgaris, and folliculitis, will Ialuxid® Gel (hydrogen peroxide, hyaluronic acid and glycine) improve the course of the disease, resulting in a decrease of the total number of lesions, results observed after 4 and 8 weeks after the beginning of the treatment?
详细描述
Ialuxid® Gel is a non-antibiotic treatment in gel indicated for use in a variety of skin conditions, and also in case of infection. Its principal ingredient is Ialuvance™ Complex, a proprietary association of hydrogen peroxide, hyaluronic acid, and glycine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged ≥ 18 and ≤ 45 years.
- •Patients diagnosed with acne vulgaris, and folliculitis.
- •a. Only for patients with acne vulgaris: mild to moderate Global Acne Grading Scale score (≤ 30).
- •Patients willing to provide signed informed consent to clinical investigation participation.
- •Patients who agree to discontinue all dermatological treatment and procedures during the study.
- •Patients able to communicate adequately with the Investigator and to comply with the requirements for the study.
排除标准
- •Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception* during the study.
- •*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).
- •Patients with history of allergy or hypersensitivity to Hyaluronic Acid or to any other ingredients of Ialuxid® Gel or hypersensitivity skin reaction to Ialuxid® Gel based on skin test results.
- •History of anaphylaxis or severe complicated allergy symptoms.
- •Patients with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma.
- •Patients who have used oral drugs for acne vulgaris, and folliculitis in the previous month.
- •Patients who have used topical therapies for acne vulgaris, and folliculitis in the previous month.
- •Use of concomitant treatments or procedures aimed to improve skin condition over the last six months before the enrolment, such as chemical peeling, dermabrasion, laser resurfacing.
- •Patients suffering from infectious diseases that would compromise participation, including herpes simplex virus infection, active hepatitis, or human immunodeficiency virus.
- •Patients at risk in term of precautions, warnings and contra-indications referred in the package insert of Ialuxid® Gel.
- •Patients with any facial aesthetic surgery (such as facial contouring surgery: rhinoplasty, chin, or cheek enhancement (through facial implant) or facial rejuvenation surgery: facelift, eyelid lift, neck lift or facial implants etc.) in the preceding 3 months before the enrolment.
- •Patients who received filler injections of any typology in the face in the preceding 3 months.
- •Patients who received botulinum toxin A injections in the face in the preceding 6 months.
- •Need to have direct or indirect contact with quaternary ammonium salts during the study.
- •Patients unlikely to cooperate.
- •Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalization during the study.
- •Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
结局指标
主要结局
Serious Adverse Device event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Change in total number of lesions
时间窗: 8 weeks
To evaluate the overall performance of the medical device Ialuxid Gel in the treatment of acne vulgaris, and folliculitis in terms of change in the total number of lesions, according to lesions count performed by Investigator (sum of lesions present on the body area mainly interested by each disease, to be specified in CRF).
Serious Adverse event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Adverse Device event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Anticipated Serious Adverse Device event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough Anticipated Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Adverse event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Unexpected Serious Adverse Device event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough Unexpected Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.
次要结局
- Treatment satisfaction questionnaire(8 weeks)
- Investigator Global Assessment of Performance (IGAP)(8 weeks)
- Global Acne Grading System (GAGS)(8 weeks)
- Investigator Global Assessment of Performance (IGAS)(8 weeks)
- Dermatology Life Quality Index (DLQI)(8 weeks)
- Change in total number of lesions(4 weeks)
- Total Severity Score (TSS)(8 weeks)
- Patient Global Assessment of Performance (PGAS)(8 weeks)