Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 58
- 试验地点
- 6
- 主要终点
- Clinical Improvement of Patients with Dermatitis
研究概览
简要总结
To verify the efficacy and tolerability of Activated Piroctone Olamine (Blue Cap Foam, label volume 100 ml) by CATALYSIS, S. L. Madrid, applied in the management of all types of dermatitis (atopic, seborrheic, eczema) in patients with significant manifestations of the disease in varying areas of the body of varying extent and to assess differences in individual tolerability and the final effect in a group of selected patients aged 3 to 18 years.
详细描述
The first reports on the possibility of using Activated Piroctone Olamine as an effective treatment for patients with papulosquamous dermatoses, eczema and seborrhoeic dermatitis date back to the 1970s. The observations are presented in scientific papers by dermatologists, pharmacologists and laboratory workers who have verified the original thesis in practice by the practical use of different types of products. Activated Piroctone Olamine as an active ingredient is now used by a number of companies in their product range, either as the only active ingredient or, for example, in combination with other active ingredients such as liquid carbonis detergens. The Spanish company CATALYSIS S.L Madrid has also started to produce preparations containing Activated Piroctone Olamine intended for targeted use in dermatological practice. The products have been named Blue Cap® and the original shampoo has been gradually supplemented by spray, cream and foam formulations. The company has an eminent interest in the serious evaluation of the products and has therefore ordered a number of large clinical multicentre studies carried out in different geographical zones - ranging from the Tropical, through the Temperate to the Siberian regions.
The active ingredient Activated Piroctone Olamine alone or in combination with other active ingredients makes for products with excellent properties. Activated Piroctone Olamine itself has a proven antiseptic, antimicrobial, antifungal and keratolytic effect.
The effect is selective, only acting on the morbidly altered cells. The concentrations of Activated Piroctone Olamine used in BLUE-CAP formulations are absolutely safe. The products can also be used on the surface of larger body areas and in virtually all age groups.
Activated Piroctone Olamine has a number of positive effects on pathological processes in the skin - high antimicrobial and antifungal effect, selective cytostatic effect on skin cells (at the stage of hyperproliferation, but does not affect healthy cells), it regulates the amount and number of cellular enzymes and determines the anti-inflammatory effect (if it is employed in a targeted manner in form of topically applied preparations.
To evaluate the efficacy and safety of the use of Piroctone Olamine in paediatric patients, the following clinical trial was conducted. A commercial formulation of Piroctone Olamine, Blue Cap, in foam format was used on patients aged 3 to 18 years and evaluated for safety and efficacy in the control of symptoms associated with dermatitis.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dermatitis affecting different areas of the body in varying extent.
- •Outpatient status
- •Age of 3 to 18 years, male, female
- •Voluntary participation in the trial
- •Signed informed patient consent form (Parents, legal tutor, or individual)
- •One-time participation in the trial
排除标准
- •Specific exclusion criteria
- •Usage of other systemic preparation which might influence the final assessment (natural preparations, physical therapy)
- •Known allergy to the tested preparation
- •Disease focus infection manifestations (superinfection requiring therapy)
- •Immunosuppressive therapy
- •Malignancies
- •General exclusion criteria:
- •Alcohol and drug abuse.
- •Participation in another clinical trial within the past 30 days.
- •Simultaneous participation in any other clinical trial.
- •Other reasons excluding the patient from the trial.
- •Restricted ability of the patient to follow therapy instructions.
- •Other physical or mental disorders disturbing the trial plan.
- •Possible consent withdrawal, presumed patient unreliability.
结局指标
主要结局
Clinical Improvement of Patients with Dermatitis
时间窗: 45 days
Assessment of the clinical improvement of paediatric patients with dermatitis over the course of the visits using a questionnaire. The global questionnaire assesses the disappearance of clinical manifestations and improvement in skin quality with the following scale: None, Slight, Moderate, Great. The evaluation of each patient is carried out at time 0, 15 days, 30 days, 45 days or on exclusion of the patient.
Grade of Patient Tolerability to the investigation product
时间窗: 45 days
Assessment of tolerance to the application of the test product in paediatric patients. This was done by following and monitoring patients in contact with the Blue Cap product at the topical level by reporting adverse effects during and after use of the product. The assessment of the tolerance of each patient is made throughout the follow-up of the patient (45 days or in case of exclusion of the patient) made by both the investigator and the patient: 1-4 (1- excellent, 2 - very good, 3 - good, 4 - intolerance).
Clinical assessment of symptoms and sings associated with Dermatitis
时间窗: 45 days
Evaluation of the clinical improvement of symptoms and signs associated with dermatitis in paediatric patients by means of a questionnaire on the presence or absence (Yes/No) of the following symptoms: Erythema, Scaling, Infiltration, Excoriations, Lichenification, Xerosis, Pruritus. The evaluation of each patient is carried out at time 0, 15 days, 30 days, 45 days or on exclusion of the patient.
次要结局
- Evaluation of the therapeutic effect of Blue Cap on healing of the skin at the patients(45 days)
- Evaluation of the therapeutic effect of Blue Cap in paediatric patients with dermatitis.(45 days)