Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of an Ozonated Oil in Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in SCORAD score from baseline at days 7 and 14
研究概览
简要总结
This clinical trial is designed to evaluate the efficacy, safety, and tolerability of a topical ozonated vegetable oil formulation in paediatric patients with mild-to-moderate atopic dermatitis. The study follows a randomised, double-blind, placebo-controlled design and compares clinical progression, as assessed using the SCORAD (Scoring Atopic Dermatitis) index, quality of life, as measured using the IDQoL (Infants' Dermatitis Quality of Life Index), and various safety and cosmetic acceptability outcomes over a 14-day follow-up period. In addition to conventional clinical efficacy endpoints, the study includes responder analyses and quality-of-life assessments to provide a more comprehensive characterisation of the potential therapeutic benefit of ozonated oil in this population.
详细描述
A pilot, randomised, double-blind, placebo-controlled clinical trial is conducted to evaluate the clinical efficacy, safety, and tolerability of a topical formulation based on ozonated vegetable oil in paediatric patients with mild-to-moderate atopic dermatitis.
The primary objective of the study is to evaluate the clinical efficacy of topical ozonated oil in reducing the severity of paediatric atopic dermatitis, as quantified by the change in the total SCORAD score from baseline to the follow-up visits, from both a continuous perspective, based on the absolute change in SCORAD, and a clinical-response perspective.
The secondary objectives are:
To evaluate the impact of treatment on atopic dermatitis-related quality of life using the IDQoL questionnaire.
To evaluate the proportion of patients achieving clinically meaningful improvements in SCORAD according to the minimal clinically important difference (MCID) criteria.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Month 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 1 month and 6 years.
- •Clinical diagnosis of atopic dermatitis.
- •Active mild or moderate flare.
- •Baseline SCORAD score between 20 and 50 points.
- •Availability of parents or legal guardians to administer the treatment and complete the follow-up period.
- •Written informed consent provided by the parents or legal guardians.
排除标准
- •Severe atopic dermatitis.
- •Clinically relevant active skin infection.
- •Recent use of systemic immunosuppressive treatments.
- •Serious concomitant diseases.
- •Known hypersensitivity to any component of the formulation.
- •Clinical conditions that could interfere with the interpretation of the therapeutic response.
结局指标
主要结局
Change in SCORAD score from baseline at days 7 and 14
时间窗: 14 days
The primary efficacy outcome is the total SCORAD (Scoring Atopic Dermatitis) score, a widely validated instrument for the clinical assessment of atopic dermatitis. Three SCORAD assessments are performed throughout the study: at baseline, day 7, and day 14. The SCORAD index comprises three domains: \- SCORAD A: Extent This domain assesses the percentage of body surface area affected. In patients younger than 2 years of age, age-specific anatomical weightings for the paediatric population are applied. \- SCORAD B: Intensity This domain includes the clinical assessment of six dermatological signs: erythema, oedema, oozing/crusting, excoriation, lichenification, and xerosis. Each item is scored on an ordinal scale from 0 to 3. \- SCORAD C: Subjective symptoms This domain assesses the perceived severity of pruritus and sleep disturbance, each quantified on a scale from 0 to 10. \- The total SCORAD score is calculated using the standard formula: SCORAD = A/5 + (7 × B)/2 + C
次要结局
- Number and percentage of patients achieving a SCORAD response at days 7 and 14 relative to baseline(14 days)
- Change in IDQoL score from baseline at day 7(7 days)
- Number and percentage of patients requiring rescue medication during the 14-day follow-up period(14 days)
- Number of days of rescue medication use during the 14-day follow-up period.(14 days)