Ocular, Periocular and Cutaneous Tolerance and Efficacy of Formula 2039002 10 Product in Patients With Palpebral Eczema During 4 Weeks Under Dermatological and Ophthalmological Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- change in clinical assessment of efficacy items
研究概览
简要总结
The eyelids are particularly susceptible to eczema. Eyelid eczemas also called palpebral eczema, are a common condition that causes the skin on or around the eyelid to become dry, itchy, and irritated.
The study aims at evaluating the ocular and peri-ocular tolerance and the efficacy of the investigational product under normal conditions of use in participants with a palpebral eczema ground.
This open-labeled, multicentric study was conducted under dermatological and ophthalmological control in Caucasian subjects over 18 years of age, of all skin types and having a sensitive skin, especially on eye contour. The investigational product was to be applied twice daily on eyes contour for 4 weeks.
详细描述
The evaluation of the investigational product in participants with a palpebral eczema ground has been conducted under dermatological and ophthalmological control by Dermatech.
The study was conducted in the spirit of the French and European Guidelines for Good Clinical Practice, the recommendations of the International Conference on Harmonization (ICH) and according to the Helsinki Declaration in its latest version (Seoul 2008) and the General Data Protection Regulation (GDPR).
A 35-patient panel is considered as enough size to reach study objectives. The following statistical analysis are performed after data control and randomisation released.
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Excluded data: In case of incoherent /aberrant value, it could be decided to exclude the data from the analysis (a justification will be brought).
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Protocol deviation: All deviations from the protocol are listed. Deviations that may have an impact on the study results are identified.
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Initial characteristics: The initial characteristics of the patients will be summarized using descriptive statistics (means, minimum and maximum values for quantitative variables, absolute and relative frequencies for qualitative variables).
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Clinical assessment and self-assessment scales:
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Calculation of mean and standard deviation at each time point at Day0 Time0 (D0T0), Day0 Time10 minutes (D0T10min), D14 and Day28 Time0 (D28T0) for the clinical assessment and at D0T0, D14 and D28T0 for the self-assessment scales.
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Evaluation of time effect using a linear mixed effect model, with time (at D0T0, D0T10min, D14 and D28T0 for the clinical assessment and at D0T0, D14 and D28T0 for the self-assessment scales) as a fixed effect, and patients as a random effect to take into account that several measurements were performed on each patient.
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In case of significance of the time effect, multiple comparisons among timepoints will be performed with Tukey adjustment). In case of non-convergence of the linear mixed effect model, a logistic mixed effect model could be performed as an alternative, where modalities would be grouped into two modalities (presence/absence of sign).
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Questionnaire of cosmetic acceptability: Calculation of effective and percentages of positive answers.
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Quality of life questionnaires: Qualitative variables will be summarized by effective and percentages. Quantitative variables will be summarized by mean and standard deviation, median and quartiles, and range.
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Safety analysis: Interpretation of safety data was performed by analyzing each reaction, attributable to the application of study product (reactions reported by patient in the daily log questionnaire and reactions reported by investigator during examination). The investigator gives his conclusion on the investigational product cutaneous acceptability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •caucasian
- •phototype I to IV
- •palpebral eczema ground (blepharitis, epiphora, chronic whimpering/watery eyes)
- •sensitive skin and especially on eye contour
- •all skin types of eyes contours
- •not tanned on the face (no sun or artificial U.V. exposure for at least a month)
- •no exfoliation, scrubbing or peeling of the whole face for at least 2 weeks
排除标准
- •at least one ocular functional sign at inclusion day
- •receiving a medication which, in the investigator's judgment, places the patient at undue risk
- •an intra-ocular surgery within the 6 months preceding the beginning of the study
- •an ocular laser session, within the month preceding the beginning of the study
结局指标
主要结局
change in clinical assessment of efficacy items
时间窗: change from baseline to Day28 Time0
irritated aspect of the eye contours, swelling of eye contours on a 6-point scale
次要结局
- change in self-assessment of efficacy items(change from baseline to Day28 Time0)
- change in quality of life(change from baseline to Day28 Time0)
- change in dermatological evaluation of the tolerance - functional signs(change from baseline to Day28 Time10minutes)
- change in ophthalmological evaluation of the tolerance - physical signs(change from baseline to Day28 Time10minutes)
- change in ophthalmological evaluation of the tolerance - functional signs(change from baseline to Day28 Time10minutes)
- global acceptability of the ocular and peri-ocular area(Day28)
- change in dermatological evaluation of the tolerance - clinical signs(change from baseline to Day28 Time10minutes)
- change in sensitivity and quality of life of patients(change from baseline to Day28 Time0)
- cutaneous acceptability and efficacy(Day28 Time0)