Evaluation of Toleriane Ultra Reno in Allergic Subjects Having Skin Intolerance to Their Usual Cosmetic Care for One Month
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- change in transepidermal water loss
研究概览
简要总结
Sensitive skin is a subjective cutaneous hyper-reactivity to environmental factors. People report exaggerated reactions when their skin, especially on the face, is in contact with substances such as cosmetics. For this reason, Toleriane Ultra has been developed to limit the risk of allergy and relieve skin discomfort. The study aims at demonstrating that Toleriane Ultra is well tolerated in participants with allergic background and having experienced former intolerance to their cosmetic or toiletries routine, and improves skin sensitivity in such individuals.
This open-labeled, multicenter study was conducted under dermatological control in Caucasian subjects above 16 years of age with an allergic background and intolerance to cosmetics lasting for at least 2 years prior to inclusion. The dermocosmetic product was to be applied on the entire face twice daily for 28 days.
详细描述
The evaluation of Toleriane Ultra in allergic subjects having skin intolerance to their usual cosmetic care has been conducted under cosmetic form and dermatological control by Dermscan that is certified by the International Standards Organization (ISO) 9001-2015.
Each study report is subjected to a quality inspection by a member of Dermscan. A certificate of quality inspection signed by a proofreader (not involved in the audited study) is enclosed in each study. The inspection of the study report allows to confirm that the results reflect exactly the study raw data and that the study fulfills any standard and regulatory requirements.
With regard to the statistical analysis, the continuous data is summarized using the following statistics by time point (Day0, Day14, Day28): number of values, mean, median, standard deviation, minimum value, maximum value. For each continuous data obtained from devices (Tewameter for Transepidermal water loss, Corneometer for cutaneous hydration measurements), a mixed linear model for repeated measurements is adjusted to raw data, including the factor "time" as fixed (with 3 levels: Day0, Day14, Day28) and the factor "subject" as random. Using the adjusted means obtained from this model (LS-Means), the contrast of interest is built to assess the change from baseline (Day0) at each point (Day14 and D28). For the categorical data, the global tolerance scores by both the investigator and the participant assessed using a 4-point scale are summarized in frequency (N) and percentage (%) by time point (Day14, D28) with associated 95% confidential interval. For other categorical data, a Wilcoxon signed rank test is carried out for each parameter assessed using an ordinal scale:
- Sensiscore (erythema, irritation, stinging, itching, burning, tightening, discomfort) assessed using a 5-point structured scale of frequency and intensity of the functional signs.
- Composite score of the skin state (redness, pruritus, dryness, burning sensation, tingling) assessed using a 4-point structured scale.
- Smoothing effect assessed using a 4-point structured scale.
The participants have the right to exit from the study at any time and for any motive, in compliance with the Helsinki Declaration (1964) and its successive updates. The investigator can also interrupt the person's participation in the study prematurely in the case of a disease occurrence, a pregnancy or the occurrence of an adverse reaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •16 years old and above
- •caucasian
- •phototype I to IV
- •participants presenting with an allergy ground
- •participants without visible allergic dermatosis at inclusion on the face
- •participants having skin intolerance with cosmetic care
- •participants who have not changed their cosmetic habits for less than 15 days
排除标准
- •for women: pregnant or nursing or planning a pregnancy during the study
- •cutaneous pathology on the studied zone
- •use of topical or systemic treatment during the previous weeks liable to interfere with assessment of the cutaneous acceptability of the study product
- •professional facial care during the study or within the previous month
- •excessive exposure to sunlight or UV-rays within the previous month
- •participant having undergone surgery under general anesthesia within the previous month
结局指标
主要结局
change in transepidermal water loss
时间窗: Change from baseline to Day28
transepidermal water loss measurements before and after product use with a Tewameter
change in the hydration rate
时间窗: Change from baseline to Day28
hydration rate before and after product use with a Corneometer
change in Sensiscore
时间窗: Change from baseline to Day28
questionnaire on frequency and intensity of functional signs on the face by self-assessment on a 5-point scale
change in cutaneous reactivity score
时间窗: Change from baseline to Day28
cutaneous reactivity score on a 4-point scale (non stinging, mild stinging sensation, moderate stinging sensation, severe stinging sensation) before and after product use with a stinging test
change in cutaneous acceptability
时间窗: Change from baseline to Day28
evaluation of global tolerance by investigator and participants on a 4-point scale
change in composite score
时间窗: Change from baseline to Day28
questionnaire on pruritus, redness, burning and tingling by self-assessment on a 4-point scale
次要结局
未报告次要终点