OBSERVATIONAL STUDY OF THE EFFICACY ON SENSITIVE SKIN OF AN ORAL FORMULATION BASED ON PURPLE BASIL, FOR 8 WEEKS IN 2 GROUPS OF 100 VOLUNTEERS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitive skin symptoms
研究概览
简要总结
Stress can have multiple and varied psychological and clinical impacts on skin diseases (Colavincenzo and Granstein, 2006; Graubard et al., 2021). In particular, psychological stress has been shown to reduce the rebuilding kinetics of the skin barrier when altered and it is suggested that psychological stress may trigger or exacerbate immune-mediated dermatological disorders (Hall et al., 2012). Certain symptoms related to sensitive skin problems (itching, burning, pain, etc.) can lead to sleep disorders associated with stress and anxiety. Conversely, these sleep disorders and anxiety or stress due to external sources are known to promote the appearance of symptoms related to skin sensitivity in patients who are at risk of developing sensitive skin syndrome (Farage, 2022).
Expanscience Laboratories, manufacturer of cosmetics and dietary supplements, has identified a HOLY BASIL plant extract as a solution to address the negative impacts of stress on sensitive skin symptoms.
The main goal of this double blinded randomized controlled clinical study is to evaluate in vivo the effect of an active ingredient HOLY BASIL incorporated into a food supplement on sensitive skin symptoms related to psychological stress after 28 and 56 consecutive days of a twice-daily intake, in comparison with the baseline and a placebo. Evaluation of the effectiveness of HOLY BASIL will be evaluated using psychometric questionnaires related to stress, sensitive skin and overall perception.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gender: Women
- •People aged between 45 and 65 years.
- •Presenting sensitive skin (Sensitive Scale 10 ≥ 20) with Tightness ≥ 4 and general malaise ≥
- •People who report being stressed (PSS10 questionnaire ≥ 14) and who report a relationship between skin sensitivity and psychological stress (according to the volunteer's opinion).
- •Last participation in a clinical study on the face, which ended at least 8 weeks before the start of this study.
- •Washing phase of 15 days without application of products on the face, or oral intake.
排除标准
- •People with gastrointestinal diseases (diabetes, gastritis, Crohn's disease, celiac disease, ulcers, intolerances, etc.).
- •People with allergies to 'purple basil' or its excipients (maltodextrin, magnesium stearate).
- •Have other physiological disorders (diabetes, hypertension, dyslipidemia) and/or gallstones.
- •Individuals under medical treatment in the weeks prior to the study, which may interfere with the evaluations of the present study.
- •People who are pregnant or intend to be pregnant within the study period, as well as people who are breastfeeding.
- •People who are within a dietary period outside of their usual habit, or intend to change their eating routine during the study period.
- •People participating in another clinical study with similar characteristics (according to the investigator's criteria), during the study period.
研究组 & 干预措施
Active product
Administration of HOLY BASIL
干预措施: Holy basil extract (Dietary Supplement)
Placebo product
Administration of Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Sensitive skin symptoms
时间窗: At baseline and after 28 days and 56 days
Evaluation using Sensitive Scale-10 (SS-10) questionnaire
次要结局
- Perceived stress(At baseline and after 28 days and 56 days)
- Self perception(After 28 days and 56 days)