ISRCTN12882379进行中（未招募）Unknown
A clinical trial aimed to evaluate the whitening efficacy of a dietary supplement in healthy adults. Multi-ethnic panel. Double-blind controlled study versus placebo
ROELMI HPC Srl0 个研究点目标入组 66 人开始时间: 2023年7月20日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy female and male subjects
- •2. Age between 25 and 65 (extremes included) years old
- •3. Multi-ethnic panel
- •4. Subjects showing skin spots related to age, sun exposure or post-inflammatory hyperpigmentation
- •5. Subjects who have not been recently involved in any other similar study (at least one month of wash-out)
- •6. Willingness to not use during the study period products other than the test product
- •7. Willingness to not vary the normal diet and daily routine (at the beginning of the study volunteers will list their usual routine: sports activities, sleeping habits, etc.)
- •8. Subject is under effective contraception (oral/not oral) therapy
- •9. Subjects who accept not to expose in an intensive way to UV rays during the whole study duration
- •10. Subjects registered with Nation Health Service (NHS)
- •11. Subjects certifying the truthfulness of the personal data disclosed to the investigator
- •12. Subjects able to understand the language used in the investigation center and the information given by the investigator
- •13. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- •14. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
- •15. Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
排除标准
- •1. Subject does not meet the inclusion criteria
- •2. Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- •3. Subjects participating or planning to participate in other clinical trials
- •4. Subjects not able to be contacted in case of emergency
- •5. Subjects admitted to a health or social facility
- •6. Subjects planning a hospitalization during the study
- •7. Subjects who participated in a similar study without respecting an adequate washout period (at least one month of wash-out)
- •8. Subject with known or suspected sensitization to one or more test formulation ingredients
- •9. Having a diagnosed chronic disease (blood, cardio-vascular, psychiatric, neuro-degenerative, cancer, liver, gastric, skin, etc.) and/or under medical treatment; in particular subjects suffering from hypertension, renal insufficiency, liver cirrhosis and diabetes will be excluded from the trial
- •10. Consumption of food supplement(s) and/or use of topical skincare products with whitening activity currently or within the past 4 weeks before the study: moreover the assumption of foods containing liquorice is not recommended for the entire duration of the study
- •11. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated)
- •12. Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function
- •13. Subjects accustomed to using tanning beds
- •14. Subjects taking medication with photosensitizing potential, drugs and/or dietary supplements able to induce skin coloring, corticoids, currently or during the month before the study
- •15. Subjects under pharmacological treatments that are considered incompatible with the study requirements by the investigator
- •16. Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •17. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patches or medical devices
- •18. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
研究者
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