ISRCTN34155374Active, not recruitingUnknown
Short and long-term effect of a dietary supplement on UV protection and dark spots in healthy adults: a randomized, double-blind, placebo-controlled, parallel, clinical trial
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- Activ'inside
- Enrollment
- 66
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Healthy female (80%) and male (20%)
- •2. Caucasian ethnicity
- •3. Phototypes from I to III
- •4. Age between 28 and 52 years inclusive
- •5. Subject showing skin spots related to age, sun exposure or post-inflammatory hyperpigmentation, with at least one spot with a minimum diameter of 3 mm
- •6. Willingness to not consume during the study period products other than the test product as judged by the investigator,
- •7. Subjects registered with the National Health Service (NHS)
- •8. Subjects certifying the truthfulness of the personal data disclosed to the investigator
- •9. Subjects able to understand the language used in the investigation centre and the information given by the investigator
- •10. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- •11. 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
- •12. Commitment not to change the daily routine or the lifestyle
- •13. Subjects who have not been recently involved in any other similar study (at least one month of wash-out)
- •14. Subject under effective contraception (oral/not oral) therapy
- •15. Subjects who accept not to be exposed in an intensive way to UV rays during the whole study duration
- •16. Subject is aware of the study procedures and has signed an informed consent form and privacy information form.
Exclusion Criteria
- •1. Subject does not meet the inclusion criteria
- •2. Subjects participating or planning to participate in other clinical trials
- •3. Subjects deprived of freedom by administrative or legal decision or under guardianship
- •4. Subjects not able to be contacted in case of emergency
- •5. Subjects admitted to a health or social facility
- •6. Subjects planning a hospitalisation during the study
- •7. Subjects who participated in a similar study without respecting an adequate washout period
- •8. Subjects having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •9. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator
- •10. 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
- •11. Subject with known or suspected sensitization to one or more test formulation ingredients
- •12. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
- •13. Consumption of food supplement(s) and/or use of topical skincare products that have an influence on skin response to UV rays or dark spots (currently or within the past 4 weeks before the study)
- •14. Subjects accustomed to use tanning beds
- •15. 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
Investigators
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