Efficacy of a food supplement in protecting the skin from the sun and reducing dark spots

Not Applicable

• Conditions: Subjects with phototypes from I to III, showing hyperpigmentation, with at least one spot with a minimum diameter of 3 mm; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN34155374
• Lead Sponsor: Activ'inside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-08
• Last Update Posted: 22 April 2024
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
V protection evaluated by the assessment of the minimal erythemal dose (MED) at T0, T42 and T84. MED is performed by applying a series of UV exposures, using a model 601-300W solar simulator (Solar Light Co. Inc, Philadelphia, USA). Skin redness reaction after UV exposure is measured in the MED skin site using a colorimeter/spectrophotometer CM-700D (Konica Minolta). The parameter measured is the a* parameter of the CIELAB (1976) chromatic space. Digital pictures of the MED area were acquired using a digital camera at baseline (T0), 42 days (T42) and 84 days (T84).