An interventional study of Lumenato in Skin, sponsored by LycoRed Ltd.. Completed at 1 site in United States. Open to female participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-18.
Sponsored by LycoRed Ltd. · Not applicable, Interventional, and Treatment
This 12-week study is an open-label study assessing the perceived effectiveness of the Lycored Lumenato supplement on skin health and appearance.
The purpose of this study is to evaluate perceived changes in skin health and appearance after taking the study product daily for 12 weeks. The study product is a soft gel supplement containing tomato oil. This an open-label study, meaning there is no placebo control arm for the study, and everyone enrolled in the study will receive the active study product.
LycoRed Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
tomato oleoresin
Dietary Supplement: Lumenato
tomato oleoresin obtained from yellow dry tomato pulp
Participant perception of the improvement in skin health and appearance from Baseline to Week 12 using the questionnaire responses from FACE-Q™
FACE-Q™ Satisfaction with Skin scale: gathers the participant perspective of their satisfaction or dissatisfaction with their facial skin using a 12-question scale. Participants are asked to choose one of the following responses for each question: Very Dissatisfied (1), Somewhat Dissatisfied (2), Somewhat Satisfied (3) and Very Satisfied (4) for each 12 questions and the sum of scores (or mean of the completed items, in the event of an incomplete scale) gets converted into a score from 0 (worst) to 100 (best).
Time frame: 12 weeks
Baseline Skin Questionnaire
Participant perception of change or maintenance in a variety of skin health parameters over the course of the study using the subjective "Baseline Skin Questionnaire"
Time frame: 12 weeks
End of Study Product Questionnaire"
Participant perception of the study product and study experience as assessed by the "End of Study Product Questionnaire"
Time frame: 12 weeks
Skin Update Questionnaire
Participant perception of change or maintenance in a variety of skin health parameters over the course of the study using the subjective "Update Skin Questionnaire"
Time frame: 12 weeks
Adverse events (AEs) observed during the study, classified by the investigator as to severity, relationship to the study product/protocol, and seriousness
classified by the investigator
Time frame: 14 weeks
Compliance to the daily use of the Lycored Lumenato supplement through monitoring within ClaimIt (Weekly e-Diary)
Weekly e-Diary
Time frame: 12 weeks
Sustainability of effect after two weeks without supplementation as assessed by the Week 14 FACE-Q™ Satisfaction with Skin scale
FACE-Q™ Satisfaction with Skin scale: gathers the participant perspective of their satisfaction or dissatisfaction with their facial skin using a 12-question scale. Participants are asked to choose one of the following responses for each question: Very Dissatisfied (1), Somewhat Dissatisfied (2), Somewhat Satisfied (3) and Very Satisfied (4) for each 12 questions and the sum of scores (or mean of the completed items, in the event of an incomplete scale) gets converted into a score from 0 (worst) to 100 (best).
Time frame: 14 weeks
Plan to share: No
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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LycoRed Ltd.