A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lumena… (NCT04356456) | Clinical Trial Compass
WithdrawnNot Applicable
A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lumenato and Its Impact on Skin Parameters in Healthy Female Subjects
Stopped: Covid-19
United States0Started 2020-01-14
Plain-language summary
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. cored Lumenato supplement on skin health and appearance.
Who can participate
Age range35 Years – 55 Years
SexFEMALE
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Inclusion criteria:
* Resides in the United States
* Generally healthy women between the ages of 35-55
* Fitzpatrick skin types 2 or 3
* Identifies as one of the following: White, Hispanic/Latino, or both White and Hispanic/Latino
* Type 2 on the Glogau Skin Classification scale
* Has expressed interest in improving skin health and appearance
* Willing and able to follow the procedures of the study
* Willing to refrain from changing their diet or lifestyle significantly for the duration of the study
* Able to understand the study requirements and activities in English, and provide informed consent
* Access to reliable internet service and smartphone in order to utilize the ClaimIt software/app needed to remotely participate in the study
Exclusion Criteria:
* Participants with Fitzpatrick skin types of 1, 4, 5 or 6
* Known allergies or sensitivity to tomato, latex and/or potato
* Current use or use within 1 month of study enrollment of hormonal therapies (including hormonal contraceptives)
* Current, regular use or regular use within 1 month of study enrollment of oral steroids; regular use defined as \>10 consecutive days
* Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias ("spider veins")
* Pregnant, lactating or breastfeeding women (within the last 6 months) or those planning to become pregnant during the study period
* Less than 2 years since diagnosis or treatment of skin …