Evaluation of Tolerance and Trichological Efficacy of a Food Supplement (NCT03272750) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Tolerance and Trichological Efficacy of a Food Supplement
51 participantsStarted 2016-11-04
Plain-language summary
Controlled, randomized, double blind study, for the evaluation of tolerance and trichological efficacy of a food supplement: Bioscalin® new formulation versus reference formulation currently on the market and placebo
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* both sexes;
* age range 18-60 years old;
* with telogen effluvium and a percentage of anagen ratio at inclusion \< 75%;
* no-smokers;
* accepting to follow the instruction received by the investigator;
* disposable and able to return to the study centre at the established times;
* accepting to not change their habits regarding food, physical activity, hair and scalp cleansing;
* accepting to not receive any drugs/cosmetics treatment able to interfere with the study results;
* no participation in a similar study actually or during the previous 6 months;
* accepting to sign the Informed consent form.
Exclusion Criteria:
* Pregnancy (for female subjects);
* lactation (for female subjects);
* subjects not in menopause who does not use adequate contraceptive precautions in order to avoid pregnancies during the study;
* subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, after 2 (T2) and 3 (T3) month-treatment;
* change in the normal habits regarding food, physical activity, physical activity, hair and scalp cleansing during the month preceding the test;
* sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit). The product contains gluten (aroma of grain), then all subjects with celiac disease or gluten intolerance should be excluded.
* subjects whose insufficient adhesion to the study protocol is foreseeable;
* participation in a similar study actually …
What they're measuring
1
Change from baseline of the percentage of hair in anagen phase