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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline of the percentage of hair in anagen phase