A Clinical Study to Assess the Safety and Effectiveness of Plant-based Biotin and Plant Based Bio… (NCT05972512) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Assess the Safety and Effectiveness of Plant-based Biotin and Plant Based Biotin with Silica in Healthy Human Subjects with Complaints of Hair Fall, Thin, Dry, & Brittle Hair, and Dry Skin
India105 participantsStarted 2023-08-22
Plain-language summary
A randomized, double-blind, three-arm, placebo-controlled, safety, and efficacy study of plant-based Biotin and plant-based Biotin with Silica in healthy adult human subjects with complaints of hair fall, thin, dry, and brittle hair, and dry skin.
A sufficient number (maximum of 105 (35 subject/test treatment)) of female/male adult subjects will be recruited/enrolled to ensure a total of 96 subjects (32 subjects/test treatment) complete the study.
Who can participate
Age range
20 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
. Age: 20 to 60 years (both inclusive) at the time of consent
. Sex: Healthy males and non-pregnant/non-lactating females.
. Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.
. Females of childbearing potential must have a reported negative pregnancy test.
. Subject are generally in good health.
. Subject must have negative Hepatitis B Surface Antigen Test at baseline.
. Subject with self-proclaimed nonpathological thin, dry and brittle hair.
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 in hair fall
Timeframe: Baseline (Day 01) before dosing to Day 30, Day 60, Day 90 post-dose, between treatments, within treatment and compare with placebo arm
2
Change in hair thickness (Unit= µm)
Timeframe: From baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
3
Change in hair growth rate (Unit= µm)
Timeframe: From screening (Within 4 Day) to Day 01, Day 27, Day 30, Day 57, Day 60, Day 87 and Day 90 post-dose, between treatment, within treatment, and compare with placebo arm
4
Change in PGA score for sign of brittle nails
Timeframe: Baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
5
Change in Hair Density (Unit= sqcm)
Timeframe: rom baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
6
Change in PGA score for sign of Nail Surface Roughness
Timeframe: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
. Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
Exclusion criteria
. Subjects with a history of hair thinning/hair fall due to any clinically significant self-reported problems/s like anaemia, thyroid problems, etc.
. Subject has a history of allergy or sensitivity to the test treatment ingredients.
. Subject has a history of any dermatological condition of the scalp other than hair loss and/or dandruff or active dermatological condition that might interfere with the clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).
. Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
. Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
. Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
. Subject is currently pregnant/breastfeeding.
. Subject has a history of prior use of hair growth treatment within 3 months.
7
Change in PGA score for sign of Surface Raggedness
Timeframe: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
8
Change in PGA score for sign of Peeling
Timeframe: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm