A Clinical Study to Assess the Safety and Effectiveness of Plant Based Biotin in Healthy Human Su… (NCT05800496) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Assess the Safety and Effectiveness of Plant Based Biotin in Healthy Human Subjects With Thin, Dry, and Brittle Hair
India54 participantsStarted 2022-10-31
Plain-language summary
This is a randomized, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry, and brittle hair.
a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.
Who can participate
Age range
30 Years – 55 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: 30 to 55 years (both inclusive) at the time of consent.
. Sex: Healthy males and non-pregnant/non-lactating females.
. Females of childbearing potential must have a self-reported negative pregnancy test.
. Subjects are generally in good health.
. Subject with self-proclaimed nonpathological thin, dry and brittle hair.
. Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
. Subject has a score of at least "mild skin aging" based on PGA at screening visit.
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 Density
Timeframe: Day 01,Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
2
Change in Hair Thickness
Timeframe: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
3
Change in Scalp Condition
Timeframe: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
4
Change in Facial Wrinkle
Timeframe: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
5
Change in Fine Lines
Timeframe: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
. Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
Exclusion criteria
. Subjects with a history of hair thinning/hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc.
. Subject has a history of allergy or sensitivity to the test treatment ingredients like sesbania agati and others etc.
. 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.