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 range30 Years – 55 Years
SexALL
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.
✓. 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.
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)