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 range20 Years – 60 Years
SexALL
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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.
✓. 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.
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 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.
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