NCT05972512

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

A Randomized, Double-Blind, 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, & Brittle Hair, and Dry Skin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Total study visits will be 8 during this study. Visit 01 (Within 30 Days): Screening procedure, Informed consent obtain process, baseline evaluations, blood collection, tattoo on scalp, hair growth rate measurement Visit 02 (Day 01): Enrolments, hair growth rate measurement, other evaluations, product distribution, diary distribution, AE reporting (if any. Visit 03 (Day 27 +2 Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE reporting (if any). Visit 04 (3 Days from Visit 03): Treatment period, evaluations, diary card review, AE Reporting (if any). Visit 05 (Day 57 + 2Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE Reporting (if any). Visit 06 (3 Days from Visit 05): Treatment period, evaluations, diary card review, AE Reporting (if any). Visit 07 (Day 87 +2 Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE Reporting (if any). Visit 08 (3 days from Visit 08): Evaluations, dairy card collection, AE reporting, test treatments accountability, End of Study process. done on Day 04 before Day 01, Day 01 and after test treatment usage will be done on Day 27, Day 30, Day 57, Day 60, Day 87, Day 90 as listed-below. * 60-S Hair Combing Method: Hair Fall. * CASALite Nova (Phototrichogram): Hair Density, Thickness, Hair Growth Rate, Scalp Condition. * PGA Score: Signs of brittle nails, surface roughness, raggedness and peeling. * Visioscan®VC 20plus (C+K Instrument): Crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness (Right cheek). * MoitureMeterEPiD: Skin hydration (Right cheek). * Hair Pull Test: Hair strength. * Pluck Test: A:T ratio (Hair Growth Cycle) * Cutometer: Skin elasticity (Right cheek). * PGA Griffith Scale: Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness * Tewameter® TM 300: Skin barrier function (Right Cheek) * General Appearance of Hair: Hair shininess, hair reflection, hair plasticity, hair fizziness, hair volume, hair density Digital photographs: Facial photographs before test treatment consumption and after test treatment consumption * Blood parameters: CBC, total Serum Cholesterol, Triglyceride, Random Glucose, LDL, HDL \[Note: blood collection will be performed on Day 01 And Day 90\] * Blood parameter: HBsAg (Hepatitis B surface antigen) - Screening only * Subjective product perception assessment regarding the test treatment's effect on skin elasticity, suppleness, skin color, fragrance, taste, skin hydration, skin tone, firmness, appearance, hair and nails, strongness and shine.

Conditions

• Hair Falling
• Thin Hair
• Dry Hair
• Brittle Hair
• Dry Skin

Interventions

Type	Name	Description
OTHER	Placebo	Mode of usage: Two times a day Route of administration: Oral
DIETARY_SUPPLEMENT	Botanical extract of standardized biotin	Mode of usage: Two times a day Route of administration: Oral
DIETARY_SUPPLEMENT	Botanical extract of standardised biotin with silica	Mode of usage: Two times a day Route of administration: Oral

Timeline

• Start date: 2023-08-22
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2023-08-02
• Last updated: 2025-03-03

Locations

1 site across 1 country: India