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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
105
Mode of usage: Two times a day Route of administration: Oral
Mode of usage: Two times a day Route of administration: Oral
Mode of usage: Two times a day Route of administration: Oral
NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat, India
Change in hair fall
To assess the effectiveness of test treatment in terms of change in hair fall by using 60-s hair comb test
Time frame: Baseline (Day 01) before dosing to Day 30, Day 60, Day 90 post-dose, between treatments, within treatment and compare with placebo arm
Change in hair thickness (Unit= µm)
To assess the effectiveness of test treatment in terms of change in hair thickness by CASALite Nova thorough Phototrichogram
Time frame: 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
Change in hair growth rate (Unit= µm)
To assess the effectiveness of test treatment in terms of change in hair growth rate by using CASALite Nova thorough Phototrichogram
Time frame: 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
Change in PGA score for sign of brittle nails
To assess the effectiveness of test treatment in terms of change in PGA score for sign of brittle nails by using 5-point scoring scale Where 0= None and 5= Severe
Time frame: 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
Change in Hair Density (Unit= sqcm)
o assess the effectiveness of test treatment in terms of change in hair density by using CASALite Nova thorough phototrichogram
Time frame: 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
Change in PGA score for sign of Nail Surface Roughness
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface roughness by using 3 point scoring scale Where 0= None, 3= Severe
Time frame: 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
Change in PGA score for sign of Surface Raggedness
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface raggedness by using 3 point scoring scale Where 0= None, 3= Severe
Time frame: 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
Change in PGA score for sign of Peeling
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface peeling by using 4 point scoring scale where 0= none, 3= severe
Time frame: 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
Change in facial wrinkle
To assess the effectiveness of test treatment in terms of change in facial wrinkles by using Visioscan VC 20plus (Instrumental Evaluation)
Time frame: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in fine lines of crow's feet area,
To assess the effectiveness of test treatment in terms of change in fine lines of crow's feet area by using Visioscan VC 20plus (Instrumental Evaluation)
Time frame: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in skin hydration
To assess the effectiveness of test treatment in terms of change in skin hydration by using MoistureMeterEpiD (Instrumental Evaluation)
Time frame: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in hair Strength
To assess the effectiveness of test treatment in terms of change in hair strength by using hair pull test
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in skin elasticity
To assess the effectiveness of test treatment in terms of change in skin elasticity by using Cutometer Dual MPA 580(Instrumental Evaluation)
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in PGA Score
To assess the effectiveness of test treatment in terms of change in PGA scores i.e. dryness, redness, fine lines, coarse wrinkle, laxity, roughness, and sallowness by using Griffith scale Where 0= No appearance and 9= Severe
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in barrier function of skin
To assess the effectiveness of test treatment in terms of change in barrier function of skin by using Tewameter TM Hex(Instrumental Evaluation)
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in general appearance of hair
To assess the effectiveness of test treatment in terms of change in general appearance of hair such as hair shininess, hair reflection, hair volume, hair density, hair plasticity, hair frizziness by dermatologist trained evaluator
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in Anagen: Telogen ratio
To assess the effectiveness of test treatment in terms of change in Anagen: Telogen ratio of hair by using hair pluck test
Time frame: From baseline (Day01) to Day 90 (+2Days), between treatments, within treatment and compare with placebo treated arm
Change in facial photographs(Left/Center/Right)
Change in facial photographs (Left/Center/Right) of the subject by using Nikol Digital Camera D3300
Time frame: From baseline before usage of test treatments on Day 01, and after usage of test treatments on Day 30, Day 60, Day 90
Treatment perception questionnaire
To assess the effectiveness of test treatment in terms of treatment perception by using 9 point hedonic scale
Time frame: From before dosing of test treatments to after usage of test treatments on Day 30, Day 60, Day 90
Change in Complete Blood Count
Safety of test treatment will be assessed in terms of difference in Complete Blood Count
Time frame: From Day 01 and Day 90
Change in silicon deposits on hair cuticle
To assess the effect of test treatments in terms of change silicon deposits on hair cuticle by using Scanning Electrone Microscope (8 subject/ test treatment)
Time frame: From baseline (Day01) before dosing to Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in Skin Texture
To assess the effectiveness of test treatment in terms of change in Skin texture by using Visioscan VC 20plus
Time frame: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in Total Serum Cholesterol
Safety of test treatment will be assessed in terms of difference in Total Serum Cholesterol level
Time frame: From Day 01 and Day 90
Change in Triglycerides
Safety of test treatment will be assessed in terms of difference in Triglycerides level
Time frame: From Day 01 and Day 90
Change in LDL level
Safety of test treatment will be assessed in terms of difference in LDL level
Time frame: From Day 01 and Day 90
Change in HDL level
Safety of test treatment will be assessed in terms of difference in HDL level
Time frame: From Day 01 and Day 90
Change in Random Glucose Level
Safety of test treatment will be assessed in terms of difference in Random Glucose Level
Time frame: From Day 01 and Day 90