Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Orgenetics, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The test treatment will be taken two times a day. |
|
| Botanical Extract of standardised for biotin (1250 mcg) | Experimental | The standardised botanical extract of biotin is specially formulated for healthier hair and skin. Biotin promotes the hair growth. |
|
| Botanical Extract of standardised for biotin (1250mcg) + 10 mg Silica | Experimental | The standardised botanical extract of biotin and silica is specially formulated for healthier hair. The combination of biotin and silica will helpful in hair growth, reduces shedding, and improves the health of hair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Mode of usage: Two times a day Route of administration: Oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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, |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr Nayan K Patel | Medical Direcor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Pvt Ltd | Gandhinagar | Gujarat | 382421 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study
Not provided
Not provided
The study is double blind wherein neither the subjects nor the Investigator shall be aware of the test treatment allocation
| Botanical extract of standardized biotin |
| Dietary Supplement |
Mode of usage: Two times a day Route of administration: Oral |
|
| Botanical extract of standardised biotin with silica | Dietary Supplement | Mode of usage: Two times a day Route of administration: Oral |
|
| 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 |
| 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 | 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 | 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 |
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) |
| 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) | 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 | 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) | 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 | 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 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) | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | From Day 01 and Day 90 |
| Change in Triglycerides | Safety of test treatment will be assessed in terms of difference in Triglycerides level | From Day 01 and Day 90 |
| Change in LDL level | Safety of test treatment will be assessed in terms of difference in LDL level | From Day 01 and Day 90 |
| Change in HDL level | Safety of test treatment will be assessed in terms of difference in HDL level | 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 | From Day 01 and Day 90 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012822 | Silicon Dioxide |
| ID | Term |
|---|---|
| D008903 | Minerals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017655 | Silicon Compounds |
Not provided
Not provided