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CompletedNCT05972512Updated Mar 3, 2025

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

An interventional study of Placebo and Botanical extract of standardized biotin in Hair Falling, Thin Hair and Dry Hair, sponsored by NovoBliss Research Pvt Ltd. Completed at 1 site in India. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hair Falling
  • Thin Hair
  • Dry Hair
  • Brittle Hair
  • Dry Skin
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 105 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

NovoBliss Research Pvt Ltd is the lead sponsor of 45 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age: 20 to 60 years (both inclusive) at the time of consent
  2. Sex: Healthy males and non-pregnant/non-lactating females.
  3. Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.
  4. Females of childbearing potential must have a reported negative pregnancy test.
  5. Subject are generally in good health.
  6. Subject must have negative Hepatitis B Surface Antigen Test at baseline.
  7. Subject with self-proclaimed nonpathological thin, dry and brittle hair.
  8. Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
  9. Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
  10. Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
  11. Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
  12. If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
  13. If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
  14. Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
  15. Subjects are willing to give written informed consent and are willing to follow the study procedure.
  16. Subjects who have used other marketed products for hair thinning in the past.
  17. Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test treatments for the entire duration of the study.
  18. Willing to use test treatments throughout the study period.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with a history of hair thinning/hair fall due to any clinically significant self-reported problems/s like anaemia, thyroid problems, etc.
  2. Subject has a history of allergy or sensitivity to the test treatment ingredients.
  3. 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.).
  4. 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.
  5. Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
  6. Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
  7. Subject is currently pregnant/breastfeeding.
  8. Subject has a history of prior use of hair growth treatment within 3 months.
  9. Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
  10. Subject has a history of alcohol or drug addiction.
  11. Subjects who have plans of shaving scalp hair during the study.
  12. Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease.
  13. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
  14. Pregnant or breastfeeding or planning to become pregnant during the study period.
  15. History of chronic illness which may influence the cutaneous state.
  16. Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or hair/scalp/skin care products within the last four weeks.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
105 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    The test treatment will be taken two times a day.

    Other: Placebo

  • Experimental
    Botanical Extract of standardised for biotin (1250 mcg)

    The standardised botanical extract of biotin is specially formulated for healthier hair and skin. Biotin promotes the hair growth.

    Dietary Supplement: Botanical extract of standardized biotin

  • Experimental
    Botanical Extract of standardised for biotin (1250mcg) + 10 mg Silica

    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.

    Dietary Supplement: Botanical extract of standardised biotin with silica

Interventions

  • OtherPlacebo

    Mode of usage: Two times a day Route of administration: Oral

  • Dietary supplementBotanical extract of standardized biotin

    Mode of usage: Two times a day Route of administration: Oral

  • Dietary supplementBotanical extract of standardised biotin with silica

    Mode of usage: Two times a day Route of administration: Oral

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

07

Study locations

1 site
  • NovoBliss Research Pvt Ltd
    Gandhinagar, Gujarat 382421, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05972512
Lead sponsor
NovoBliss Research Pvt Ltd
Collaborators
Orgenetics, Inc.
Responsible party
Dr Nayan Patel (Principal Investigator- Medical Director, NovoBliss Research Pvt Ltd) — Principal investigator
First posted
Aug 2, 2023
Start date
Aug 22, 2023
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023
Last update
Mar 3, 2025

Study contacts

Dr Nayan K Patel
principal investigator · Medical Direcor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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