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

NCT05972512 | Completed

• 1 other identifier: NB230019-OI
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hair Falling; Thin Hair; Dry Hair; Brittle Hair; Dry Skin

Outcome Measures

Primary Outcomes (8)

• 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

• 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

Secondary Outcomes (19)

• Change in facial wrinkle

  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,

  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

  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

  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

  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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The test treatment will be taken two times a day.

Other: Placebo

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.

Dietary Supplement: Botanical extract of standardized biotin

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.

Dietary Supplement: Botanical extract of standardised biotin with silica

Interventions

Placebo OTHER

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

Placebo

Botanical extract of standardized biotin DIETARY_SUPPLEMENT

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

Botanical Extract of standardised for biotin (1250 mcg)

Botanical extract of standardised biotin with silica DIETARY_SUPPLEMENT

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

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

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
• Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
• 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.
• 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.
• Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
• Subjects are willing to give written informed consent and are willing to follow the study procedure.

You may not qualify if:

• Subjects with a history of hair thinning/hair fall due to any clinically significant self-reported problems/s like anaemia, thyroid problems, etc.
• 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.
• Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
• Subject has a history of alcohol or drug addiction.
• Subjects who have plans of shaving scalp hair during the study.
• Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease.
• Pregnant or breastfeeding or planning to become pregnant during the study period.
• History of chronic illness which may influence the cutaneous state.
• Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or hair/scalp/skin care products within the last four weeks.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Orgenetics, Inc.: collaborator

Study Sites (1)

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, 382421, India

Location

MeSH Terms

Conditions

Alopecia

Interventions

Silicon Dioxide

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Minerals; Inorganic Chemicals; Oxides; Oxygen Compounds; Silicon Compounds

Study Officials

• Dr Nayan K Patel

  Medical Direcor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study is double blind wherein neither the subjects nor the Investigator shall be aware of the test treatment allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator- Medical Director

Model Details: A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 2, 2023
• Study Start: August 22, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: March 3, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)