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

NovoBliss Research

Status: Completed

Conditions: Dry Hair; Brittle Hair; Thin Hair; Hair Falling; Dry Skin

Treatments: Dietary Supplement: Botanical extract of standardised biotin with silica; Dietary Supplement: Botanical extract of standardized biotin; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05972512

NB230019-OI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The test treatment will be taken two times a day.

Treatment:

Other: Placebo

Botanical Extract of standardised for biotin (1250 mcg)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Botanical extract of standardized biotin

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Botanical extract of standardised biotin with silica