Clinical trial NCT05972512: 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
Official title: A Randomized, Double-Blind, 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, & Brittle Hair, and Dry Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Falling
Thin Hair
Dry Hair
Brittle Hair
Dry Skin
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Orgenetics, Inc.
First posted: 2023-08-02
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in hair fall
timeFrame: Baseline (Day 01) before dosing to Day 30, Day 60, Day 90 post-dose, between treatments, within treatment and compare with placebo arm
measure: Change in hair thickness (Unit= µm)
timeFrame: 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
measure: Change in hair growth rate (Unit= µm)
timeFrame: 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
measure: Change in PGA score for sign of brittle nails
timeFrame: 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
measure: Change in Hair Density (Unit= sqcm)
timeFrame: 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: Change in PGA score for sign of Nail Surface Roughness
timeFrame: 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
measure: Change in PGA score for sign of Surface Raggedness
timeFrame: 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
measure: Change in PGA score for sign of Peeling
timeFrame: 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:
measure: Change in facial wrinkle
timeFrame: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
measure: Change in fine lines of crow's feet area,
timeFrame: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
measure: Change in skin hydration
timeFrame: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
measure: Change in hair Strength
timeFrame: 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
measure: Change in skin elasticity
timeFrame: 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
measure: Change in PGA Score
timeFrame: 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
measure: Change in barrier function of skin
timeFrame: 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
measure: Change in general appearance of hair
timeFrame: 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
measure: Change in Anagen: Telogen ratio
timeFrame: From baseline (Day01) to Day 90 (+2Days), between treatments, within treatment and compare with placebo treated arm
measure: Change in facial photographs(Left/Center/Right)
timeFrame: From baseline before usage of test treatments on Day 01, and after usage of test treatments on Day 30, Day 60, Day 90
measure: Treatment perception questionnaire
timeFrame: From before dosing of test treatments to after usage of test treatments on Day 30, Day 60, Day 90
measure: Change in Complete Blood Count
timeFrame: From Day 01 and Day 90
measure: Change in silicon deposits on hair cuticle
timeFrame: From baseline (Day01) before dosing to Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
measure: Change in Skin Texture
timeFrame: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
measure: Change in Total Serum Cholesterol
timeFrame: From Day 01 and Day 90
measure: Change in Triglycerides
timeFrame: From Day 01 and Day 90
measure: Change in LDL level
timeFrame: From Day 01 and Day 90
measure: Change in HDL level
timeFrame: From Day 01 and Day 90
measure: Change in Random Glucose Level
timeFrame: From Day 01 and Day 90
Other outcomes:
Locations:
city: Gandhinagar
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
affiliation: Medical Direcor
name: Dr Nayan K Patel
role: PRINCIPAL_INVESTIGATOR
References: