A Clinical Study to Assess the Safety and Effectiveness of Plant Based Biotin in Healthy Human Subjects With Thin, Dry, and Brittle Hair

Study Overview
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Brief Summary
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This is a randomized, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry, and brittle hair. a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.

Detailed Description
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This is a randomised, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry and brittle hair. a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study. total of 51 subjects was completed the study. The potential subjects were screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects were instructed to visit the facility as per the below visits. Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations Visit 02 (Day 28): Treatment Period, Evaluations Visit 03 (Day 56): Evaluations, End of Study Visit Subjects were pre-screened by the screening department of NovoBliss Research. Subjects were called on the telephone by the recruiting department prior to the enrolment visit. Subjects were told during screening (prior to enrolment) not to wear any facial make-up or use any hair product on the study visit day. Assessment of efficacy parameters before test treatment usage was done on day 1, and after test treatment usage was done on day 28, and day 56 as listed below. General Appearance of Hair i.e., hair volume, hair reflection, hair plasticity, hair density, hair smoothness, hair oiliness, hair shininess. General Appearance of Scalp i.e., Scalp itchiness, redness, scaling. CASLite Nova: Hair Density, Thickness, scalp condition Visioscan (C+K Instrument): Crow's feet area wrinkles, fine lines, skin texture - roughness, Skin Colorimeter CL 400: Right cheek skin colour evenness L*, a* b* and RGB, ITA Angle DermaLab®Combo - skin elasticity (Right cheek) MoitureMeterEPiD: Skin Hydration (Right cheek) Vapometer: Skin Barrier function - Transepidermal water loss (Right cheek) Physician Global Assessment for improvement in brittle nails - Day 01 and Day 56 Serum Ferratin Biomarker test (Day 1 as baseline and Day 56) Digital Photographs: Facial photographs Before test treatment usage and after test treatment usage. Subjective Product Perception Assessment regarding the test product's effect on hair and skin firmness, appearance, nails etc

Official Title
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A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy Study of Plant Based Biotin in Healthy Adult Human Subjects With Thin, Dry, and Brittle Hair

Conditions
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Hair Thinning, Hair Brittle, Dry Hair

Intervention / Treatment
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* Dietary Supplement: SesZen-Bio™
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 30 to 55 years (both inclusive) at the time of consent. Sex: Healthy males and non-pregnant/non-lactating females. Females of childbearing potential must have a self-reported negative pregnancy test. Subjects are generally in good health. Subject with self-proclaimed nonpathological thin, dry and brittle hair. Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale). Subject has a score of at least mild skin aging based on PGA at screening visit. Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator. 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. Subjects who have used other marketed products for hair thinning in the past. 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 product for the entire duration of the study. Willing to use test product throughout the study period Exclusion Criteria: Subjects with a history of hair thinning/hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc. Subject has a history of allergy or sensitivity to the test treatment ingredients like sesbania agati and others etc. 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. Subject who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion. 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 cosmetics, devices or therapeutic trials or hair/scalp/skin care products within the last four weeks.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SesZen-Bio™<br>SesZen-Bio™ is specially formulated for healthy hairs and healthy skin. Fortified with Sesbania Agati for 2X Hair Follicle Stimulation & Hair Fall Control, to Promote Shiny Hair, biotin that Supports Hair Growth. | Dietary Supplement: SesZen-Bio™<br>* mode of usage: 1 capsule in the morning and 1 capsule at night. administration: Oral Administration<br>|
| Placebo Comparator: Placebo (Tapioca based starch Capsules)<br>tapioca starch, is a starchy white flour that has a slight sweet flavor to it and is prepared by extrusion and coating process. | Other: Placebo<br>* Mode of Usage: 1 capsule in the morning and 1 capsule at night. Route of Administration: Oral Administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hair Density | To evaluate the effectiveness of test treatment in terms of change in hair density between the treatment and placebo group by using CasaLiteNova (Instrumental Reading) | Day 01,Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Hair Thickness | To evaluate the effectiveness of test treatment in terms of change in hair thickness between the treatment and placebo group by using CasaLiteNova (Instrumental Reading) | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Scalp Condition | To evaluate the effectiveness of test treatment in terms of change in scalp condition between the treatment and placebo group by using CasaLiteNova (Instrumental Reading) | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Facial Wrinkle | To evaluate the effectiveness of test treatment in terms of reducing facial wrinkle between the treatment and placebo group by using VisioScan (Instrumental Readings) | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Fine Lines | To evaluate the effectiveness of test treatment in terms of reducing fine lines between the treatment and placebo group by using VisioScan (Instrumental Readings) | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physician Global Assessment (PGA) scoring | To assess the effectiveness of test treatment in terms of change in Physician Global Assessment (PGA) between the treatment and placebo group by using Griffiths Scale 0 point= No appearance, 7-9point= Severe | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Glogau Skin Age | To assess the effectiveness of test treatment in terms of change in Glogau Skin Age between the treatment and placebo group by using Glogau Skin Age Classification | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Skin Colour | To assess the effectiveness of test treatment in terms of change in skin colour between the treatment and placebo group i.e.L* a* b* and ITA (Individual Topology Angle) using Skin-Colorimeter CL 400 (Instrumental Readings) | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Skin Elasticity | To assess the effectiveness of test treatment in terms of change in skin elasticity between the treatment and placebo group by using DermaLab Combo (Instrumental Reading) | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Skin Hydration | To assess the effectiveness of test treatment in terms of change in skin hydration between the treatment and placebo group by using MoistureMeterEpiD (Instrumental Reading) the result indicated in % | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Skin barrier Function | To assess the effectiveness of test treatment in terms of change in Skin Barrier Function between the treatment and placebo group by using Vapometer (Instrumental Reading) the result indicated in % | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in Serum Ferritin | To assess the effectiveness of test treatment in terms of change in serum ferritin between the treatment and placebo group | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Change in brittle nails | To assess the effectiveness of test treatment in terms of change in brittle nails between the treatment and placebo group by using Physician Global Assessment (PGA) 0=None, 5= Severe | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Noticeable Improvement in Facial Photograph | To assess the effectiveness of test treatment in terms of noticeable improvement in Facial Wrinkle between the treatment and placebo group by using Digital Camera (Visual Change) | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) | 
| Subjective Perception Questionnaires | To assess the effectiveness of test treatment in terms of Subjective perception on color, fragrance, taste, skin hydration, skin tone, firmness, appearance, hair and nails strongness and shine between the treatment and placebo group by using 9 point Hedonic scale | Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days) |