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

NCT05800496 | Completed

• 1 other identifier: NB220024-FC
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hair Thinning; Hair Brittle; Dry Hair

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Change in Physician Global Assessment (PGA) scoring

  Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)

• Change in Glogau Skin Age

  Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)

• Change in Skin Colour

  Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)

• Change in Skin Elasticity

  Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)

• Change in Skin Hydration

  Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)

Study Arms (2)

SesZen-Bio™

EXPERIMENTAL

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™

Placebo (Tapioca based starch Capsules)

PLACEBO COMPARATOR

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

Interventions

SesZen-Bio™ DIETARY_SUPPLEMENT

mode of usage: 1 capsule in the morning and 1 capsule at night. administration: Oral Administration

SesZen-Bio™

Placebo OTHER

Mode of Usage: 1 capsule in the morning and 1 capsule at night. Route of Administration: Oral Administration

Placebo (Tapioca based starch Capsules)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant or breastfeeding or planning to become pregnant during the study period.
• History of chronic illness which may influence the cutaneous state.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• ZYWIE VENTURES PRIVATE LIMITED: collaborator

Study Sites (1)

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, India

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Nayan K Patel, MBBS

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects were randomly assigned in a 1:1 ratio to receive either treatment A or Placebo. The randomization code was generated by NovoBliss Research. Subjects were randomly allocated to one of the treatment groups, as per the randomization code. Complete double-blinding was kept wherein neither the subjects nor the investigator was aware of the test treatment allocation. To maintain double blinding, the study staff who involves in treatment dispensing and distribution was not involved in any other study-related activities.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator-Medical Director

Model Details: A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: April 5, 2023
• Study Start: October 31, 2022
• Primary Completion: December 13, 2022
• Study Completion: January 10, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)