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
Sponsor study identifier
interventional
54
1 country
1
Study Start
October 31, 2022
Actual (reported)Primary Completion
December 13, 2022
Actual (reported)Study Completion
January 10, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 10, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2022
Actual (reported)December 13, 2022
Actual (reported)January 10, 2023
Actual (reported)February 25, 2023
Actual (reported)April 5, 2023
Actual (reported)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)
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)
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.
tapioca starch, is a starchy white flour that has a slight sweet flavor to it and is prepared by extrusion and coating process.
mode of usage: 1 capsule in the morning and 1 capsule at night. administration: Oral Administration
Mode of Usage: 1 capsule in the morning and 1 capsule at night. Route of Administration: Oral Administration
NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat, India
Dr. Nayan K Patel, MBBS
Medical Director
54 participants (actual enrollment reported by the registry).
First Submitted
February 25, 2023
Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Posted
April 5, 2023
Study Start
October 31, 2022
Actual (reported)Primary Completion
December 13, 2022
Actual (reported)Study Completion
January 10, 2023
Actual (reported)Last Updated
April 5, 2023
Record last verified: 2023-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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