SesZenBio™ - Clinical Research Data Summary

SesZenBio™ Sesbania grandiflora Extract (Plant-Derived Biotin)

SesZenBio™ is a clinically studied ingredient that will be used in an upcoming Silver Fern™ Brand product.

Introduction

SesZenBio™ is a clinically studied Ayurvedic botanical derived from Sesbania grandiflora, a plant traditionally used in herbal practices and standardized to naturally occurring plant-derived biotin. Unlike typical biotin supplements, SesZenBio™ has been studied for its ability to support multiple biological pathways associated with healthy hair biology. Research suggests it may help support normal iron utilization and keratin production — two nutritional factors that play important roles in maintaining healthy hair structure and appearance.

Preclinical research also indicates it may influence the Wnt/β-catenin signaling pathway, a biological pathway involved in the normal hair follicle cycle and cellular activity within the follicle. Through these mechanisms, SesZenBio™ helps support the natural hair growth cycle and overall hair health, making it a scientifically researched botanical ingredient for individuals looking to support healthy hair thickness and appearance.*

These are the studies for SesZenBio™. Below, we provided a summary of each key data for each study, along with a link to the complete clinical research.

Summary of Study 1 – Full Study: https://www.ijclinicaltrials.com/index.php/ijct/article/view/782
Summary of Study 2 – Full Study: https://globalresearchonline.net/ijpsrr/v85-4/28.pdf

Ingredient Manufacturer Link: https://www.zenherblabs.com/products/clinicallyBackend/SesZen

Study 1 Summary

Complete Study Information: https://www.ijclinicaltrials.com/index.php/ijct/article/view/782

A Prospective, Randomized Double-Blind, Placebo-Controlled Study for Safety and Efficacy of SesZen-Bio™: A Proprietary Sesbania grandiflora Extract in Supporting Hair and Scalp Health in Healthy Adults
Upadhyay R. et al. Int J Clin Trials. 2024;11(2):124–131.

This prospective, randomized, double-blind, placebo-controlled clinical trial evaluated the safety and efficacy of SesZen-Bio™ (250 mg Sesbania grandiflora extract standardized to 0.5% biotin, one capsule morning and night) in 51 completing participants (25 test, 26 placebo) aged 30–55 years with thin, dry, brittle hair and visible hair thinning over 56 days.

Study Design Highlights

Study design: Prospective, randomized, double-blind, placebo-controlled
Participants: 54 enrolled, 51 completed (ages 30–55, mean ~39 years)
Dose: 250 mg SesZen-Bio™ (0.5% biotin) twice daily vs. tapioca starch placebo
Duration: 56 days
Primary outcomes: Hair density (CASLite-Nova phototrichogram), hair thickness
Secondary outcomes: Serum ferritin, visual scalp appearance, self-assessment questionnaires

Key Findings (What the Study Showed)

1. Significant Increase in Hair Density

Treatment group: +58.92 ± 28.69 hairs/cm² by Day 56 (~25% increase from baseline)
Placebo showed minimal change
Statistically significant difference between groups (p < 0.0001)

2. Significant Increase in Hair Thickness

Treatment group: +3.68 ± 2.69 μm (~16.94% increase from baseline)
Significantly greater than placebo (p = 0.0064)

3. Improvement in Overall Hair Appearance

~72% of treatment participants reported overall improvement in hair appearance vs. 3.85% placebo
60% reported noticing less hair shedding vs. 15.38% placebo
64% reported the appearance of thicker hair vs. 11.54% placebo
Visual improvements in hair volume, density, shininess, smoothness, and reduction in scalp dryness

4. Increase in Serum Ferritin

Serum ferritin levels increased by 27% in the treatment group
Iron status plays an important role in normal hair follicle biology and hair appearance

5. Safety and Tolerability

No adverse events reported
No serious adverse events occurred
Well tolerated throughout the 56-day study period

Benefits of SesZenBio™ Demonstrated by This Study

Based directly on the clinical outcomes, SesZenBio™ was shown to:
✓ Support ~25% increase in hair density within 8 weeks (p < 0.0001)
✓ Support ~17% increase in hair shaft thickness (p = 0.0064)
✓ Support improvements in visual hair quality and scalp appearance in ~72% of participants
✓ Support reduced perceived hair shedding in 60% of participants vs. 15% placebo
✓ Support a 27% increase in serum ferritin levels
✓ Be safe and well tolerated with no adverse events

Why This Study Matters

This research provides randomized, placebo-controlled human data evaluating a plant-based ingredient for supporting healthy hair and scalp biology. The use of objective CASLite-Nova phototrichogram technology to measure hair density adds rigor to the findings, and the statistically significant improvements in both density and thickness within 56 days make this a strong clinical evidence base for SesZenBio™.*

Reference Link: https://www.ijclinicaltrials.com/index.php/ijct/article/view/782

Study 2 Summary

Complete Study Information: https://globalresearchonline.net/ijpsrr/v85-4/28.pdf

SesZen-Bio™: A Novel Modulator of Wnt/β-Catenin Signaling Associated with Hair Follicle Biology
Upadhyay R. et al. Int J Pharm Sci Rev Res. 2025;85(4):197–203.

This in vitro and ex vivo mechanistic study investigated the biological activity of SesZen-Bio™ on outer root sheath cells (ORSCs), dermal papilla cells (DPCs), stem cell markers, and Wnt/β-catenin signaling using human hair follicle models.

Study Design Highlights

Study type: In vitro and ex vivo mechanistic study
Cell models: Human Outer Root Sheath Cells (ORSCs) and Human Dermal Papilla Cells (DPCs)
Concentrations: 10 µg/ml and 50 µg/ml SesZen-Bio™
Assays: MTT cell viability, ATP luminescence, RT-PCR gene expression, ex vivo hair follicle organ culture (Philpott model)
Comparators: 1% Minoxidil (ex vivo reference), EGF and bFGF (positive controls in cell assays)

Key Findings (What the Study Showed)

1. Increased ORSC Cellular Activity

10 µg/ml: ORSC viability increased to 187.8% of control
50 µg/ml: ORSC viability increased to 261.8% of control
Effects comparable to or greater than the EGF positive control
Bcl2 expression (cellular survival marker): increased 23.4-fold (10 µg/ml) and 18.9-fold (50 µg/ml)

2. Enhanced Metabolic Activity in Dermal Papilla Cells

10 µg/ml: ATP production increased to 177% of control (greater than bFGF control at 114%)
50 µg/ml: No significant ATP increase observed (suggesting concentration-dependent activity)

3. Modulation of Wnt/β-Catenin Signaling Pathway

Wnt10b: increased 2.0-fold (10 µg/ml) and 2.3-fold (50 µg/ml)
β-catenin: increased 1.6-fold (10 µg/ml) and 2.4-fold (50 µg/ml)
Lef1 expression: not significantly altered
The Wnt/β-catenin pathway plays a role in normal hair follicle cycling and cellular communication

4. Increased Stem Cell Marker Expression

CK15 (follicular stem cell marker): increased up to 3.69-fold (50 µg/ml)
Sox9 (follicular stem cell marker): increased 2.83-fold (10 µg/ml)

5. Increased Hair Shaft Length in Ex Vivo Model

Using an ex vivo human hair follicle organ culture model over 10 days:

Control: 21.8 µm growth
1% Minoxidil reference: 36.4 µm growth (+66.9% vs. control)
0.8% SesZen-Bio™: 41.4 µm growth (+89.9% vs. control)

Benefits of SesZenBio™ Demonstrated by This Study

Based directly on the mechanistic and ex vivo data, SesZenBio™ was shown to:
✓ Support ORSC cellular viability to 187–262% of control
✓ Support Bcl2 cellular survival marker expression up to 23-fold
✓ Support DPC metabolic activity (ATP) to 177% of control at 10 µg/ml
✓ Modulate Wnt/β-catenin pathway markers (Wnt10b, β-catenin) in a dose-dependent manner
✓ Support follicular stem cell marker expression (CK15 up to 3.69-fold, Sox9 up to 2.83-fold)
✓ Support 89.9% increase in hair shaft elongation in ex vivo model vs. 66.9% for 1% Minoxidil reference

Why This Study Matters

This mechanistic research provides insight into how SesZenBio™ interacts with multiple biological pathways associated with hair follicle function, including Wnt/β-catenin signaling and markers associated with follicular stem cell populations. These findings complement the human clinical data from Study 1, providing a biological explanation for the improvements in hair density and thickness observed clinically.*

Reference Link: https://globalresearchonline.net/ijpsrr/v85-4/28.pdf

Big-Picture Integration with Other Studies

Study 1: In a double-blind, placebo-controlled human trial (n=51), SesZenBio™ at 500 mg/day for 56 days was associated with ~25% increase in hair density (p < 0.0001), ~17% increase in hair thickness (p = 0.0064), 27% increase in serum ferritin, and improvements in hair appearance in ~72% of participants — with no adverse events.
Study 2: In vitro and ex vivo mechanistic research demonstrated that SesZenBio™ modulates Wnt/β-catenin signaling markers, increases follicular stem cell–associated markers (CK15, Sox9), supports ORSC cellular viability, and increased hair shaft elongation by 89.9% in an ex vivo model — exceeding the 66.9% observed with 1% Minoxidil reference.

Together, these studies support SesZenBio™ as a clinically researched, plant-derived ingredient with both human clinical data and laboratory research exploring its underlying biological activity related to healthy hair and scalp biology.*

SesZenBio™ Ingredient Summary & Real-World Relevance

SesZenBio™ is a plant-derived ingredient from Sesbania grandiflora standardized to 0.5% naturally occurring biotin. Unlike typical biotin supplements that deliver isolated nutrients, SesZenBio™ has been studied for its ability to support multiple biological pathways associated with healthy hair and scalp biology.

In a double-blind, placebo-controlled human study, supplementation with SesZenBio™ was associated with improvements in hair density and thickness over 56 days, with no adverse events reported.* Laboratory research also suggests the ingredient interacts with biological pathways involved in normal hair follicle function, including Wnt/β-catenin signaling and markers associated with follicular stem cells.

Together, these findings suggest SesZenBio™ may help support the natural hair cycle, hair structure, and overall hair appearance. As a standardized botanical extract, it offers a well-tolerated option for individuals seeking nutritional support for healthy hair density, thickness, and scalp health.*

Ingredient Manufacturer Link: https://www.zenherblabs.com/products/clinicallyBackend/SesZen

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.