Study: Beer C, Wood S, Veghte RH. A clinical trial to investigate the effect of Cynatine HNS on hair and nail parameters. ScientificWorldJournal. 2014;2014:641723. doi: 10.1155/2014/641723. Epub 2014 Oct 16. PMID: 25386609; PMCID: PMC4214097. 

• Total participants: 50 women 
• Age range: 40 to 71 years 
• Groups: 25 in treatment group, 25 in placebo 
• Duration: 90 days 
• Design: Randomized, double-blind, placebo-controlled 
• Location: Italy 
• Criteria: Subjects with signs of damaged hair or nails (e.g., brittle nails, hair loss) 
• Peer-Reviewed: Yes 

Study Summary: The Beer et al. study was a randomized, double-blind, placebo-controlled clinical trial—considered the gold standard in clinical research. It involved 50 female participants aged 40 to 71, randomly assigned to receive either a bioavailable keratin peptide supplement, or a placebo daily for 90 days. The study included both objective trichological measurements and subjective self-assessments, enhancing its reliability. 

Results Compared to Placebo: The supplement group showed statistically significant improvements across several key hair parameters compared to placebo: 

• Reduction in Hair Loss (Brushing Test): 46.6% reduction in the keratin peptides group, 0.7% reduction in the placebo group, p-value < 0.001
• Increase in Hair Strength: 5.9% increase in the keratin peptides group, 0.8% increase in the placebo group, p-value < 0.005
• Increase in Anagen Phase Hairs: 9.2% increase in the keratin peptides group, 2.2% decrease in the placebo group, p-value < 0.01
• Improved Hair Appearance (Self-Assessment): over 95% reported improvement in the keratin peptides group, under 10% reported improvement in the placebo group, p-value < 0.01

Results:The results suggest that ingestible bioactive keratin peptides can meaningfully improve hair retention, strength, appearance, and growth cycle support within 90 days. The statistically significant differences from placebo highlight the active role of keratin peptides in follicle function and structural reinforcement. These findings support the use of keratin-based nutraceuticals as an effective non-drug option for those experiencing hair thinning, aging-related hair changes, or breakage.

Study: Kelly R, et al. Effect of keraGEN IV Keratin oral supplementation on hair, skin, and nail attributes. HealthMED. 2024, Vol 18, Num 2. 

• Total participants: 50 women 
• Age range: 40 to 71 years 
• Groups: 25 in treatment group, 25 in placebo 
• Duration: 90 days 
• Design: Randomized, double-blind, placebo-controlled 
• Location: France 
• Criteria: Healthy adult women concerned about the quality of hair, skin, and nails 
• Peer-Reviewed: Yes 

Study Summary: The study by Kelly et al. was a randomized, double-blind, placebo-controlled trial evaluating the effects of oral bioactive keratin peptides on hair, skin, and nails. Fifty healthy women aged 40–71 were enrolled and received either the active supplement or a placebo for 90 days. The study was well-designed with appropriate randomization and blinding procedures, a placebo control group, and multiple endpoints assessed through dermatologist evaluation, instrumental methods, and participant self-assessment. Compliance was high (>95%), and no adverse events were reported. 

Results Compared to Placebo: The supplement group showed statistically significant improvements across several key hair parameters compared to placebo: 

• Decrease in Hair Shedding: 47.1% decrease in the keratin peptides group, 3.5% decrease in the placebo group (not significant), p < 0.001
• Increase in Hair Strength: 16.9% increase in the keratin peptides group, 1.1% increase in the placebo group (not significant), p < 0.001
• Improved Hair Appearance: 90.9% reported improvement in the keratin peptides group, 18.2% reported improvement in the placebo group, p < 0.01
• Increase in Hair Volume: 15.3% increase in the keratin peptides group, 0.7% increase in the placebo group (not significant), p < 0.001
• Increase in Gloss/Shine: 59.2% increase in the keratin peptides group, 3.5% increase in the placebo group (not significant), p < 0.001
• Increase in Hair Density (TrichoScan): 9.6% increase in the keratin peptides group, 1.5% increase in the placebo group (not significant), p < 0.001
• Increase in Hair Diameter (TrichoScan): 9.1% increase in the keratin peptides group, 0.5% increase in the placebo group (not significant), p < 0.001

Results: The study demonstrated that oral supplementation with ingestible bioavailable keratin peptides leads to significant improvements in hair health, particularly in reducing hair loss and improving hair strength. The magnitude of change, such as a 46.6% decrease in shedding, is clinically meaningful and suggests that bioavailable keratin peptides can support follicle integrity. The high satisfaction rates in self-assessment (over 90%) reinforce the instrumental findings and highlight the perceived benefits. The absence of reported side effects and high compliance also support a favorable safety profile. These results provide substantiation for claims related to reduced shedding, stronger hair, and improved hair quality over 90 days. 

Study: Roddick-Lanzilotta A.D., Kelly R.J., et al. Keratin blend anchors follicles and prevents pollution induced hair fall. Cosmetics & Toiletries. Vol 134, No. 9. Pg 24-36. Oct 2019.  

Ex-Vivo Study Summary: The objective was to investigate the efficacy of a topical keratin peptide blend in anchoring hair follicles and protecting them from pollution-induced damage and hair fall, by increasing collagen IV expression in the scalp. 

Location and Oversight 

• Conducted in France 
• The explants and analysis were performed under controlled laboratory conditions using live human scalp tissue. 

Subjects and Sample Details 

• Donor: One 58-year-old woman undergoing a facelift procedure. 
• Samples: 16 live scalp explants were harvested from the donor. Each explant contained 2–3 viable hair follicles. 
• Explants were divided into 7 groups: Biopsy control, untreated control, two keratin-treated groups, pollution-only group, and two groups with keratin and pollution. 

Treatment Protocol 

• Keratin Peptide Blend: A combination of oxidized keratin, native keratin, and hydrolyzed keratin peptides was topically applied. 
• Pollution Exposure: Simulated urban pollutants and cigarette smoke. 
• Keratin peptides were applied on Days 0, 2, and 5. Pollution exposure occurred on Day 5. Tissue was harvested and analyzed on Day 6. 

Significant Results 

1. Collagen IV Expression 

• Keratin-treated explants showed a significant increase in collagen IV at the hair bulb and dermal papilla, especially with K1 formulation. 
• This increase strengthens the dermal-epidermal junction, improving hair follicle anchoring. 

2. Oxidative Stress Marker (Nrf2) 

• Nrf2 degradation is a marker of oxidative stress. Pollution significantly reduced Nrf2 levels. 
• Pre-treatment with keratin protected follicles from Nrf2 degradation, suggesting reduced oxidative stress. 

3. Cell Viability and Morphology 

• Pollution caused poor cell morphology, keratin degradation, and increased follicle separation (early signs of hair loss). 
• Keratin pre-treatment preserved cell structure and keratin expression, maintaining healthy follicular architecture. 

Mechanism of Action: Follicle Anchoring 

The authors propose a dual mechanism for follicle protection and anchoring: 

1. Structural Reinforcement via Collagen IV 

• Soluble keratin peptides stimulate keratinocytes to produce collagen IV, a critical protein of the basement membrane anchoring the follicle. 
• This strengthens the hair bulb’s connection to the scalp and improves resistance to hair fall. 
• Increased markers of follicle anchoring were observed at Day 6 

2. Antioxidant and Anti-inflammatory Support 

• The cysteine-rich profile of keratin enables: 
• Radical scavenging, neutralizing pollution-related oxidative damage. 
• Support for sulfur metabolism, enhancing glutathione and taurine production—key antioxidants in skin and follicle protection. 
• This biochemical support reduces inflammation and helps maintain keratinocyte health, preventing follicular degradation. 

In essence, the keratin peptides act both as a biological scaffold and a biochemical shield, reinforcing the follicle physically and protecting it metabolically.