keraGEN-IV® - Clinical Research Data Summary
keraGEN-IV® Solubilized Wool-Derived Keratin Protein
keraGEN-IV® is a clinically studied ingredient used in the following Silver Fern™ Brand products:
- Hair Complex – https://www.silverfernbrand.com/products/hair-complex
Introduction
keraGEN-IV® is a solubilized keratin protein derived from New Zealand wool that provides a concentrated source of sulfur-rich amino acids involved in supporting the structural proteins of hair, skin, and nails. Unlike traditional keratin, which is difficult to digest due to its insoluble structure, keraGEN-IV® is processed into a soluble form designed to improve bioavailability. These amino acids contribute to biological pathways associated with structural protein production, antioxidant activity, and connective tissue support.
Research on keratin proteins suggests they may help support collagen IV production and other structural proteins involved in maintaining the dermal-epidermal junction and hair follicle anchoring. Laboratory studies have demonstrated increased collagen IV expression in human skin cells exposed to keratin, while ex-vivo follicle research shows increased collagen deposition around the hair bulb. In a randomized, double-blind, placebo-controlled human study, daily supplementation with keraGEN-IV® for 60 days was associated with improvements in hair retention and skin structural markers in adults with stressed or damaged hair.*
These are the studies for keraGEN-IV®. 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://keraplast.com/brand/keragen-iv/
- Summary of Study 2 – Full Study: https://pubmed.ncbi.nlm.nih.gov/22621188/
- Summary of Study 3 – Full Study: https://www.cosmeticsandtoiletries.com/research/literature-data/article/21835607/keratin-blend-anchors-follicles-and-prevents-pollutioninduced-hair-fall
Ingredient Manufacturer Link: https://ingredients.aidp.com/#keragen-iv
Study 1 Summary
Complete Study Information: https://keraplast.com/brand/keragen-iv/
Randomized, Double-Blind, Placebo-Controlled Clinical Evaluation of keraGEN-IV® on Hair and Skin Parameters in Adults with Stressed Hair
Independent CRO study conducted by Laboratoire BIO-EC under the French Public Health Code.
A randomized, double-blind, placebo-controlled clinical study conducted by the independent laboratory Laboratoire BIO-EC evaluated the effects of oral keraGEN-IV® supplementation on hair and skin health in adults with damaged or stressed hair. Participants consumed 400 mg of keraGEN-IV® daily for 60 days, and outcomes were assessed at baseline, 30 days, and 60 days using dermatological assessments and objective measurements including hair-pull testing, skin elasticity, and transepidermal water loss (TEWL). Results demonstrated statistically significant improvements in hair retention and skin structural markers.
Study Design Highlights
- Study type: Randomized, double-blind, placebo-controlled human clinical trial
- Location: Laboratoire BIO-EC (France)
- Participants: Adults with damaged or stressed hair and healthy skin assessed by dermatologists
- Dose: 400 mg keraGEN-IV® per day
- Duration: 60 days
- Assessment points: Day 0, Day 30, Day 60
- Outcomes measured:
- Hair pull test (indicator of hair shedding and follicle anchoring)
- Skin elasticity (cutometry)
- Transepidermal water loss (TEWL), a marker of skin barrier integrity
Key Findings (What the Study Showed)
1. Hair Retention
- 43.1% reduction in hair shedding after 60 days compared with baseline
- Statistically significant improvement vs. placebo (p ≤ 0.005)
2. Skin Elasticity
- 10.1% improvement in skin elasticity by day 60
- Significant improvement compared with placebo (p ≤ 0.05)
3. Skin Barrier Function
- 12.5% reduction in transepidermal water loss (TEWL) by day 30
- Indicates improved skin barrier function and hydration retention
Benefits of keraGEN-IV® Demonstrated by This Study
Based directly on the clinical outcomes, keraGEN-IV® was shown to:
✓ Support a 43.1% reduction in hair shedding over 60 days
✓ Support a 10.1% improvement in skin elasticity
✓ Support a 12.5% reduction in TEWL (improved skin barrier function)
✓ Demonstrate statistically significant improvements vs. placebo in hair and skin markers
✓ Produce measurable skin barrier improvements by day 30
Why This Study Matters
This randomized controlled trial found that daily supplementation with keraGEN-IV® for 60 days significantly improved markers of hair retention and skin structural health compared with placebo. The observed reduction in hair shedding and improvements in skin elasticity and barrier integrity suggest keraGEN-IV® may support healthy hair follicle anchoring and skin structure when used consistently as part of a daily nutritional routine.*
Reference Link: https://keraplast.com/brand/keragen-iv/
Study 2 Summary
Complete Study Information: https://pubmed.ncbi.nlm.nih.gov/22621188/
Wool-Derived Keratin Stimulates Human Keratinocyte Migration and Types IV and VII Collagen Expression
Exp Dermatol. 2012 Jun;21(6):458-60. doi: 10.1111/j.1600-0625.2012.01505.x. PMID: 22621188.
An in-vitro laboratory study evaluated the effects of wool-derived keratin proteins on cultured human keratinocytes, the skin cells responsible for producing structural proteins in the skin and hair follicle. Researchers examined how the keratin protein influenced collagen production and cellular growth under normal and stress conditions.
Study Design Highlights
- Study type: In-vitro cellular study
- Cell model: Human keratinocytes (skin cells responsible for structural protein production)
- Intervention: Exposure to keraGEN-IV® keratin protein
- Purpose: Evaluate effects on collagen IV production and cell growth under stress conditions
Key Findings (What the Study Showed)
1. Collagen Production
Up to 3× increase in collagen IV expression in keratinocytes exposed to keraGEN-IV®. Collagen IV is a structural protein located at the dermal-epidermal junction, where it helps support skin structure and hair follicle anchoring.
2. Cellular Growth Under Stress
Keratinocyte cells exposed to keraGEN-IV® showed 35% faster cell growth under stress conditions compared with untreated cells.
Benefits of keraGEN-IV® Demonstrated by This Study
Based directly on the laboratory findings, keraGEN-IV® was shown to:
✓ Support up to 3× increase in collagen IV expression in human keratinocytes
✓ Support 35% faster keratinocyte cell growth under stress conditions
✓ Influence biological processes involved in maintaining structural proteins within skin and hair follicle environments
Why This Study Matters
Although this research was conducted in a laboratory cell model, the findings help explain potential mechanisms through which keraGEN-IV® supplementation may support hair and skin health. The observed increase in collagen IV expression may help explain the improvements in hair shedding and skin elasticity observed in human studies of keraGEN-IV®. Collagen IV supports structural integrity at the dermal-epidermal junction — the same region involved in follicle anchoring.*
Reference Link: https://pubmed.ncbi.nlm.nih.gov/22621188/
Study 3 Summary
Complete Study Information: https://www.cosmeticsandtoiletries.com/research/literature-data/article/21835607/keratin-blend-anchors-follicles-and-prevents-pollutioninduced-hair-fall
A Hold on Hair: Keratin Extracts Improve Follicle Anchoring and Prevent Pollution-Induced Hair Fall
Cosmetics & Toiletries. 134(9), 24–38.
An ex-vivo laboratory study evaluated the effects of keratin protein extracts on isolated human hair follicles. Hair follicle explants were exposed to keratin and examined using histological imaging to assess structural protein changes within the follicle environment. Researchers observed increased deposition of collagen IV at the follicle junction and structural thickening around the hair bulb after treatment.
Study Design Highlights
- Study type: Ex-vivo tissue model
- Model: Human hair follicle explants
- Intervention: Keratin protein treatment
- Analysis method: Histological microscopy to evaluate collagen deposition and follicle structure
- Treatment duration: 6 days
Key Findings (What the Study Showed)
1. Collagen IV Production at the Follicle Junction
Keratin treatment resulted in increased collagen IV deposition at the follicle junction — the structural region that anchors the follicle within the scalp.
2. Follicle Anchoring
Microscopic imaging demonstrated stronger anchoring of the hair bulb within the follicle structure following keratin exposure.
3. Structural Changes
After 6 days of treatment, researchers observed thickening of the collagen layer surrounding the follicle bulb, indicating structural reinforcement of the follicle attachment point.
Benefits of keraGEN-IV® Demonstrated by This Study
Based directly on the ex-vivo findings, keratin treatment was shown to:
✓ Support increased collagen IV deposition at the hair follicle junction
✓ Support stronger anchoring of the hair bulb within the follicle structure
✓ Support thickening of the collagen layer surrounding the follicle bulb within 6 days
✓ Provide structural reinforcement of follicle attachment points
Why This Study Matters
Although conducted on isolated hair follicles in a laboratory setting, this ex-vivo research provides mechanistic insight into how keratin-derived nutrients may support hair health. The increased collagen IV deposition and stronger follicle anchoring observed help explain the reduction in hair shedding seen in human clinical studies of keraGEN-IV® supplementation.*
Big-Picture Integration with Other Studies
- Study 1: Daily supplementation with 400 mg keraGEN-IV® for 60 days significantly reduced hair shedding by 43.1% and improved skin elasticity (10.1%) and barrier function (12.5% TEWL reduction) compared with placebo in adults with stressed hair.
- Study 2: In cultured human keratinocytes, keraGEN-IV® increased collagen IV production up to 3× and supported 35% faster cell growth under stress conditions, indicating potential support for structural skin proteins.
- Study 3: In an ex-vivo hair follicle model, keratin treatment increased collagen IV deposition and improved structural anchoring of the hair follicle after 6 days, providing mechanistic support for the clinical findings.
Research across human, cellular, and ex-vivo models suggests that keratin-derived amino acids may help support structural proteins involved in hair follicle anchoring and skin integrity. These findings provide a mechanistic explanation for the improvements in hair retention and skin markers observed in clinical research.*
keraGEN-IV® Ingredient Summary & Real-World Relevance
Taken together, the available research suggests that keraGEN-IV® may help support structural proteins involved in maintaining healthy hair follicles, skin architecture, and nail composition. Mechanistic studies indicate that keratin-derived amino acids can stimulate collagen IV production pathways and support cellular resilience, while human clinical research has demonstrated improvements in markers associated with hair retention and skin structure following daily supplementation.
In practical terms, these findings suggest that keraGEN-IV® may help support the structural environment that keeps hair anchored in the scalp and contributes to the appearance of healthy hair, skin, and nails. Consistent intake may help maintain hair follicle integrity, support skin elasticity and barrier function, and provide nutritional support for tissues that rely heavily on structural proteins. When combined with other nutrients that support connective tissue and antioxidant defenses, keraGEN-IV® may serve as part of a comprehensive approach to supporting hair, skin, and nail health from within.*
Ingredient Manufacturer Link: https://ingredients.aidp.com/#keragen-iv
keraGEN-IV® is a clinically studied ingredient used in the following Silver Fern™ Brand product:
*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.