A New Immune-Directed
Approach to
Actinic Keratosis
Emerging clinical evidence suggests that combining topical 5-FU with calcipotriene may activate the immune system to enhance the clearance of actinic keratoses while establishing long-term immune memory.
Supported by published clinical research and an exclusive commercial partnership with Washington University in St. Louis, SKNV is advancing the science behind this differentiated therapeutic approach.
Clinical Evidence at a Glance
Published research demonstrates significant efficacy and long-term benefits
Mean AK reduction on the face
vs. 26.3% with 5-FU alone
Treatment duration
Twice-daily application
SCC incidence (treated)
vs. 28% in control group at 3 years
Statistical significance
Primary efficacy endpoint
Why This Matters
Actinic keratosis affects millions of Americans each year and remains one of the most common reasons patients visit a dermatologist. Although several field-directed therapies are available, treatment duration, tolerability, and adherence continue to present challenges.
Emerging research into immune-directed approaches has created new opportunities to improve field treatment while potentially influencing long-term disease biology.
The Foundation of Innovation
Four pillars supporting the advancement of immune-directed therapy
Scientific Discovery
Calcipotriene induces TSLP (thymic stromal lymphopoietin), activating the immune system to recognize and destroy pre-cancerous keratinocytes. Combined with 5-FU, this creates synergistic immune-directed clearance.
Clinical Validation
A randomized, double-blind trial of 131 participants showed 87.8% mean AK reduction on the face versus 26.3% with 5-FU alone — in just 4 days of twice-daily application. P < 0.0001
Long-Term Immune Response
A 3-year follow-up cohort study (Rosenberg et al., JCI Insight 2019) found 7% vs. 28% SCC incidence on treated face/scalp, suggesting durable immune memory establishment. P = 0.032
Intellectual Property
Three active U.S. patents (issued 2021, 2022, 2025) covering methods of treatment for AK and SCC/SCCIS, and composition claims with specific concentration ranges. All expire 2035–2036.
How the Combination Works
A timeline of immune activation and therapeutic response
Treatment Application
Topical 5-FU + calcipotriene applied twice daily to affected areas
Four-day treatment regimen begins
TSLP Induction
Calcipotriene triggers thymic stromal lymphopoietin production
Immune cascade activation starts
Peak Immune Response
CD4+ T cells activated, inflammatory response visible
Redness and inflammation peak around day 10-11
Lesion Clearance
Actinic keratoses begin to resolve as immune system targets damaged cells
Visible improvement in treated areas
Continued Improvement
Progressive clearance of both visible and subclinical lesions
Skin continues to heal and regenerate
Immune Memory Establishment
Tissue-resident memory T cells maintain long-term surveillance
Reduced SCC incidence observed in follow-up studies