Trial reportThe Journal of clinical investigation2017
Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy.
Trial report in The Journal of clinical investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 72 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions
Phase I, Dual Arm, Open-Label, Trial of Intralesional 5-Fluorouracil (5FU) and Intralesional 5FU Combined With Topical Calcipotriene in Patients With Squamous Cell Carcinoma (SCC) of the Lower Extremities
Combination Calcipotriene 0.005% Foam and Fluorouracil 5% Cream for the Treatment of Actinic Keratoses on the Scalp
Calcipotriol Plus 5-Flourouracil Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients
Calcipotriol Plus 5-Fluorouracil Immunotherapy for Skin Cancer Prevention in Organ Transplant Recipients
Combination Topical 5-fluorouracil 5% / Calcipotriene 0.005% Cream for Treatment of in Situ and Superficially Invasive Squamous Cell Carcinoma of the Skin
Who cites it
72 citing papers in PubMed, 5 syntheses or guidelines pooled it, 174 citations in OpenAlex.
- Systematic review of randomized controlled trials of topicals for actinic keratosis field therapy.Archives of dermatological research · 2024Pooled it
- Treatment of actinic keratosis: a systematic review.Archives of dermatological research · 2023Pooled it
- Genome-wide association study of actinic keratosis identifies new susceptibility loci implicated in pigmentation and immune regulation pathways.Communications biology · 2022Pooled it
- Guidelines of care for the management of actinic keratosis.Journal of the American Academy of Dermatology · 2021Pooled it
- Guidelines of care for the management of actinic keratosis: Executive summary.Journal of the American Academy of Dermatology · 2021Pooled it
- Topical treatment of actinic keratoses in organ transplant recipients: a feasibility study for SPOT (Squamous cell carcinoma Prevention in Organ transplant recipients using Topical treatments).The British journal of dermatology · 2022Trial
- Trial
- Localized nasal porokeratosis successfully treated with 5-fluorouracil and calcipotriene.JAAD case reports · 2026Article
- Skin-penetrating peptides derived from computational simulation improve transdermal absorption and facilitate topical treatment of melanoma.Acta pharmaceutica Sinica. B · 2026Article
- Chemoprevention in Skin Cancer: What Advice?Cancers · 2026Review
- Efficacy of 4% 5-Fluorouracil Cream in the Treatment of Actinic Keratoses: A Single-Center Experience.Journal of clinical medicine · 2026Article
- The State of the Art in the Treatment of Actinic Keratosis and Field Cancerization: A Narrative Review.Journal of personalized medicine · 2025Review
- Local Chemotherapy of Skin Pre-Neoplastic Lesions and Malignancies from the Perspective of Current Pharmaceutics.Pharmaceutics · 2025Review
- Actinic keratosis: comprehensive review of current treatments and emerging therapeutic innovations.Postepy dermatologii i alergologii · 2025Review
- Calcipotriol as a daylight photodynamic therapy enhancer: a case-control study.Dermatology reports · 2025Article
- Targeting regulated cell death: Apoptosis, necroptosis, pyroptosis, ferroptosis, and cuproptosis in anticancer immunity.Journal of translational internal medicine · 2025Article
- CD4+ T helper 2 cell-macrophage crosstalk induces IL-24-mediated breast cancer suppression.JCI insight · 2025Article
- Type 2 immunity to the rescue: enhancing antitumor immunity for skin cancer prevention.The Journal of clinical investigation · 2025Article
- T helper 2 cell-directed immunotherapy eliminates precancerous skin lesions.The Journal of clinical investigation · 2025Article
- Combating Methotrexate Resistance in Cancer Treatment: A Review on Navigating Pathways and Enhancing Its Efficacy With Fat-Soluble Vitamins.Scientifica · 2025Review
12 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundActinic keratosis is a precursor to cutaneous squamous cell carcinoma. Long treatment durations and severe side effects have limited the efficacy of current actinic keratosis treatments. Thymic stromal lymphopoietin (TSLP) is an epithelium-derived cytokine that induces a robust antitumor immunity in barrier-defective skin. Here, we investigated the efficacy of calcipotriol, a topical TSLP inducer, in combination with 5-fluorouracil (5-FU) as an immunotherapy for actinic keratosis.
methodsThe mechanism of calcipotriol action against skin carcinogenesis was examined in genetically engineered mouse models. The efficacy and safety of 0.005% calcipotriol ointment combined with 5% 5-FU cream were compared with Vaseline plus 5-FU for the field treatment of actinic keratosis in a randomized, double-blind clinical trial involving 131 participants. The assigned treatment was self-applied to the entirety of the qualified anatomical sites (face, scalp, and upper extremities) twice daily for 4 consecutive days. The percentage of reduction in the number of actinic keratoses (primary outcome), local skin reactions, and immune activation parameters were assessed.
resultsCalcipotriol suppressed skin cancer development in mice in a TSLP-dependent manner. Four-day application of calcipotriol plus 5-FU versus Vaseline plus 5-FU led to an 87.8% versus 26.3% mean reduction in the number of actinic keratoses in participants (P < 0.0001). Importantly, calcipotriol plus 5-FU treatment induced TSLP, HLA class II, and natural killer cell group 2D (NKG2D) ligand expression in the lesional keratinocytes associated with a marked CD4+ T cell infiltration, which peaked on days 10-11 after treatment, without pain, crusting, or ulceration.
conclusionOur findings demonstrate the synergistic effects of calcipotriol and 5-FU treatment in optimally activating a CD4+ T cell-mediated immunity against actinic keratoses and, potentially, cancers of the skin and other organs.
trial registrationClinicalTrials.gov NCT02019355.
fundingNot applicable (investigator-initiated clinical trial).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.