ArticleDermatology and therapy2017
Efficacy and Safety of 5-Fluorouracil 0.5%/Salicylic Acid 10% in the Field-Directed Treatment of Actinic Keratosis: A Phase III, Randomized, Double-Blind, Vehicle-Controlled Trial.
Article in Dermatology and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02289768 (Multicentre, Randomized, Parallel, Double-Blind, Vehicle Controlled Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In The Field-Directed Treatment Of Actinic Keratoses Grade I To II), which is not on this map. Cited by 14 papers, 3 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.
Multicentre, Randomized, Parallel, Double-Blind, Vehicle Controlled Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In The Field-Directed Treatment Of Actinic Keratoses Grade I To II (Field Cancerization)
Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Systematic review of randomized controlled trials of topicals for actinic keratosis field therapy.Archives of dermatological research · 2024Pooled it
- Patient-reported outcomes of topical therapies in actinic keratosis: A systematic review.Dermatologic therapy · 2021Pooled it
- Systematic Literature Review and Network Meta-analysis of the Efficacy and Acceptability of Interventions in Actinic Keratoses.Acta dermato-venereologica · 2021Pooled it
- Chemoprevention in Skin Cancer: What Advice?Cancers · 2026Review
- Real-time LC-OCT monitoring of scalp hypertrophic actinic keratosis clearance following cryotherapy, laser, and 5-fluorouracil therapy.Frontiers in medicine · 2026Article
- The State of the Art in the Treatment of Actinic Keratosis and Field Cancerization: A Narrative Review.Journal of personalized medicine · 2025Review
- Actinic keratosis: comprehensive review of current treatments and emerging therapeutic innovations.Postepy dermatologii i alergologii · 2025Review
- Evaluating the Efficacy and Safety of 4% 5-Fluorouracil Cream in Patients with Actinic Keratosis: An Expert Opinion.Acta dermato-venereologica · 2023Review
- Pharmacological Agents Used in the Prevention and Treatment of Actinic Keratosis: A Review.International journal of molecular sciences · 2023Review
- Comparative Efficacy and Safety of Tirbanibulin for Actinic Keratosis of the Face and Scalp in Europe: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.Journal of clinical medicine · 2022Article
- Use of complete clearance for assessing treatment efficacy for 5-fluorouracil interventions in actinic keratoses: how baseline lesion count can impact this outcome.Journal of market access & health policy · 2020Article
- [Actinic keratoses : Current guideline and practical recommendations].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2020Review
- Prevalence, Discontinuation Rate, and Risk Factors for Severe Local Site Reactions with Topical Field Treatment Options for Actinic Keratosis of the Face and Scalp.Medicina (Kaunas, Lithuania) · 2019Review
- Updates on Psoriasis and Cutaneous Oncology: Proceedings from the 2017 MauiDerm Meeting.The Journal of clinical and aesthetic dermatology · 2017Article
Corrections and comments
- Erratum issued
Authors and funding
8 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDue to the high prevalence of actinic keratosis (AK) and potential for lesions to become cancerous, clinical guidelines recommend that all are treated. The objective of this study was to evaluate the efficacy and safety of 5-fluorouracil (5-FU) 0.5%/salicylic acid 10% as field-directed treatment of AK lesions.
methodsThis multicenter, double-blind, vehicle-controlled study (NCT02289768) randomized adults, with a 25 cm
resultsOf 166 patients randomized, 111 received 5-FU 0.5%/salicylic acid 10% and 55 received vehicle. At 8 weeks after the end of treatment, CCC was significantly higher with 5-FU 0.5%/salicylic acid 10% than with vehicle [49.5% vs. 18.2%, respectively; odds ratio (OR) 3.9 (95% CI) 1.7, 8.7; P = 0.0006]. Significantly more patients achieved PC of lesions with treatment than with vehicle [69.5% vs. 34.6%, respectively; OR 4.9 (95% CI 2.3, 10.5); P < 0.0001]. Treatment-emergent adverse events, predominantly related to application- and administration-site reactions, were more common with 5-FU 0.5%/salicylic acid 10% than with vehicle (99.1% vs. 83.6%).
conclusionsCompared with vehicle, field-directed treatment of AK lesions with 5-FU 0.5%/salicylic acid 10% was effective in terms of CCC. Safety outcomes were consistent with the known and predictable safety profile.
trial registrationNCT02289768.
fundingAlmirall S.A.
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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.