Fabrizio Guarneri
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Previous Organizations / Institutes
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Research Subjects
Fabrizio Guarneri has a total of 269 co-authors. Here are the top co-authors by number of shared publications:
- Luca Stingeni
Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy
13 shared publications Salvatore Benvenga
Endocrinology, Department of Clinical and Experimental Medicine, University of Messina, Via Consolare Valeria 1, 98125 Messina, Italy
13 shared publications- Katharina Hansel
Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy
12 shared publications - Maddalena Napolitano
Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
11 shared publications - Caterina Foti
Section of Dermatology and Venereology, Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe‐J) University of Bari “Aldo Moro” Bari Italy
9 shared publications Claudio Guarneri
Department of Clinical and Experimental Medicine – Dermatology University of Messina Messina Italy
9 shared publications
Latest Publications
- Open Access
- 22 October 2026
- Published by Wiley in Contact Dermatitis
Contact Allergy to Textile Dye Mix in Italy: A SIDAPA Multicentre Observational Study
Background: Disperse dyes, widely used in synthetic textiles, continue to represent a cause of allergic contact dermatitis despite restrictive European regulations. Objectives: To assess prevalence, clinical features, and exposure patterns of Italian patients with positive reactions to the Textile Dye Mix (TDM) 6.6% pet., and to contextualise these findings within European surveillance data and current regulatory frameworks. Patients and Methods: A retrospective multicentre study was performed using the SIDAPA database on patients consecutively patch‐tested with the SIDAPA baseline series from January 2020 to March 2025 in 10 Italian dermatology centres. Demographic, clinical, and occupational data were statistically analysed. Results: A total of 7633 patients were included. Positive reactions to TDM were found in 281 patients (3.68%), mainly females (77.22%). The mean age was 46.43 ± 17.66 years. Clinical relevance was established in 59.79% of reactions, mainly non‐occupational (89.88%). Disperse Orange 3 (tested in 22 TDM positive patients) resulted positive in 14 patients (63.64%). Co‐sensitization with para‐phenylenediamine occurred in 54.8% of TDM‐positive subjects. Conclusions: The observed prevalence (3.68%) exceeds that of previous Italian (1.5%) and European (2%–3%) studies, possibly reflecting imports from non‐EU countries with limited chemical regulation and e‐commerce channels that bypass controls. Improved traceability, updated patch test formulations, and REACH compliance enforcement are essential to mitigate this growing dermatological concern.
- 22 October 2026
- Published by Wiley in Contact Dermatitis
Open AccessContact Allergy to Textile Dye Mix in Italy: A SIDAPA Multicentre Observational Study
Background: Disperse dyes, widely used in synthetic textiles, continue to represent a cause of allergic contact dermatitis despite restrictive European regulations. Objectives: To assess prevalence, clinical features, and exposure patterns of Italian patients with positive reactions to the Textile Dye Mix (TDM) 6.6% pet., and to contextualise these findings within European surveillance data and current regulatory frameworks. Patients and Methods: A retrospective multicentre study was performed using the SIDAPA database on patients consecutively patch‐tested with the SIDAPA baseline series from January 2020 to March 2025 in 10 Italian dermatology centres. Demographic, clinical, and occupational data were statistically analysed. Results: A total of 7633 patients were included. Positive reactions to TDM were found in 281 patients (3.68%), mainly females (77.22%). The mean age was 46.43 ± 17.66 years. Clinical relevance was established in 59.79% of reactions, mainly non‐occupational (89.88%). Disperse Orange 3 (tested in 22 TDM positive patients) resulted positive in 14 patients (63.64%). Co‐sensitization with para‐phenylenediamine occurred in 54.8% of TDM‐positive subjects. Conclusions: The observed prevalence (3.68%) exceeds that of previous Italian (1.5%) and European (2%–3%) studies, possibly reflecting imports from non‐EU countries with limited chemical regulation and e‐commerce channels that bypass controls. Improved traceability, updated patch test formulations, and REACH compliance enforcement are essential to mitigate this growing dermatological concern.
- Open Access
- 15 February 2026
- Published by Wiley in Contact Dermatitis
- Vol. 94 (6) , 662-676
Real‐Life Workup of Chronic Hand Eczema Using a Dedicated Case Report Form: A SIDAPA Multicentre Study
Background: Chronic hand eczema (CHE) is a challenging condition with multifactorial pathomechanisms and a wide clinical polymorphism. It is often resistant to treatments. Objectives: To clinically and etiologically investigate CHE patients using a case report form (CRF) developed for this purpose. Methods: A cross‐sectional study on adult patients affected by CHE was performed from January 2024 to May 2025 in 10 Italian dermatology clinics. Demographic data, clinical features, disease severity and duration, endogenous/environmental risk factors, patch test results, response to past/current treatments, and burden of disease were recorded in the dedicated CRF and analysed. Results: A total of 207 patients were enrolled in the study (mean age 41.1 ± 15.6 years), 142 (68.6%) females. CHE was moderate–severe in 58.9% of cases, refractory to topical potent corticosteroids in 81.4%. The etiological subtypes were irritant contact dermatitis in 52.7%, allergic contact dermatitis in 24.2%, and atopic dermatitis in 16.9%; clinical subtypes were identified in only 29.0% of patients, the most frequent ones being hyperkeratotic eczema (12.1%) and acute recurrent vesicular eczema (9.7%). The CRF proved to be easy to fill in and useful. Conclusions: An accurate clinical workup can lead to CHE clinical and etiological classification in about 80% of patients and may facilitate tailored treatment strategies.
- 15 February 2026
- Published by Wiley in Contact Dermatitis
- Vol. 94 (6) , 662-676
Open AccessReal‐Life Workup of Chronic Hand Eczema Using a Dedicated Case Report Form: A SIDAPA Multicentre Study
Background: Chronic hand eczema (CHE) is a challenging condition with multifactorial pathomechanisms and a wide clinical polymorphism. It is often resistant to treatments. Objectives: To clinically and etiologically investigate CHE patients using a case report form (CRF) developed for this purpose. Methods: A cross‐sectional study on adult patients affected by CHE was performed from January 2024 to May 2025 in 10 Italian dermatology clinics. Demographic data, clinical features, disease severity and duration, endogenous/environmental risk factors, patch test results, response to past/current treatments, and burden of disease were recorded in the dedicated CRF and analysed. Results: A total of 207 patients were enrolled in the study (mean age 41.1 ± 15.6 years), 142 (68.6%) females. CHE was moderate–severe in 58.9% of cases, refractory to topical potent corticosteroids in 81.4%. The etiological subtypes were irritant contact dermatitis in 52.7%, allergic contact dermatitis in 24.2%, and atopic dermatitis in 16.9%; clinical subtypes were identified in only 29.0% of patients, the most frequent ones being hyperkeratotic eczema (12.1%) and acute recurrent vesicular eczema (9.7%). The CRF proved to be easy to fill in and useful. Conclusions: An accurate clinical workup can lead to CHE clinical and etiological classification in about 80% of patients and may facilitate tailored treatment strategies.
- Open Access
- 21 May 2025
- Published by Wiley in Contact Dermatitis
- Vol. 93 (3) , 224-233
The Italian Trend of Contact Allergy to 2‐Hydroxyethyl Methacrylate: Is the Current European Legislation Working?
Background: (Meth)acrylates are well‐known causes of allergic contact dermatitis, and nail products are the major source of exposure, especially in a non‐occupational setting. In 2020, the European legislation restricted 2‐hydroxyethyl methacrylate (2‐HEMA) only in nail cosmetics to professional use.Objective: To investigate the Italian prevalence trend of positive patch test reactions to 2‐HEMA, the best marker for delayed hypersensitivity to (meth)acrylates.Methods: A retrospective descriptive study on consecutive patients patch tested with the Italian baseline series containing 2‐HEMA was performed in 8 Italian Dermatology Clinics. Demographics, patch test results, exposure settings and sources were analysed.Results: Amongst 7133 patch tested patients, 147 (2.1%) resulted positive to 2‐HEMA with an increasing trend from 2019 (1.6%) to 2023 (2.7%). The median age of sensitised female patients with a relevant positive patch test reaction to 2‐HEMA was significantly decreasing over time (p = 0.004). Non‐occupational allergic contact dermatitis was documented in 68.7%; artificial nails were the leading source of exposure in both occupational (75.0%) and non‐occupational (72.2%) settings.Conclusion: The prevalence of contact allergy to 2‐HEMA in Italy shows a progressively increasing trend over time. Currently, the European legislation does not appear to be effective in preventing or reducing this phenomenon.
- 21 May 2025
- Published by Wiley in Contact Dermatitis
- Vol. 93 (3) , 224-233
Open AccessThe Italian Trend of Contact Allergy to 2‐Hydroxyethyl Methacrylate: Is the Current European Legislation Working?
Background: (Meth)acrylates are well‐known causes of allergic contact dermatitis, and nail products are the major source of exposure, especially in a non‐occupational setting. In 2020, the European legislation restricted 2‐hydroxyethyl methacrylate (2‐HEMA) only in nail cosmetics to professional use.Objective: To investigate the Italian prevalence trend of positive patch test reactions to 2‐HEMA, the best marker for delayed hypersensitivity to (meth)acrylates.Methods: A retrospective descriptive study on consecutive patients patch tested with the Italian baseline series containing 2‐HEMA was performed in 8 Italian Dermatology Clinics. Demographics, patch test results, exposure settings and sources were analysed.Results: Amongst 7133 patch tested patients, 147 (2.1%) resulted positive to 2‐HEMA with an increasing trend from 2019 (1.6%) to 2023 (2.7%). The median age of sensitised female patients with a relevant positive patch test reaction to 2‐HEMA was significantly decreasing over time (p = 0.004). Non‐occupational allergic contact dermatitis was documented in 68.7%; artificial nails were the leading source of exposure in both occupational (75.0%) and non‐occupational (72.2%) settings.Conclusion: The prevalence of contact allergy to 2‐HEMA in Italy shows a progressively increasing trend over time. Currently, the European legislation does not appear to be effective in preventing or reducing this phenomenon.
- Open Access
- 25 April 2025
- Published by Wiley in Journal of the European Academy of Dermatology and Venereology
- Vol. 39 (9) , 1588-1599
Consensus on core domains for hand eczema trials: Signs, symptoms, control and quality of life
Background: Hand eczema (HE) is a common and complex skin disease. A uniform set of core outcomes and related measures for use in clinical trials is lacking, making it difficult to compare results across HE studies.Objective: To reach consensus on a set of core domains and subdomains that should be measured in future therapeutic HE trials.Methods: In 2024, we conducted a two‐round online Delphi (eDelphi) survey among international HE experts, including physicians, patients and their relatives, researchers and industry representatives. A domain/subdomain was included in the core set when ≥80% of participants rated is as ‘critically important’; 50% agreement or less resulted in its exclusion. Results from 50% to 80% were deemed controversial and subject for further discussion. During a hybrid consensus meeting, the stakeholders reviewed, completed and, if necessary, revised the preliminary eDelphi consensus.Results: In the first and second round of the eDelphi, 208 and 134 persons, respectively, participated. Forty participants from 18 countries attended the consensus meeting. Consensus was reached to include the core domains ‘signs of HE’ (with five core subdomains), ‘symptoms of HE’ (two subdomains), ‘HE‐related quality of life’ (four subdomains) and ‘HE control over time’ (four subdomains). The subdomains ‘desquamation/scaling’ and ‘emotional impact/mental health’ remained controversial. Consensus was reached that the domains ‘skin barrier function’ and ‘patient‐reported treatment experience’ and 28 subdomains should not be part of the core outcome set.Conclusions: To produce comparable and meaningful results, future trials evaluating the effectiveness of HE treatments should measure signs and symptoms of HE, HE‐related quality of life and HE control over time as core outcome domains. The next step of the HE core outcome set initiative (HECOS) is to identify appropriate measurement instruments.
- 25 April 2025
- Published by Wiley in Journal of the European Academy of Dermatology and Venereology
- Vol. 39 (9) , 1588-1599
Open AccessConsensus on core domains for hand eczema trials: Signs, symptoms, control and quality of life
Background: Hand eczema (HE) is a common and complex skin disease. A uniform set of core outcomes and related measures for use in clinical trials is lacking, making it difficult to compare results across HE studies.Objective: To reach consensus on a set of core domains and subdomains that should be measured in future therapeutic HE trials.Methods: In 2024, we conducted a two‐round online Delphi (eDelphi) survey among international HE experts, including physicians, patients and their relatives, researchers and industry representatives. A domain/subdomain was included in the core set when ≥80% of participants rated is as ‘critically important’; 50% agreement or less resulted in its exclusion. Results from 50% to 80% were deemed controversial and subject for further discussion. During a hybrid consensus meeting, the stakeholders reviewed, completed and, if necessary, revised the preliminary eDelphi consensus.Results: In the first and second round of the eDelphi, 208 and 134 persons, respectively, participated. Forty participants from 18 countries attended the consensus meeting. Consensus was reached to include the core domains ‘signs of HE’ (with five core subdomains), ‘symptoms of HE’ (two subdomains), ‘HE‐related quality of life’ (four subdomains) and ‘HE control over time’ (four subdomains). The subdomains ‘desquamation/scaling’ and ‘emotional impact/mental health’ remained controversial. Consensus was reached that the domains ‘skin barrier function’ and ‘patient‐reported treatment experience’ and 28 subdomains should not be part of the core outcome set.Conclusions: To produce comparable and meaningful results, future trials evaluating the effectiveness of HE treatments should measure signs and symptoms of HE, HE‐related quality of life and HE control over time as core outcome domains. The next step of the HE core outcome set initiative (HECOS) is to identify appropriate measurement instruments.
- Open Access
- 1 February 2025
- Published by Edizioni Minerva Medica in Italian Journal of Dermatology and Venereology
- Vol. 159 (6)
Translation and pre-validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) in Italian
Article: Translation and pre-validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) in Italian - Italian Journal of Dermatology and Venereology 2024 Nov 29 - Minerva Medica - Journals
- 1 February 2025
- Published by Edizioni Minerva Medica in Italian Journal of Dermatology and Venereology
- Vol. 159 (6)
Open AccessTranslation and pre-validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) in Italian
Article: Translation and pre-validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) in Italian - Italian Journal of Dermatology and Venereology 2024 Nov 29 - Minerva Medica - Journals
- 26 August 2024
- Published by Wiley in Contact Dermatitis
- Vol. 92 (1) , 9-20
Hand eczema in Italian patients referred for patch testing: A retrospective SIDAPA study (2016–2023)
Background: Hand eczema (HE) is a common skin disease with a negative impact on patients' quality of life in occupational and non‐occupational settings. Up‐to‐date, data on HE in Italian patients referred for patch testing are lacking. Objectives: To characterise the profile in terms of demographics, aetiology and patch test results of Italian patients affected by HE referred for patch testing. Methods: A retrospective descriptive study on consecutive patients affected by HE who underwent patch testing from 2016 to 2023 in eight dermatology clinics was performed. HE patients were divided into two groups according to the exclusive (HE‐only group) and not‐exclusive (HE+ group) hand involvement, and compared to patients with eczema localised in body areas other than hands (NHE group). Results: One thousand five hundred and ninety‐seven patients were affected by HE (35.3% males; mean age 42.7 years), 60.2% belonging to the HE‐only group and 39.8% to the HE+ group. Occupational dermatitis was diagnosed in 33.2% of HE‐only patients, 25.0% of HE+ patients and 5.2% of NHE patients ( p < 0.001). HE‐only patients presented: Allergic Contact Dermatitis (ACD), Irritant Contact Dermatitis (ICD), atopic HE in 48.1%, 47.5% and 7.1%, respectively; hyperkeratotic palmar, acute recurrent vesicular and nummular clinical subtypes in 52.2%, 43.9% and 11.9%, respectively; relevant positive patch test reactions in 48.1% (nickel sulphate 18.9%, methylchloroisothiazolinone/methylisothiazolinone 10.6%, methylisothiazolinone 8.6%, p ‐phenylenediamine 6.0% and potassium dichromate 4.7%). Conclusions: HE patients, and particularly those with exclusive hand involvement, show a particular profile in terms of demographic and clinical characteristics, etiologies and relevant positive patch test reactions.
- 26 August 2024
- Published by Wiley in Contact Dermatitis
- Vol. 92 (1) , 9-20
Hand eczema in Italian patients referred for patch testing: A retrospective SIDAPA study (2016–2023)
Background: Hand eczema (HE) is a common skin disease with a negative impact on patients' quality of life in occupational and non‐occupational settings. Up‐to‐date, data on HE in Italian patients referred for patch testing are lacking. Objectives: To characterise the profile in terms of demographics, aetiology and patch test results of Italian patients affected by HE referred for patch testing. Methods: A retrospective descriptive study on consecutive patients affected by HE who underwent patch testing from 2016 to 2023 in eight dermatology clinics was performed. HE patients were divided into two groups according to the exclusive (HE‐only group) and not‐exclusive (HE+ group) hand involvement, and compared to patients with eczema localised in body areas other than hands (NHE group). Results: One thousand five hundred and ninety‐seven patients were affected by HE (35.3% males; mean age 42.7 years), 60.2% belonging to the HE‐only group and 39.8% to the HE+ group. Occupational dermatitis was diagnosed in 33.2% of HE‐only patients, 25.0% of HE+ patients and 5.2% of NHE patients ( p < 0.001). HE‐only patients presented: Allergic Contact Dermatitis (ACD), Irritant Contact Dermatitis (ICD), atopic HE in 48.1%, 47.5% and 7.1%, respectively; hyperkeratotic palmar, acute recurrent vesicular and nummular clinical subtypes in 52.2%, 43.9% and 11.9%, respectively; relevant positive patch test reactions in 48.1% (nickel sulphate 18.9%, methylchloroisothiazolinone/methylisothiazolinone 10.6%, methylisothiazolinone 8.6%, p ‐phenylenediamine 6.0% and potassium dichromate 4.7%). Conclusions: HE patients, and particularly those with exclusive hand involvement, show a particular profile in terms of demographic and clinical characteristics, etiologies and relevant positive patch test reactions.
- 24 January 2024
- Published by Wiley in Contact Dermatitis
- Vol. 90 (5) , 479-485
Contact allergy to SIDAPA baseline series allergens in patients with eyelid dermatitis: An Italian multicentre study
Background: Eyelid dermatitis is a frequent reason of dermatological consultation. Its aetiology is not univocal, being contact dermatitis, both allergic and irritant, the most frequent. The primary sources of allergen exposure include cosmetics, metals, and topical medications, from direct, indirect, or airborne contact.Objectives: To define the frequency of positive patch test reactions to SIDAPA baseline series allergens, to document positive allergens, and to precise the final diagnosis in patients with eyelid involvement.Methods: A total of 8557 consecutive patients from 12 Italian Dermatology Clinics underwent patch testing with SIDAPA baseline series in 2018 and 2019. Patients were divided into two groups: (i) with eyelid involvement with or without other involved sites (E‐Group) and (ii) without eyelid involvement (NE‐Group). The final diagnosis and the frequency of positive relevant patch test reactions were evaluated.Results: E‐Group consisted of 688 patients (females 78.6%, mean age 45.3 years), 8.0% of 8557 consecutively patch‐tested patients. The final diagnosis in E‐Group was ADC in 42.4%, ICD in 34.2%, and AD in 30.5%. The highest reaction rates were elicited by nickel sulphate and methylchloroisothiazolinone/methylisothiazolinone in both E‐Group and NE‐Group, even if these allergens were significantly more frequently positive in NE‐Group patients than in E‐Group ones. Positive patch test reactions to fragrance Mix II, dimethylaminopropylamine, and sorbitan sesquiolate were significantly more frequent in E‐Group patients than in NE‐Group ones.Conclusions: Eyelid dermatitis is a frequent dermatological complaint. Allergic contact dermatitis is the most frequent diagnosis commonly caused by nickel sulphate, isothiazolinones, and fragrances. The surfactants dimethylaminopropylamine and sorbitan sesquioleate are emerging causes of eyelid allergic contact dermatitis.
- 24 January 2024
- Published by Wiley in Contact Dermatitis
- Vol. 90 (5) , 479-485
Contact allergy to SIDAPA baseline series allergens in patients with eyelid dermatitis: An Italian multicentre study
Background: Eyelid dermatitis is a frequent reason of dermatological consultation. Its aetiology is not univocal, being contact dermatitis, both allergic and irritant, the most frequent. The primary sources of allergen exposure include cosmetics, metals, and topical medications, from direct, indirect, or airborne contact.Objectives: To define the frequency of positive patch test reactions to SIDAPA baseline series allergens, to document positive allergens, and to precise the final diagnosis in patients with eyelid involvement.Methods: A total of 8557 consecutive patients from 12 Italian Dermatology Clinics underwent patch testing with SIDAPA baseline series in 2018 and 2019. Patients were divided into two groups: (i) with eyelid involvement with or without other involved sites (E‐Group) and (ii) without eyelid involvement (NE‐Group). The final diagnosis and the frequency of positive relevant patch test reactions were evaluated.Results: E‐Group consisted of 688 patients (females 78.6%, mean age 45.3 years), 8.0% of 8557 consecutively patch‐tested patients. The final diagnosis in E‐Group was ADC in 42.4%, ICD in 34.2%, and AD in 30.5%. The highest reaction rates were elicited by nickel sulphate and methylchloroisothiazolinone/methylisothiazolinone in both E‐Group and NE‐Group, even if these allergens were significantly more frequently positive in NE‐Group patients than in E‐Group ones. Positive patch test reactions to fragrance Mix II, dimethylaminopropylamine, and sorbitan sesquiolate were significantly more frequent in E‐Group patients than in NE‐Group ones.Conclusions: Eyelid dermatitis is a frequent dermatological complaint. Allergic contact dermatitis is the most frequent diagnosis commonly caused by nickel sulphate, isothiazolinones, and fragrances. The surfactants dimethylaminopropylamine and sorbitan sesquioleate are emerging causes of eyelid allergic contact dermatitis.
- Open Access
- 3 December 2023
- Published by Wiley in Contact Dermatitis
- Vol. 90 (3) , 314-317
Frequency of contact allergy to pentylene glycol. Retrospective cross‐sectional study with data from the Società Italiana di Dermatologia Allergologica Professionale e Ambientale (SIDAPA)
- 3 December 2023
- Published by Wiley in Contact Dermatitis
- Vol. 90 (3) , 314-317
Open AccessFrequency of contact allergy to pentylene glycol. Retrospective cross‐sectional study with data from the Società Italiana di Dermatologia Allergologica Professionale e Ambientale (SIDAPA)
- 6 July 2023
- Published by Oxford University Press (OUP) in British Journal of Dermatology
- Vol. 189 (5) , 626-628
Facial naevus count in the identification of patients at higher risk of melanoma
A high total body naevus count (TBNC) is a major risk factor for melanoma. The aim of our study was to investigate the correlation between the number of facial naevi and TBNC, and how the patient variables could influence this association. Our findings suggest that facial naevus count is a fast, easy and economical tool to identify individuals with a high TBNC and may be useful as screening method for physicians in all medical fields.
- 6 July 2023
- Published by Oxford University Press (OUP) in British Journal of Dermatology
- Vol. 189 (5) , 626-628
Facial naevus count in the identification of patients at higher risk of melanoma
A high total body naevus count (TBNC) is a major risk factor for melanoma. The aim of our study was to investigate the correlation between the number of facial naevi and TBNC, and how the patient variables could influence this association. Our findings suggest that facial naevus count is a fast, easy and economical tool to identify individuals with a high TBNC and may be useful as screening method for physicians in all medical fields.
- Open Access
Actinic Keratoses: A Prospective Pilot Study on a Novel Formulation of 4% 5-Fluorouracil Cream and a Review of Other Current Topical Treatment Options
Background: Actinic keratosis (AK) is one of the most common skin diseases, with a low risk of progression into invasive squamous cell carcinoma. We aim to assess efficacy and safety of a novel formulation of 5-Fluorouracil (5-FU) 4% with once daily application for the treatment of multiple AKs. Methods: A pilot study was performed on 30 patients with a clinical and dermoscopic diagnosis of multiple AKs, enrolled between September 2021 and May 2022 at the Dermatology Departments of two Italian hospitals. Patients were treated with 5-FU 4% cream once daily for 30 consecutive days. The Actinic Keratosis Area and Severity Index (AKASI) was calculated before starting therapy, and at each follow-up, to assess objective clinical response. Results: The cohort analyzed included 14 (47%) males and 16 (53%) females (mean age: 71 ± 12 years). A significant decrease in AKASI score at both 6 and 12 weeks (p < 0.0001) was observed. Only three patients (10%) discontinued therapy, and 13 patients (43%) did not report any adverse reactions; no unexpected adverse events were observed. Conclusions: In the setting of topical chemotherapy and immunotherapy, the new formulation of 5-FU 4% proved to be a highly effective treatment for AKs and field cancerization.
Open AccessActinic Keratoses: A Prospective Pilot Study on a Novel Formulation of 4% 5-Fluorouracil Cream and a Review of Other Current Topical Treatment Options
Background: Actinic keratosis (AK) is one of the most common skin diseases, with a low risk of progression into invasive squamous cell carcinoma. We aim to assess efficacy and safety of a novel formulation of 5-Fluorouracil (5-FU) 4% with once daily application for the treatment of multiple AKs. Methods: A pilot study was performed on 30 patients with a clinical and dermoscopic diagnosis of multiple AKs, enrolled between September 2021 and May 2022 at the Dermatology Departments of two Italian hospitals. Patients were treated with 5-FU 4% cream once daily for 30 consecutive days. The Actinic Keratosis Area and Severity Index (AKASI) was calculated before starting therapy, and at each follow-up, to assess objective clinical response. Results: The cohort analyzed included 14 (47%) males and 16 (53%) females (mean age: 71 ± 12 years). A significant decrease in AKASI score at both 6 and 12 weeks (p < 0.0001) was observed. Only three patients (10%) discontinued therapy, and 13 patients (43%) did not report any adverse reactions; no unexpected adverse events were observed. Conclusions: In the setting of topical chemotherapy and immunotherapy, the new formulation of 5-FU 4% proved to be a highly effective treatment for AKs and field cancerization.