Assessment of sinecatechins 10% ointment used as proactive sequential therapy in recurrence rate of genital warts lesions after cryotherapy. The PACT-II Trial (postablation immunomodulator treatment of condylomata with sinecatechins): a prospective assessor-blinded, multicenter, pilot trial.

BACKGROUND: Cryotherapy is commonly used as ablative treatment of external genital warts (EGW). However, after cryotherapy recurrence of lesions affects on average 45% (42-70%) of subjects in the 6 months after the treatment. Sinecatechins 10% are an effective topical treatment of EGW. A low recurrence rate (<6%) was observed in pivotal phase 3 trials conducted with this product. Topical sinecatechins have demonstrated to significantly reduce the recurrence rate of EGW in subjects treated with laser therapy (The PACT-I trial). So far, no prospective data are available regarding the efficacy of sinecathechins as immunomodulator sequential therapy after cryotherapy in EGW subjects. The purpose of this study was to assess the rate of recurrence lesions after the use of topical sinecatechins 10%, as sequential proactive immunomodulation treatment after cryotherapy in subjects with EGW (The PACT-II Trial: the postablation immunomodulator treatment of condylomata with sinecatechins trial) (Trial Registration number: ISRCTN44037479). METHODS: In a prospective, assessor-blinded, multicenter trial a total of 55 subjects with a diagnosis of multiple EGW (36 men and 19 women, mean age 47±10 years) and a mean lesion number of 9±7, after their informed consent, were enrolled in the study. All subjects were treated with cryotherapy (an average of 2 sessions). After the ablative treatment, all subjects were instructed to apply sinecatechin 10% ointment 3 times daily for 4 consecutive months. The primary study endpoint was the evaluation (assessor-blinded) of recurrent lesions after 6 months (2 month of follow-up after the conclusion of topical treatment). The secondary study endpoints were the appearance of new EGW lesions (lesions affecting area not treated by cryotherapy) and the local tolerability. RESULTS: At baseline, the mean number of EGW lesions were 9±7. After cryotherapy, the mean lesions number were reduced to 1.6±1.8. At month 4, EGW mean lesion number were 0.2±0.4 (P=0.0001 vs. after cryotherapy). At month 6, recurrence of lesions was detected in 10 subjects (18%; 95% CI: 9-30%) with an average of 1.4 lesions. Of these recurrent lesions, 6 occurred in completely healed lesions site after cryotherapy and 8 in partially healed ones. New lesions (outside the cryotherapy treated area) were observed in 10 subjects. The product was very well tolerated. No serious side effects were reported. Three subjects reported moderate skin irritation on the application site. CONCLUSIONS: The PACT-II Trial has shown that the recurrence rate of EGW lesions after successful cryotherapy using sinecatechins as immunomodulator sequential therapy is lower in comparison with the percentage documented in the literature without sequential therapy (20 vs. 45%). These results are in line with already published data evaluating the role of sinecatechins after laser therapy (PACT-I trial). Future comparative, double-blind controlled trials assessing the efficacy of different proactive strategies are warranted.

In Vivo Melanoma Cell Morphology Reflects Molecular Signature and Tumor Aggressiveness.

Melanoma is the deadliest type of skin cancer characterized by high cellular heterogeneity, which contributes to therapy resistance and unpredictable disease outcome. Recently, by correlating reflectance confocal microscopy morphology with histopathological type, we identified four distinct melanoma subtypes: dendritic cell, round cell, dermal nest, and combined-type melanomas. In this study, each reflectance confocal microscopy melanoma subtype expressed a specific biomolecular profile and biological behavior in vitro. Markers of tumor aggressiveness, including Ki-67, MERTK, nestin, and stemness markers were highest in the most invasive combined-type and dermal nest melanomas than in dendritic cell and round cell melanomas. This was also confirmed in multicellular tumor spheroids. Transcriptomic analysis showed modulation of cancer progression-associated genes from dendritic cell to combined-type melanomas. The switch from E- to N-cadherin expression proved the epithelial-to-mesenchymal transition from dendritic cell to combined-type subtypes. The dermal nest melanoma was predominantly located in the dermis, as also shown in skin reconstructs. It displayed a unique behavior and a molecular profile associated with a high degree of aggressiveness. Altogether, our results show that each reflectance confocal microscopy melanoma subtype has a distinct biological and gene expression profile related to tumor aggressiveness, confirming that reflectance confocal microscopy can be a dependable tool for in vivo detection of different types of melanoma and for early diagnostic screening.

The Effect of the COVID-19 Lockdown on Melanoma Diagnosis in Italy.

The coronavirus disease 2019 (COVID-19) pandemic has led to lockdowns for much of the world. In Italy, all health procedures not directly related to COVID-19 were reduced or suspended, thus limiting patient access to hospitals. Any delay in cancer treatment presents the additional risk of tumors progressing from being curable to incurable. Specifically, melanoma survival rate strictly depends on tumor thickness, which, in turn, is a function of time. To estimate the impact on melanoma progression caused by the reduction in dermatologic services during the COVID-19 lockdown, a retrospective observational cohort study was conducted. This study was designed to compare the clinical and histologic characteristics of the primary melanomas removed in the first 2 months after the end of the lockdown (May-July 2020) in 12 Italian centers characterized by different COVID-19 case frequencies. The control group was represented by the melanomas removed during the same period in the previous 3 years. Overall, 1,124 melanomas were considered: 237 as part of the study group and 887 from the control group (average, 295), with a 20% reduction. Breslow thickness, as well as high-risk histotypes and melanomas with vertical growth, increased for all melanomas. Ulcerated and high mitotic index melanomas increased, particularly in northern Italy. In Italy, the lockdown led to a significant worsening of melanoma severity, causing a staging jump, with a consequent worsening of outcomes.

Efficacy and tolerability of a cream containing modified glutathione (GSH-C4), beta-Glycyrrhetic, and azelaic acids in mild-to-moderate rosacea: A pilot, assessor-blinded, VISIA and ANTERA 3-D analysis, two-center study (The "Rosazel" Trial).

BACKGROUND: Rosacea is a very common, chronic inflammatory disease characterized by flushing, erythema and inflammatory lesions. Increased oxidative stress plays a relevant pathogenetic role in Rosacea. Intracellular Glutathione (GSH) is the main scavenger protective mechanism against increased oxidative stress. An altered GSH metabolism in Rosacea has been described. GSH-C4 is a modified GSH molecule characterized by a better intracellular bioavailability and longer half-life. A daily cream (E-AR) containing GSH-C4 (0.1%) with beta-Glycyrrhetic (0.5%) and azelaic acids (10%), with an SPF of 30, is available. AIM: In a pilot, prospective, two-center, assessor-blinded study we evaluate the efficacy and the tolerability of E-AR cream in subjects with mild to moderate Rosacea treated for 8 weeks. PATIENTS AND METHODS: The main outcomes were the Investigator Global Assessment (IGA) 7-point score (from 0, completely clear; to 6, severe) and the clinical and instrumental erythema severity score (ESS) (from 0 to 4) evaluated in a blinded fashion (randomly coded photographs) at baseline, after 4 (only clinical) and 8 weeks (clinical and instrumental). VISIA evaluation for erythema and lesion counts and ANTERA 3D analysis for skin haemoglobin concentration (a parameter associated with inflammation) were also performed at the same time points. Analysis of primary outcomes was performed on an intention-to-treat basis. Tolerability was evaluated at week 4 and 8 recording spontaneously reported side effects. RESULTS: Thirty subjects (22 women and 8 men; mean age 38 years) were enrolled after their written informed consent. Twenty-six (87%) subjects completed the study phases. Four subjects stopped prematurely the trial due to low skin tolerability (n=3) or lost to follow-up (n=1). At baseline, mean (SD) IGA score was 2.6 (0.9). At week 4, IGA score decreased (NS) to 2.3 (1.2). IGA score decreased significantly (p=0.0001) at week 8 to 1.2 (1) (mean difference 1.3; 95% CI of the difference from 0.9 to 1.7) in comparison with the baseline. The inflammatory mean (SD) lesion count, evaluated clinically, were 5.1(2.5) at baseline, 2.8 (1.9) at week 4, and 1.9 (1.7) at week 8 (P=0.0001; ANOVA Test), representing a 63% reduction. This reduction was confirmed by inflammatory lesions count performed on VISIA pictures (from 4.5 at baseline to 1.7 lesions at week 8). Similar evolution was observed for the clinical and instrumental ESS with a reduction of 56% (clinical) and 48% (VISIA), respectively, at week 8 in comparison with the baseline. ANTERA 3D photographs confirmed the positive evolution observed clinically with a significant reduction (-24%) in hemoglobin content: from 1.88 at baseline to 1.44 at week 8. CONCLUSION: This new GSH-C4, beta-glycyrrethic and azelaic acids cream has shown to be efficacious in mild to moderate rosacea subjects. Local tolerability is in line with other anti-rosacea treatments.

Efficacy of lidocaine 7 %, tetracaine 7 % self-occlusive cream in reducing MAL-cPDT-associated pain in subjects with actinic keratosis: A randomized, single-blind, vehicle-controlled trial (The "3P-Trial").

INTRODUCTION: Conventional photodynamic therapy (cPDT) is considered a very effective treatment of actinic keratosis (AK) lesions. However, its use is limited by the fact that this procedure could be very painful. The use of topical anesthetics such as tetracaine or lignocaine/prilocaine has shown disappointing results in term of pain reduction. A self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream (LT-C) approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures is available. There are no data regarding its pain reducing effect during cPDT. We perform a prospective, randomized, single-blind, two-center trial (The 3P-Trial) to assess the pain reduction effect of LT-C versus vehicle in subjects with AK undergoing cPDT. MATERIAL AND METHODS: Fifty AK subjects (74 ± 10 years, 32 men, 18 women) with on average 17 lesions were enrolled after their written informed consent. Eight subjects presented also a total of 16 basal cell carcinoma lesions. Twenty-five were randomized to LT-cream, applied 1 h before the Methyl amino levulinate (MAL)-cPDT session and 25 to cream vehicle. The main outcome was the patient-assessed evaluation of pain score during and just after the conclusion of cPDT session (mean of the two values) using a 10-point visual analog scale (VAS). The cPDT session (LED Red light 630 nm) was performed with a duration of 6 ± 2 min with a standard fluence of 37 J/cm2. All treated lesions were prepared by gentle superficial curettage. RESULTS: All the randomized subjects concluded the trial. The mean ± SD of VAS score in vehicle group was 6.2 ± 2.7 (95 % CI of the mean: 5.0-7.5). In the group treated with LT-cream the VAS score was 3.3 ± 1.9 (95 % CI of the mean: 2.5-4.1). The active cream reduced the VAS score by 47 %. Median values of pain VAS score in the active group was reduced by 60 % in comparison with vehicle group (3.0 vs 7.5). The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test). DISCUSSION: The 3P-trial has demonstrated that the preventive application of the self-occlusive lidocaine 7%-tetracaine 7% cream is very effective in reducing the procedure-associated pain during MAL-cPDT for the treatment of AK lesions.

When basal cell carcinomas became giant: an Italian multicenter study.

BACKGROUND: Giant basal cell carcinoma (GBCC) is a basal cell carcinoma (BCC) enlarged in a diameter more than 5 cm. Since GBCCs are a highly infrequent entity and the occurrence rate is approximately 0.5-1% out of all BCC types, only anecdotal cases are reported, and causes and characteristics inducing development of this tumor are not defined. OBJECTIVES: Evaluate causative factors and clinico-histological characteristics of GBCCs. METHODS: The study is a 6-month, hospital-based case series study performed in 12 Italian dermatologic centers. RESULTS: A total of 59 cases and 458 control BCCs were collected. No significant differences existed between the two groups if we take into account social or cultural factors. The average duration of GBCCs is considerably longer than controls. GBCCs are located on unexposed areas while BCCs are on areas not usually covered by clothes. Superficial histological subtype was more frequent in the BCCs group, while infiltrative in GBCCs. GBCCs showed significantly higher local invasiveness, and greater metastatic capacity. More than half of GBCCs had been previously treated with one or more treatments. CONCLUSIONS: Patients with GBCCs appear to belong to two categories: (i) those who present with GBCC due to delay in accessing medical attention, and (ii) those who have BCCs previously treated with inappropriate strategies. Only very few cases can be carried out with intrinsic biological features of tumor aggressiveness. Social and cultural conditions do not appear to be involved in the development of GBCCS. These observations may help clinicians in selecting correct therapeutic strategies in the treatment of BCCs, which give rise to GBCC.

The SILVER study. Efficacy of topical nitric-zinc complex solution in the treatment of resistant warts: A postmarketing evaluation.

The treatment of cutaneous viral warts caused by human papillomavirus (HPV) infection is often subject to local recurrence and a long clinical and treatment course. Our aim was to analyze real-life data on the treatment of difficult-to-treat warts from a multicenter postmarketing surveillance assessment on the efficacy, tolerability, and safety of a commercially available nitric-zinc complex solution (NZCS). Dermatologists from 14 Italian centers completed a questionnaire about their clinical experience on treatment of "difficult-to-treat" warts, which included warts in the plantar, periungual, anogenital and aesthetically sensitive areas. The questionnaire was designed to obtain detailed information on wart treatment and compare NZCS efficacy with previous treatments. Of 106 questionnaires returned, 83 reported NZCS use; 67 had previous treatments (23 cryotherapy, 2 electrocoagulation, 12 other topical application, and 30 combined treatment, such as laser, cryotherapy, and/or electrocoagulation). NZCS had superior efficacy to that of previous treatments (p < .0001), resulting in 84.1% with a full or partial clearance (vs. 44.8% for previous treatments), and had better local tolerability (p < .0001). NZCS showed better efficacy and tolerability than other previous wart treatments.

Efficacy of sinecatechins 10% as proactive sequential therapy of external genital warts after laser CO2 ablative therapy: The PACT study (post-ablation immunomodulator treatment of condylomata with sinecatechins): a randomized, masked outcome assessment, multicenter trial.

External genital warts (EGW) are the most common viral sexually transmitted infection. Ablative treatments like cryotherapy, curettage, and CO2 laser therapies offer rapid onset of effect, fast clearance, and reduction of virus load. However, these procedures are associated with high recurrence rates (RRs) ranging from 20% to 77% in the short and medium terms and do not provide sustained clearance. After laser therapy removal of EGW, an RR up to 77% has been reported. Topical sinecatechins (TS) 10% is a patient-applied regimen for the treatment of EGW with a low RR (<6.5%) at three months after completion of the therapy in the pivotal trials conducted so far. Sinecatechins can be considered a suitable proactive sequential therapy (PST) after ablative strategies to obtain a low RR. So far, no prospective data are available regarding the efficacy of sinecatechins 10% as PST. We evaluated the efficacy and tolerability of TS 10% ointment applied twice daily in subjects with "difficult to treat" EGW after CO2 laser ablative treatment in a prospective controlled trial. A total of 87 subjects (76 men and 11 women; mean age 42 years) were enrolled in this three-month masked outcome assessment parallel group trial with imbalanced randomization allocation (2:1). One week after a successful CO2 laser treatment, 60 subjects were randomized to TS 10% treatment and 27 subjects to no treatment (control group: ConTRol (CTR); no sequential therapy). All patients had a history of an average of 4.5 previous ablative treatments in the last 12 months due to recurrent EGW. Mean (standard deviation) baseline number of treated lesions was 6.5 (2.7). One subject in the TS arm dropped out due to burning sensation after the application of the product. Therefore, 86 subjects completed the study. After three months, in the TS group, three subjects presented new EGW lesions (RR: 5%) on treated sites. In the CTR group, eight subjects presented new EGW lesions (RR: 29%) on treated sites (p = 0.0024; odds ratio: 0.16; 95% confidence interval: 0.04-0.68). In the TS group, 34 subjects (56%) reported mild to moderate erythema or burning sensation at the application site. In this prospective multicenter trial, the use of TS 10% as PST after ablative treatment with CO2 laser was associated with a lower recurrence rate of new EGW lesions in the short term in comparison with the control group. Comparative larger trials are warranted to evaluate the role of this approach as PST (Trial Registration Number: ISRCTN44037479).

Treatment of Grade II and III Actinic Keratosis Lesions with a Film-Forming Medical Device Containing Sunscreen/Piroxicam 0.8% and a Retinoic Acid/Glycolic Gel: A Pilot Trial.

INTRODUCTION: Lesion and field-targeted treatments of actinic keratosis (AK) are commonly indicated for grade I and II type lesions. Grade III lesions are in general more difficult to treat. A film-forming medical device containing piroxicam 0.8% and sunscreen (SPF 50+) (PS) has been shown to be effective in the treatment of grade I and II AK lesions. Topical and oral retinoids have been utilized in AK and non-melanoma skin cancers. Topical glycolic acid promotes keratolysis and stimulates collagen synthesis for repair and skin rejuvenation and could be useful in AK treatment strategies. A gel containing retinoid acid (0.02%) and glycolic acid (4%) (RC) is commercially available. The objective of the study was to evaluate the efficacy and local tolerability of a combined treatment approach with PS and RC in subjects with multiple grade II and III AK lesions. METHODS: Twenty-two subjects (16 males and 6 females; mean age 68 years) with more than five AK lesions were enrolled after obtaining their informed consent in a 3-month trial. PS cream was applied twice daily every day and RC gel was applied twice daily for 2 consecutive days every week. The primary endpoint was the evolution of the AK mean number from baseline to the end of the trial. Secondary endpoints were the thickness of the target lesion (expressed in mm3) and the erythema score (hemoglobin content), evaluated using a standardized computer-based image acquisition analysis system (Anthera 3D). RESULTS: At baseline, the mean (SD) lesion number was 7.7 (3) for grade II and 1.4 (1) for grade III AK. At the end of the study, a significant (P = 0.001) reduction was observed for both grade II (- 81%; from 7.7 to 1.5) and grade III (- 22%) lesions. Six grade III lesions out of 31 (20%), presented at baseline, completely disappeared at month 3. For grade III lesions, a significant mean thickness reduction of 51% was observed at month 3. The erythema score (all lesions) was reduced by 70%. Four patients out of 22 (18%) were completely free of AK lesions at month 3. No severe side effects were reported. CONCLUSION: In this exploratory trial, a combined treatment with a cream containing piroxicam and sunscreen and a retinoic/glycolic gel was associated with a substantial reduction of both grade II and III AK lesions with good local tolerability. FUNDING: Cantabria Labs Difa Cooper.

Spalthauttransplantation zur Defektdeckung am Ohr: eine statistische Analyse.

HINTERGRUND UND ZIELE: Die Rekonstruktion nach Entfernung ausgedehnter maligner Hauttumoren am Ohr ist eine Herausforderung. Verschiedene Methoden der Defektdeckung wurden beschrieben. Lappenplastiken, längere Anästhesiezeiten, geringe Compliance und Antikoagulation stellen bei den oft älteren Patienten zusätzliche Risiken dar. Eine rasch, effizient und unkompliziert durchführbare Methode der Defektdeckung ist daher wünschenswert. Ziel der Studie war die Beurteilung des ästhetischen Resultats, des Heilungsprozesses, der Komplikations- und Rezidivrate nach Transplantation ungenetzter Spalthaut (SPHT) zur Defektdeckung nach knorpelerhaltender Resektion maligner Tumoren am Ohr. PATIENTEN UND METHODIK: 32 Patienten wurden nach Entfernung von Hauttumoren am Ohr einer Defektdeckung mittels SPHT unterzogen. ERGEBNISSE: Die durchschnittliche Defektgröße betrug 8,0 cm2 . Eine vollständige Einheilung des Transplantates erfolgte in allen Fällen innerhalb von zwei Wochen. Wesentliche Komplikationen traten nicht auf. Das ästhetische Resultat wurde sowohl von den Patienten als auch von einem Dermatochirurgen und zwei plastischen Chirurgen als gut bewertet. SCHLUSSFOLGERUNGEN: Die SPHT am Ohr ist eine zuverlässige Methode zur Deckung ausgedehnter Hautdefekte. Selbst bei großen Tumoren des äußeren Ohres ist der Ohrknorpel nicht immer infiltriert. Eine knorpelschonende Tumorresektion mit anschließender Defektdeckung mittels SPHT ist eine ausgezeichnete und rasch durchführbare Technik mit hoher Patientenzufriedenheit.

Split-thickness skin grafting for reconstruction of auricular skin defects: a statistical analysis.

BACKGROUND AND OBJECTIVES: Surgical reconstruction following the removal of large malignant auricular lesions is challenging. While many options for defect closure have been described, in the elderly population usually affected flap surgery, long anesthesia times, patient compliance, and anticoagulant therapy pose additional risks. An alternative quick, simple, and effective method of defect closure is therefore highly desirable. The objective of the present study was to assess the aesthetic outcome, healing process, complications, and recurrence rates associated with unmeshed split-thickness skin grafts (STSGs) used for covering large auricular skin defects following cartilage-sparing skin cancer removal. PATIENTS AND METHODS: Under local tumescent anesthesia, 32 patients received STSGs for defect closure following the removal of malignant cutaneous neoplasms of the ear. RESULTS: The average defect size was 8.0 cm². In all cases, complete healing of the recipient site occurred within two weeks. There were no major complications. The aesthetic outcome was rated highly by patients as well as by the dermatosurgeon involved and two independent plastic surgeons. CONCLUSIONS: STSGs are a valid option for closing large auricular skin defects. Even large cutaneous tumors of the external ear do not necessarily infiltrate the cartilage. Thus, cartilage-sparing tumor resection with subsequent defect closure using a STSG is an excellent and quick method associated with high patient satisfaction.

The "Batman flap": a novel technique to repair a large central glabellar defect.

BACKGROUND: Given the critical position of central glabella among the frontal, nasal, and supraorbital aesthetic subunits of the face, the reconstruction of large defects in this area represents a surgical challenge. METHODS: We describe a surgical technique based on a modified, curved, A-T flap to repair a large glabellar defect. RESULTS: Our modification is useful for large glabellar defects because it enables the distribution of the tension all over the reconstruction sides, avoiding a stressed central area and the subsequent risk of necrosis; functionally, it respects the eyebrows position and since the advancement is parallel to their major axes, it avoids the reduction of the distance between them. CONCLUSIONS: The "Batman flap" enables reconstructing a glabellar defect, with a good aesthetical result and the respect of the relevant aesthetical subunits.

Efficacy of a film-forming medical device containing sunscreen (50+) and piroxicam 0.8% in actinic keratosis and field cancerization: a multicenter, assessor-blinded, 3 month trial.

INTRODUCTION: Sunscreen protection in subjects with actinic keratosis (AK) is highly recommended to prevent clinical evolution of this in situ skin cancer condition. Use of topical anti-cyclooxygenase drugs such as diclofenac and piroxicam reduces the number of lesions and improves the cancerization field. A film-forming medical device in a cream formulation containing organic and inorganic sun-filters (50+ SPF) and piroxicam 0.8% (ACTX) has shown in a pilot, single-center, open trial to reduce AK lesions improving the cancerization field. AIM: We evaluated in a multicenter, assessor-blinded, 3 month trial the efficacy of ACTX in AK. METHODS: A total of 70 subjects with at least three AK lesions on the scalp or face were enrolled after written informed consent. Primary outcomes of the study were the clinical evolution of number of AK lesions on a target zone area and the evolution of dermoscopy features of the target lesion, assessing erythema, scaling, pigmentation, and follicular plug, using a 5 point score (from 0 to 4; maximum score: 16). Lesion count and dermoscopy score were evaluated in a blind fashion assessing digital color high definition coded images. A secondary outcome was the Investigator Global Score (IGS) of clinical evolution of the target area using a 7 point scale from -2 (significantly worse) to +4 (completely cured). IGS was evaluated in an open fashion. Subjects were instructed to apply the cream twice daily on the target area, using one finger-tip unit for the treatment of a 35 cm2 area. RESULTS: All but one subject (40 men and 30 women, mean age 73 years) concluded the study period. At baseline the mean (±SD) number of AK lesions in the target area were 7.0 (5.9) with a median value of 5 and the dermoscopy score of the target lesion was 7.0 (2.3) with a median value of 7.0. ACTX treatment reduced AK lesions to 3.2 (2.9), (p = .0001; Wilcoxon Test), representing a 55% relative reduction. Dermoscopy score was reduced to 3.3 (2.6) (p = .0001) (a reduction of 53%). The IGS after ACTX treatment was +1.9 (1.1), with a median of 2.0. A total of 86% of subjects showed a clinical improvement of IGS (≥1) with a very significant/complete clearance (score +3 or +4) in 42% subjects. No change or a worsening of AK lesions was observed in 14% of the subjects. The product was well tolerated. No serious adverse events were reported during the duration of the trial. CONCLUSION: In this multicenter, assessor-blinded trial, the use of a film-forming medical device with sun protection and anti-inflammatory actions was effective in reducing AK lesions and improving the dermoscopy aspect of the target lesion in 86% of treated subjects. A head-to-head trial evaluating the efficacy of this medical device in comparison with diclofenac is warranted to establish whether this therapeutic approach could offer additional advantages in term of AK lesion reduction compared to an established topical treatment. (Trial ID: ISRCTN72020277).

Prevalence and risk factors of actinic keratosis in patients attending Italian dermatology clinics.

Actinic keratosis (AK) is a common keratinocyte intra-epidermal neoplasia. To assess AK prevalence and potential risk factors in patients attending Italian general dermatology clinics. This retrospective study was conducted on clinical data from consecutive white outpatients aged ≥30 years, attending 24 general dermatology clinics between December 2014 and February 2015. AK prevalence (entire population) and multivariate risk factor analysis (patients with current/previous AK and complete data) are presented. AK prevalence in 7,284 patients was 27.4% (95% CI: 26.4-28.4%); 34.3% in men and 20.0% in women (p<0.001). Independent AK risk factors in 4,604 patients were: age (OR: 4.8 [95% CI: 3.5-6.5] for 46-60 years, increasing with older age to OR: 41.5 [95% CI: 29.5-58.2] for >70 years), history of other non-melanoma skin cancers (OR: 2.7 [2.2-3.3]), residence in southern Italy/Sardinia (OR: 2.6 [2.1-3.0]), working outdoors >6 hours/day (OR: 1.9 [1.4-2.4]), male gender (OR: 1.7 [1.4-2.0]), facial solar lentigos (OR: 1.6 [1.4-1.9]), light hair colour (OR: 1.5 [1.2-1.8]), prolonged outdoor recreational activities (OR: 1.4 [1.2-1.7]), light eye colour (OR: 1.3 [1.1-1.6]), skin type I/II (OR: 1.3 [1.1-1.6]), and alcohol consumption (OR: 1.2 [1.0-3.3]). BMI ≥25.0 (OR: 0.6 [0.5-0.7]), regular sunscreen use (OR: 0.7 [0.6-0.8]), and a lower level of education (OR: 0.8 [0.7-1.0]) were independent protective factors. AK prevalence was high in Italian dermatology outpatients. We confirm several well-known AK risk factors and reveal possible novel risk and protective factors. Our results may inform on the design and implementation of AK screening and educational programmes.