Efficacy and tolerability of tirbanibulin 1% ointment in the treatment of cancerization field: a real-life Italian multicenter observational study of 250 patients.

BACKGROUND: Tirbanibulin 1% ointment is approved for the field treatment of Olsen grade I actinic keratoses (AKs) of the face and scalp. METHODS: We performed a multicenter retrospective study involving 15 dermatologic units in Italy to investigate the efficacy and tolerability of tirbanibulin in a real-life setting. 250 patients were enrolled. Tirbanibulin, 1% ointment, was applied daily for five consecutive days. The efficacy of treatment was measured with modifications of the Actinic Keratosis Area and Severity Index (AKASI). A satisfactory response was defined by complete (100% reduction in the number of lesions) or partial clearance (75-99%) of treated AKs. RESULTS: Overall, the AKASI score was significantly reduced in the studied population (mean, from 4.1 ± 2.7 to 1.4 ± 1.5; P < 0.001). A satisfactory response was observed in 222 (88.8%) cases. The proportion of satisfactory responses was higher when follow-up was performed after 8 weeks (34/35, 97.1%). The reduction in AKASI was significant in patients with Olsen grade II or III lesions (from 5.3 ± 2.8 to 1.6 ± 1.6; P < 0.001). A satisfactory response was observed in 91/104 (87.5%) cases. AKASI reduction was also significant in patients with trunk or limb AKs (from 7.0 ± 1.3 to 2.0 ± 1.6; P = 0.018) since a satisfactory response was observed in 7/8 (87.5%) cases. Tirbanibulin was well tolerated; all adverse events (AEs) included transient local reactions at the site of treatment. Overall, 231 patients had at least one AE. Only 7 (2.8%) grade 4 AEs were recorded. CONCLUSION: Our retrospective study confirmed that tirbanibulin 1% ointment is effective and well tolerated in a real-life setting and is also promising for Olsen grade II and grade III AKs and AKs localized on difficult-to-treat areas.

Facial atopic dermatitis may be exacerbated by masks: insights from a multicenter, teledermatology, prospective study during COVID-19 pandemic.

BACKGROUND: Patients with atopic dermatitis (AD) display a defective skin barrier, consequently they may experience inflammatory flares with different exposures, including masks. Actually, beside scattering case reports, no study focused on the possible AD flaring due to masks. METHODS: In this multicenter prospective study AD patients with facial manifestation were followed with teledermatology and evaluated by two board-certified dermatologists at the baseline (T0) and after 1 month (T1) in which patients started to wear masks >6 hours per day. Demographics and clinical parameters, included and not limited to Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI), were carefully collected and analyzed. RESULTS: We enrolled 57 AD patients (M/F 28/29, 33.91±12.26 years old) that wore surgical masks (38 [66.7%]), community masks (11 [19.3%] and N95 (8 [14.0%]). Both DLQI and EASI increase during the time period (P<0.0001). DLQI variation was not influenced by age, BMI, and gender, mask type used and AD therapy (P=0.99), whilst EASI variation was significantly influenced by BMI, gender, and therapy (P=0.004). CONCLUSIONS: Mask wearing may prove detrimental to patients with atopic eczema and the same may not necessarily be the case for asthma patients.

Masks trigger facial seborrheic dermatitis and psoriasis: evidence from a multicenter, case-control study during COVID-19 pandemic.

BACKGROUND: Wearing masks is an optimal preventive strategy during COVID-19 pandemic, but it may increase facial sebum production. However, few case reports have described seborrheic dermatitis (SeBD) and psoriasis (PsO) flares due to masks. Hence, we conducted a multicenter study to clarify the possibility of increased SeBD and PsO flares in association with mask wearing during the COVID-19 pandemic. METHODS: This multicenter study enrolled patients with a diagnosis of facial SeBD and PsO. All dermatological consultations were conducted in teledermatology at baseline (T0) and after 1 month (T1) Of >6 hours/day wearing mask. PsO patients were assessed using PsO Area and Severity Index (PASI) and self-administered PASI (SAPASI), whilst SeBD patients with symptom scale of seborrheic dermatitis' (SSSD) and seborrheic dermatitis area and severity index (SEDASI). RESULTS: A total of 33 (20 males, 13 females, average age 43.61±9.86) patients with PsO and 33 (20 males, 13 females, average age 44.00±8.58) with SeBD were enrolled. After 1 month, PsO patients displayed higher values of both PASI and SAPASI (P<0.0001), while SeBD patients experienced a flare, as testified by the increment of both SSSD and SEDASI (P<0.0001). Mask type did not seem to influence the flare severity. CONCLUSIONS: Masks remain an optimal preventive strategy during COVID-19 pandemic, but patients with PsO and SeBD may experience facial flares. Thus, therapeutic approach should be more aggressive in these groups of patients to counteract the triggering effect of masks.

COVID-19 first lockdown and outpatient hospital setting: a single center, real life study focusing on pattern changes in patients' ethnicities and treated dermatoses.

BACKGROUND: During the first Italian lockdown period, the imponent amount of hospital COVID-19 patients forced the healthcare system to re-organize visits but no information are available on outpatient ethnical patterns. Here we evaluated healthcare management changes on dermatological outpatient non-surgical settings visits during the SARS-CoV-2 pandemic. METHODS: In this retrospective study we collected data of scheduled, performed and not-performed visits, together with patients' characteristics (i.e., age, gender) with a particular attention for ethnicities among the outpatients accessing during the first Italian lockdown (March 5-April 30, 2020). Then, we compared these data with the corresponding ones in 2019 (before COVID-19 pandemic). RESULTS: During the Italian lockdown the dermatological department registered a great decrement (-83.5%, P<0.001) in visits compared to the corresponding time period in 2019. Performed and scheduled visits to non-oncological stable patients together with emergency accesses to dermatology decreased. Non-Italian patients decreased accesses, especially the South East Asians (-70.4%) and North Africans (-90.0%). CONCLUSIONS: Hospitals policy and mass media deeply condition the public opinion, and this aspect may explain a different access to the hospital among non-Italian patients. Telemedicine should be promoted especially among non-Italian communities in Italy to overgo patients' skepticism and incentivize prevention and early treatment in dermatological conditions.

Nicotinamide Attenuates UV-Induced Stress Damage in Human Primary Keratinocytes from Cancerization Fields.

UVB radiation directly damages DNA, increases ROS and nitric oxide (NO) release, and promotes inflammation leading to genomic instability and cell death. Nicotinamide (NAM) is the precursor of NAM adenine dinucleotide, essential for cell energy production and DNA damage repair. NAM protects HaCat cells from UV-induced impairment; however, little is known about its effects on human primary keratinocytes and those isolated from field cancerization (i.e., field cancerization human primary keratinocytes [FC-HPKs]). We examined the role of NAM against UV-induced oxidative stress damages in FC-HPKs, isolated from precancerous lesions and skin cancers, and in normal human epidermal keratinocytes. Cells were treated for 18, 24, and 48 hours with NAM (5, 25, and 50 µM, respectively) before UVB irradiation. FC-HPK showed four-fold higher basal ROS levels than normal human epidermal keratinocytes; NAM downregulated ROS production only in irradiated FC-HPKs, which showed a greater sensibility to UV rays. UV exposure increased OGG1, inducible nitric oxide synthase, and IL-1ß expression, an effect counteracted by NAM pretreatment. Intracellular nitric oxide production and DNA damages were inhibited by NAM exposure before irradiation. Collectively, our findings indicate that pretreatment with 25 µM NAM 24 hours before UVB irradiation effectively prevents oxidative stress formation, DNA damage, and inflammation in both normal human epidermal keratinocytes and FC-HPKs.

Masks use and facial dermatitis during COVID-19 outbreak: is there a difference between CE and non-CE approved masks? Multi-center, real-life data from a large Italian cohort.

BACKGROUND: During the recent COVID-19 outbreak, masks became mandatory and shortages frequent, therefore the prevalence of non-CE (European Conformity Mark) approved masks increased in the general population. We aimed to quantify the prevalence of mask-related cutaneous side effects and the differences between CE and non-CE approved masks. METHODS: In this multicenter prospective observational study conducted from March 20, 2020 to May 12, 2020(during and after quarantine), patients attending emergency departments for a dermatological consult were clinically assessed and their masks were inspected to detect CE marks and UNI (Italian National Unification Entity) norms. Patients with history of facial dermatoses or under current treatment for facial dermatoses were excluded. RESULTS: We enrolled 412 patients (318 during quarantine and 94 after quarantine). CE-approved masks were observed 52.8% vs. 24.5%, whilst subsets of non-CE approved masks were 9.7% vs. 14.9% (Personal protective equipment (PPE)-masks), 16.4% vs. 12.8% (surgical masks [SM]), and 21.1% vs. 47.9%(non-PPE) and (non-SM masks), respectively during and after quarantine. Remarkably, non-CE-approved masks resulted in patients displaying a statistically significant higher incidence of facial dermatoses and irritant contact dermatitis compared to CE-approved masks, and these differences were mainly driven by non-PPE non-SM masks. Comparing quarantine and after quarantine periods, no statistically significant differences were found for CE-approved masks, whilst differences were detected in non-CE-approved masks regarding incidence of facial dermatoses (P<0.0001)and irritant contact dermatitis (P=0.0041). CONCLUSIONS: Masks are essential to prevent COVID-19 but at the same time higher awareness regarding mask specifications should be promoted in the general population. Non-PPE and non-SM masks should undergo more rigorous testing to prevent the occurrence of cutaneous side effects and future patients' lawsuit damages.

COVID-19 related masks increase severity of both acne (maskne) and rosacea (mask rosacea): Multi-center, real-life, telemedical, and observational prospective study.

Masks are essential for COVID-19 prevention, but recently they were suggested to modify cutaneous facial microenvironment and trigger facial dermatoses. To evaluate mask-related rosacea and acne (maskne) in untreated patients during lockdown. In this multi-center, real-life, observational prospective study, we enrolled stable, untreated acne and rosacea patients that wore masks during lockdown at least 6 h/day. They underwent two teledermatological consultations, at the baseline and after 6 weeks. Clinical, pharmacological, and psychological data were recorded. A total 66 patients, 30 (median age: 34.0 [30.25-29.75] yoa) with acne and 36 patients (median age: 48 [43-54] years) with rosacea, were enrolled in this study. After 6 weeks of mask and quarantine, patients with acne displayed an increased Global Acne Grading Scale (GAGS) score in mask-related areas (P < .0001). Likewise, after 6 weeks of mask and quarantine, patients with rosacea displayed a worsen in both physican (P < .0001) and patient (P < .0001) reported outcomes. Remarkably, patients reported also a statistically significant decrease in their quality of life (P < .0001). Masks appear to trigger both acne and rosacea flares. Additional studies are needed to generate evidence and inform clinical decision-making.

Rapid and exceptional response to Sonidegib in a patient with multiple locally advanced basal cell carcinomas.

Locally advanced basal cell carcinoma (laBCC) represents a rare but possible occurrence in the vast scenario of dermatological diseases. It is well known that most BCC has a pathological activation of the hedgehog pathway, making them susceptible to targeted therapy with selective inhibitors. Sonidegib, approved for the treatment of laBCC on the basis of the results of the basal cell carcinoma outcomes with LDE225 treatment study, demonstrated rapid efficacy and a manageable safety profile. Here, we describe the case of a patient affected by multiple laBCC treated with Sonidegib. The patient experienced an important regression of tumors after only 2 months of therapy, with few side effects. This result confirms the role of Sonidegib as a valid and well-tolerated therapeutic option for laBCC.

Reconstruction of scalp defects with exposed bone after surgical treatment of basal cell carcinoma: the use of a bilayer matrix wound dressing.

Treatment of scalp defects after tumor resection or traumatic events is a challenging problem. Large defects with loss of soft tissue down to the bone require complex reconstructive options, including tissue expansion, local and distal scalp flaps, and free split thickness skin graft. Nonetheless, these techniques are often disfiguring and are limited by the relatively poor elasticity and vascularity of scalp tissues after recurrent resection or previous irradiation. Moreover, comorbid conditions among elderly patients often limit anesthetic tolerance and the use of distant flaps. We report a case of a 75-year-old woman with large tissue loss and bone exposure after Mohs micrographic surgery of basal cell carcinoma of the scalp which was successfully rebuilt through the use of a skin substitute. We describe the uncommon use of a bilayer matrix wound dressing as a single procedure option for the management of full-thickness scalp defects with bone exposure.