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.

Topical Corticosteroid Phobia Among Women Affected With Vulvar Lichen Sclerosus: Results From a Cross-sectional Survey.

OBJECTIVE: Topical corticosteroid (TC) phobia (TCP) is common in subjects affected with chronic inflammatory skin diseases who need prolonged corticosteroid treatments. The aim of this study was to assess TCP in women affected with vulvar lichen sclerosus (VLS). MATERIALS AND METHODS: This observational, cross-sectional study included adult patients with VLS who either started or were undergoing a TC treatment at our vulva unit between May 2022 and May 2023. All patients completed the self-administered TOPICOP questionnaire, which is validated for measuring concerns, worries, and beliefs about TC use. The scores obtained were analyzed in relation to demographic, history, and clinical data. RESULTS: The majority of the 165 (92.1%, 66.5 ± 11.9 years) included patients who had previously undergone TC treatments, mostly for VLS; 81.8% of them had received information about TCs, mainly from dermatologists (86.7%). The median global TOPICOP score was 16.7% (interquartile range. 8.3-30.6), corresponding to a raw median value of 6.0 (interquartile range, 3.0-11.0). The median subscores for the 2 TOPICOP domains, namely, mistaken beliefs and worries about TCs, were equal to each other. At multivariate analysis, none of the collected variables showed a significant association with the degree of TCP. CONCLUSIONS: In our VLS patients, TCP resulted rather low, probably because of the small skin area being treated and the high percentage of women who had already used TCs and who had received information about them from a dermatologist. This latter point suggests that adequate counseling could be a strong basis for greater awareness and serenity in the long-term use of TCs.

Searching for a "Window of Opportunity" in the Treatment of Vulvar Lichen Sclerosus: Evidence for Therapeutic Benefits of an Early Corticosteroid Treatment.

INTRODUCTION: Vulvar lichen sclerosus (VLS) is characterized by progressive anatomical changes which become increasingly severe and irreversible. The objective of this study was to investigate if a "window of opportunity" exists in VLS, i.e., to assess if an early treatment may prevent disease progression and facilitate clearance of symptoms and/or signs. METHODS: This retrospective, cohort study included VLS patients treated for the first time with a topical corticosteroid, namely with mometasone furoate 0.1% ointment, for 12 weeks (2016-2021). Scoring of subjective symptoms (global subjective score, GSS, and dyspareunia) and clinical features (global objective score [GOS] and sclerosis-scarring-atrophy) was performed at baseline (T0) and at the control visit (T1). We assessed if the achievement of clearance in GSS, GOS, sclerosis-scarring-atrophy, or dyspareunia depended on the time elapsed between VLS onset and treatment initiation. RESULTS: Among the 168 patients (59.2 ± 13.2 years) included, the median time between VLS onset and first treatment was 14.0 months. At T1, 48.8% of patients achieved clearance of GSS, 28% of GOS and 11.9% of both GSS and GOS, 57.9% of dyspareunia, and 19.2% of sclerosis-scarring-atrophy. The logistic regression model showed that each 10-month increase in treatment initiation adversely affected the clearance of GSS while starting treatment within 6 months of disease onset was significantly associated with clearance of GOS and sclerosis-scarring-atrophy. CONCLUSION: Early treatment is crucial in determining a complete healing of VLS-related symptoms and signs, especially of tissue sclerosis-scarring-atrophy, which appear poorly responsive, or even unresponsive, after the earliest stages of the disease. Thus our findings provide evidence for a "window of opportunity" in VLS treatment.

Does Clearance of Vulvar Lichen Sclerosus after a Corticosteroid Treatment Correspond to a Decrease in Disease-Related Burden? Results from a Cohort Study Using Pictorial Representation of Illness and Self-Measure and the Dermatology Life Quality Index.

BACKGROUND AND OBJECTIVES: Complete clearance of vulvar lichen sclerosus (VLS) occurs in a minority of treated patients. Disease persistence may impact patient well-being. The main objective of this study was to assess if achieving a complete clearance with a corticosteroid treatment leads to a benefit in terms of patient suffering and quality-of-life (QoL) impairment. METHODS: We performed an observational study on a cohort of VLS women, who applied mometasone furoate 0.1% ointment for 12 weeks. At treatment completion (T1), we compared the patients who achieved clearance in symptoms (Global Subjective Score [GSS] = 0) or in objective features (Global Objective Score [GOS] = 0) or in both with those who achieved a lower degree of improvement, on the basis of Pictorial Representation of Illness and Self-Measure (PRISM) and Dermatology Life Quality Index (DLQI) scores. RESULTS: In the whole sample (n = 101), GSS, GOS, PRISM, and DLQI scores significantly improved after treatment from baseline; 34 patients (35.8%) achieved GSS = 0, 26 (25.7%) achieved GOS = 0, and 11 (11.5%) clearance of GSS and GOS. PRISM scores at T1 were significantly higher in patients who achieved clearance of symptoms when compared with those who did not, including patients achieving 50-99% GSS improvement from baseline. DLQI scores were lower in patients who achieved clearance of symptoms, signs, or both when compared with the others. CONCLUSIONS: VLS clearance corresponded to a significant improvement in the QoL of VLS patients, also in comparison with those who achieved a substantial but incomplete decrease of symptom and sign scores, and should become an ideal therapeutic goal.

Proposal of a self-assessment questionnaire for the diagnosis of sensitive skin.

BACKGROUND: Sensitive skin is very common and distressing. Its diagnosis may be difficult with the tools/methods available at the moment. AIMS: To assess the reliability of a self-assessment questionnaire for the diagnosis of sensitive skin, using the results of lactic acid stinging test (LAST) as a reference for the identification of subjects suffering from this condition. A further objective was to identify the questionnaire cutoff score that better discriminates between subjects with or without sensitive skin. PATIENTS/METHODS: Among the adult volunteers included in this observational, cross-sectional study, both LAST-positive subjects, who were considered as having sensitive skin ("patients"), and negative ones ("controls") completed the questionnaire. It consisted of a part for self-assessing and quantifying (0-10) sensitive skin and another one that included 10 items, each referring to a specific, potentially triggering stimulus. A cumulative score (questionnaire-based skin sensitivity score, 0-10) was calculated from the sum of all items considered capable of triggering unpleasant skin sensations in real-life experience. RESULTS: One hundred and sixty-two subjects were enrolled, 102 patients and 60 controls; 98 subjects thought they had sensitive skin. The mean questionnaire-based skin sensitivity score was significantly higher among patients than controls and correlated with skin sensitivity self-assessments. A cutoff value of 3 was set for the identification of LAST-positive subjects, with 79% accuracy. CONCLUSIONS: The study self-assessment questionnaire seems to be a reliable tool for diagnosing sensitive skin in clinical practice. These results led us to identify a numerical cutoff for detecting propensity to experience sensitive skin.

Does longer duration of corticosteroid treatment improve clearance in vulvar lichen sclerosus? Results from a single centre, comparative, open label study.

A complete clearance of vulvar lichen sclerosus (VLS) is achieved in a minority of patients treated with a standard 12-week duration corticosteroid treatment. The aim of this pragmatic, retrospective, open label, comparative trial was to assess the effectiveness, in terms of complete clearance, of a 24-week treatment with mometasone furoate 0.1% ointment (MMF) and to compare it with a 12-week therapy. We included VLS patients treated with MMF administered for five consecutive days/week for 24 weeks (group A). The following were assessed: (a) clearance in Global Subjective Score (GSS), Global Objective Score (GOS) or both, (b) changes of these parameters and dyspareunia at treatment completion compared to baseline, (c) safety profile. All these assessments were compared with the same outcomes recorded among VLS patients who had previously undergone a 12-week MMF treatment (group B). Twenty-nine patients were included in group A and 32 in group B. The rates of patients who achieved the clearance of GSS, GOS or both parameters did not significantly differ between groups A and B. The groups did not differ in any of the effectiveness outcomes assessed. A 24-week duration corticosteroid treatment does not seem to provide significant therapeutic benefits in comparison with standard 12-week courses, especially considering the occurrence of complete clearance.

Patch test reactions through the lens of dermoscopy: Further insights, particularly on weak allergic reactions.

BACKGROUND: Distinguishing weak allergic reactions from irritant patch test reactions may be difficult. OBJECTIVES: To describe the dermoscopic features of allergic reactions (especially weak allergic ones) and irritant patch test reactions, and to assess the suitability of dermoscopy in supporting differential diagnosis. METHODS: Eligible participants for this observational, cross-sectional study included consecutive adult outpatients patch tested during a 12-month period, who developed any skin reaction. Healthy volunteers were patch tested with sodium lauryl sulfate as irritant controls. At the 72-hour reading, patch test reactions were recorded both with a digital camera and a digital dermoscopic system. For each reaction, clinical and dermoscopic variables were separately assessed, scored, and then compared. RESULTS: Erythema, vessels, and vesiculation were constant dermoscopic features of allergic reactions (n = 173). In 46 weak (+) allergic reactions, dermoscopy showed (a) erythema (100%), (b) dense polymorphic vessels (100%), and (c) whitish vesicles (78.3%). Scores for vesicles and dotted vessels were significantly higher in weak allergic than in irritant reactions. Vesicles were identified as the chief dermoscopic parameter for correctly distinguishing weak allergic from irritant reactions. CONCLUSIONS: Dermoscopy can improve accuracy in the differential diagnosis between weak allergic and irritant patch test reactions.

Combining topical tretinoin with mometasone furoate in the treatment of vulvar lichen sclerosus: Results of dermoscopic assessment.

The main purpose of the present study was to compare the dermoscopic changes on vulvar lichen sclerosus (VLS) induced by two different 12-week treatment protocols, namely mometasone furoate 0.1% ointment plus tretinoin 0.05% cream in short-contact therapy (group A) versus the same corticosteroid plus emollient (group B). All dermoscopic images captured before and after treatment were assessed. Each dermoscopic variable selected for the study purpose was arbitrarily graded according to a 4-point scale by dermatologists blinded to both the time at which the images were captured and treatment allocation. Seventeen patients in group A and 15 in group B were included. The vessel mean dermoscopic scores increased significantly after treatment, whereas the scores of (a) patchy, structure-less, whitish areas, (b) whitish background, (c) comedo-like openings, and (d) purpuric blotches decreased. At the control visit, the two protocols did not differ significantly for any of the dermoscopic parameters, both in terms of mean score change and in the number of patients showing changes. Although the complementary action of the two molecules may suggest a therapeutic benefit, the association of tretinoin in short contact therapy with a potent corticosteroid did not induce significant changes in the dermoscopic features of VLS compared with the same corticosteroid alone.

Mometasone furoate in the treatment of vulvar lichen sclerosus: could its formulation influence efficacy, tolerability and adherence to treatment?

PURPOSE: To assess the effectiveness, tolerability, and convenience of the cream formulation of mometasone furoate 0.1% (MMF) in the treatment of active vulvar lichen sclerosus (VLS) and to compare the cream with the ointment formulation. METHODS: The following efficacy parameters were assessed in 27 VLS patients treated with MMF cream for 12 weeks (group A): (i) response rate, (ii) percentage of patients achieving an improvement from baseline of ≥75% in subjective and objective scores, and (iii) mean reduction in subjective and objective scores. These efficacy assessments, as well as those regarding safety and adherence, were compared with the assessments recorded among 37 VLS patients treated with MMF ointment (group B). RESULTS: 59.3% (group A) and 78.4% (group B) of patients were considered responders; 44.4% and 40.7% of patients in group A and 54.1% and 45.9% in group B achieved an improvement of at least 75% in subjective and objective scores, respectively. MMF ointment obtained a significantly higher improvement in symptom scores in comparison with the cream formulation. CONCLUSIONS: MMF in ointment formulation seems to be more effective in treating active VLS in comparison with MMF cream. Both formulations are well tolerated and there is no difference in patient adherence and satisfaction.