Italian National Registry of Alopecia Areata: an epidemiological study of 699 Italian patients.

BACKGROUND: Alopecia areata (AA) is an organ-specific autoimmune disease that affects the hair follicles of the scalp and the rest of the body causing hair loss. Due to the unpredictable course of AA and the different degrees of severity of hair loss, only a few well-designed clinical studies with a low number of patients are available. Also, there is no specific cure, but topical and systemic anti-inflammatory and immune system suppressant drugs are used for treatment. The need to create a global registry of AA, comparable and reproducible in all countries, has recently emerged. An Italian multicentric electronic registry is proposed as a model to facilitate and guide the recording of epidemiological and clinical data and to monitor the introduction of new therapies in patients with AA. METHODS: The aim of this study was to evaluate the epidemiological data of patients with AA by collecting detailed information on the course of the disease, associated diseases, concomitant and previous events, and the clinical response to traditional treatments. Estimate the impact on the quality of life of patients. RESULTS: The creation of the National Register of AA has proven to be a valid tool for recording, with a standardized approach, epidemiological data, the trend of AA, response to therapies and quality of life. CONCLUSIONS: AA is confirmed as a difficult hair disease to manage due to its unpredictable course and, in most cases, its chronic-relapsing course, capable of having a significant impact on the quality of life of patients.

Topical prebiotics/postbiotics and PRURISCORE validation in atopic dermatitis. International study of 396 patients.

Aim: To investigate the efficacy and tolerability of a cream (Rilastil Xerolact PB) containing a mixture of prebiotics and postbiotics, and to validate the PRURISCORE itch scale in the management of atopic dermatitis.Methods: The study is based on 396 subjects of both sexes in three age groups (i.e., infants, children, adults) suffering from mild/moderate Atopic Dermatitis, recruited from 8 European countries and followed for 3 months.Results: The product demonstrated good efficacy combined with good/very good tolerability in all age groups. In particular, SCORAD, PRURISCORE and IGA scores decreased significantly over the course of the study. The PRURISCORE was preferred to VAS by the vast majority of patients.Conclusion: Even though the role of prebiotics and postbiotics was not formally demonstrated since these substances were part of a complex formulation, it can be reasonably stated that prebiotics and postbiotics have safety and standardization features that probiotics do not have. In addition they are authorized by regulatory authorities, whereas topical probiotics are not.

Advances in pharmacotherapy for rosacea: what is the current state of the art?

INTRODUCTION: Rosacea is a chronic and relapsing facial dermatosis that encompasses a wide spectrum of clinical phenotypes (transient/persistent erythema, telangiectasias, papules/pustules, edema, phymatous changes, and ocular symptoms) often with uncomfortable symptoms such as flushing, pain, burning, edema, and dryness. Current pharmacological treatment includes topical agents, spanning from several conventional (azelaic acid, metronidazole, sodium sulfacetamide) to new ones (brimonidine, oxymetazoline, ivermectine, minocycline), and systemic agents (doxycycline 40 mg modified-release), all Food and Drug Administration approved. AREAS COVERED: The aim of our article is to review the state of art of pharmacological treatment, either as monotherapy or in combination therapy, tailored to the most common rosacea phenotypes (persistent erythema, inflammatory papules/pustules). Other off-label topical or systemic drugs and several adjuvant phytotherapeutic agents are considered. EXPERT OPINION: Combined therapies to target different phenotypes, when present in the same patient, represent one of the major achievements in the management of vascular and inflammatory papules and pustules of rosacea. Future investigations should be addressed to early inflammatory phyma or ocular rosacea, which have actually been neglected. Finally, there is still an ongoing need for therapeutic interventions able to relieve symptoms and social burden, all factors that greatly contribute to improve rosacea quality of life.

An Overview of the Diagnosis and Management of Seborrheic Dermatitis.

Seborrheic dermatitis (SD) is a common chronic inflammatory skin disorder that mostly affects young adults in areas rich in sebaceous glands (scalp, face, and trunk). In adolescents and adults, SD clinical presentation may range from mild patches to diffuse scalp scaling. In infants, it mainly occurs on the scalp as yellowish, scaly patches ("cradle cap"). In adults, several environmental triggers are likely to promote SD development, along with fungal colonization by Malassezia spp., sebaceous gland activity, as well as immunosuppression, endocrine, neurogenic and iatrogenic factors. In children, early occurrence in the first trimester suggests the role of excessive sebaceous gland activity from maternal hormones, along with cutaneous microbiome alterations. The diagnosis of SD is usually clinical, and specific laboratory and/or instrumental investigations are seldom required. Treatment is aimed at modulating sebum production, reducing skin colonization by Malassezia spp., and controlling inflammation. In adults, mild-to-moderate scalp SD forms can be managed with topical antifungals (ketoconazole, ciclopirox, miconazole) or antiinflammatory (mild-to-moderate potency corticosteroids) or keratolytic/humectant (propylene glycol) agents. Recommended topical therapeutic options for mild-to-moderate facial or body areas SD include topical ketoconazole, ciclopirox, clotrimazole, mild-to-moderate potency corticosteroids, lithium succinate/gluconate, and topical calcineurin inihibitors (off-label use). In severe and/or resistant cases, the use of systemic antifungal drugs (terbinafine, itraconazole), as well as UVB phototherapy, may be considered. In children, scant scientific evidence supports the effectiveness and safety of topical drugs, and "cradle cap" is usually successfully managed with baby shampoos enriched with emollient agents and vegetable oils. Alternatively, similarly to adult scalp SD, medical device shampoos with antiinflammatory and antifungal properties, containing piroctone olamine, bisabolol, alyglicera, telmesteine, may be used. Beyond pharmacological treatments, an appropriate cosmetic approach, if correctly prescribed, may improve therapeutic outcomes.

Home treatment of single cutaneous warts combining face-to-face and teledermatology consultation: A new perspective.

During the COVID-19 pandemic, teledermatology services were set up and enhanced to take care of those benign conditions like cutaneous warts (CWs) which, if undiagnosed or treated with delay, could have worsened, enlarged, and potentially spread to the community. The aim of this hybrid exploratory trial was to combine face-to-face clinical and dermoscopic evaluation with teledermatology follow-up in the management of CWs with a cryogenic pen based on nitrous oxide for home treatment. Twelve adult patients affected by CWs were enrolled. During the first face-to-face visit, single CWs were selected for the study by clinical and dermoscopic evaluation. The home schedule consisted of one application to be repeated after 2 weeks, when signs of CWs were still evident. Patients were also asked to send a clinical photo of the treated lesion at weekly intervals. A final face-to-face evaluation was scheduled to verify the response to home treatment by clinical and dermoscopy evaluation. A total of 20 CWs located on the trunk and the extremities were treated: a complete clinical and dermoscopic resolution was observed in 16 out of 20 lesions (80%), and a partial response in two cases. The adverse events observed during treatment were comparable to those normally observed with cryotherapy of CWs. In conclusion, home treatment of CWs with the cryogenic pen, that should be always preceded by dermatologist diagnosis and prescription, is safe and effective, especially if combined with face-to-face and teledermatology consultations, pointing out its important role during pandemic times or in any other environmental limitations that may impair the access to medical care services. The combination of face-to-face consultations for initial and final visits and teledermatology during the treatment phase could represent a model for other dermatologic conditions as well (e.g., acne, rosacea, psoriasis, atopic eczema etc.).

Intrafamilial Transmission of Rosacea Spanning Six Generations: A Retrospective Observational Study.

Rosacea hereditary predisposition has been hypothesized based on family inheritance and twin concordance. Currently, information concerning intrafamilial rosacea transmission are still limited to few generations. The aim of our study was to assess data on rosacea intrafamilial transmission spanning six generations. One-hundred and thirty patients affected by rosacea who visited our acne and rosacea clinic from June 2018 to June 2019 were consecutively enrolled in this study. During clinical evaluation, an accurate anamnesis, including familiarity across six generations, which included vertical, horizontal, and combined transmission, was performed. Affected relatives were clinically evaluated, and in those in which clinical consultation was not feasible, clinical photos were obtained. The results showed that 64 of 130 patients (49.2%) were positive for at least a family member with rosacea. In addition, 90 affected relatives (69.2%) were identified by extending the familial investigation to the whole kindred, finding a percentage of familiarity (69.2%) higher than that reported in the literature (30-50%) with a 1:1.4. ratio of patients positive for familiarity/affected relative. Our study contributes to add knowledge about intrafamilial involvement in rosacea. Extending the search to all potential affected parents and offspring of rosacea patients can promote early diagnosis along with the adoption of correct therapeutic interventions and educational programs to prevent the exposure to triggering or exacerbating factors.

A novel treatment of intertrigo in athletes and overweight subjects.

BACKGROUND: Intertrigo is a recurrent inflammatory dermatosis involving large/small body folds. Skin barrier products represent the mainstay of treatment in uncomplicated mild/moderate intertrigo. AIMS: To assess by clinical and instrumental evaluation the efficacy and tolerability of a new barrier spray containing zinc gluconate-taurine complex and zinc oxide combined with panthenol, glycerin, and Shea (Butyrospermum parkii) butter in mild-to-moderate intertrigo in athletes and overweight subjects. METHODS: In this open-label prospective trial, 20 adult patients, with mild/moderate intertrigo enrolled at the Dermatology University Clinic of Catania (Italy), were instructed to apply the spray twice daily for 30 days. Degree of erythema was performed clinically and by polarized dermoscopy using a 5-point severity scale (from 0=no erythema to 4=severe erythema) at baseline, and at 15 and 30 days. The measurement of pruritus was carried out by a subject-completed visual analog scale (VAS) (from 0 mm=no pruritus to 100 mm=severe pruritus), at all time points. An Investigator Global Assessment (IGA) using a 6-point scale (from -1=worsening to 4=complete response/clear) was also conducted at 30 days, along with a self-administered tolerability questionnaire. Statistical analysis was performed using SAS version 9. RESULTS: At 15 days, a statically significant reduction from baseline in erythema severity (mean from 3.4 ± 0.3 to 2.5 ± 0.2) along with pruritus intensity (mean from 70 ± 15.4 mm to 40 ± 9.5 mm) was observed. At 30 days, all evaluated parameters showed a further progressive statistically significant reduction from baseline. No relevant side effects were recorded. CONCLUSIONS: Our results suggest that the tested spay containing antiseptic/anti-inflammatory and anti-irritation agents may represent a valid therapeutic option for mild/moderate intertrigo.

Treatment of cradle cap in infants with a new cosmetic non-steroidal gel cream: Clinical, laboratory, and instrumental evaluation.

BACKGROUND: Cradle cap is a benign and self-limiting variant of seborrheic dermatitis (SD) that can be distressing for parents. AIMS: To assess by clinical/laboratory/instrumental evaluation the efficacy/tolerability of a gel cream containing piroctone olamine (antifungal), biosaccharide gum-2 (antifungal), stearyl glycyrrhetinate (anti-inflammatory), and zinc l-pyrrolidone carboxylate (zinc-PCA) (antiseborrheic) in the treatment of mild/ moderate cradle cap. METHODS: In this prospective, open-label trial, 10 infants, with mild/moderate cradle cap enrolled at the Dermatology University Clinic of Catania (Italy) used the tested gel cream twice daily for 30 days. Degree of erythema was evaluated clinically by a 5-point severity scale (from 0=no erythema to 4=severe erythema), at baseline, at 15 and 30 days. Desquamation was rated by dermoscopy evaluation using a 5-point scale (from 0=no desquamation to 4=severe/many large adherent white flakes), at all time points. An Investigator Global Assessment (IGA) using a 6-point scale (from -1=worsening to 4=complete response/clear) was also performed at 30 days. Five subjects, randomly selected, underwent double microbiological evaluation for bacteria and yeasts by cultures of cotton swabs at baseline and at 30 days. Tolerability/acceptability was evaluated on a 4-point scale (from 0=very poor to 3=excellent) at 15 and 30 days. Data were processed using SAS version 9. RESULTS: At baseline, a significant colony-forming unit (CFU) count for Malassezia furfur and Staphylococcus aureus was detected in 4 out of 5 selected patients. After 15 and 30 days, a statically significant reduction from baseline in erythema and desquamation severity was observed, along with a reduction in CFU count for Malassezia furfur and Staphylococcus aureus from baseline. No signs of local side effects were documented. CONCLUSIONS: Our results indicate that the tested gel cream may represent a valid option to treat mild-to-moderate forms of cradle cap and support its antifungal and antibacterial properties.

A novel azelaic acid formulation for the topical treatment of inflammatory rosacea: A multicentre, prospective clinical trial.

BACKGROUND: Topical azelaic acid (AzA) is a common treatment for mild/moderate inflammatory rosacea. AIMS: To assess the efficacy and tolerability of a novel formulation cream containing 15% AzA (anti-inflammatory/anti-oxidant/anti-microbial agent) combined with 1% dihydroavenanthramide D (anti-inflammatory/anti-itch) in inflammatory rosacea using clinical/instrumental evaluation. METHODS: In this multicentre, prospective, open-label trial, 45 patients with mild/moderate inflammatory rosacea enrolled at the Dermatology Clinic of the University of Catania, Naples, and Rome (Italy) were instructed to apply the cream twice daily for 8 weeks. Clinical evaluation was performed at baseline (T0) and at 8 weeks (T1) by (1) Investigator Global Assessment (IGA) score based on a 5-point scale (from 0 = clear/no erythema/papules/pustules to 4 = severe erythema/several papules/pustules) and (2) inflammatory lesions count. Instrumental evaluation of erythema degree was performed by erythema-directed digital photography (EDDP) by a 5-point scale (from 0 = no redness to 4 = severe redness) at all time points. Tolerability was assessed by a self-administered questionnaire at 8 weeks. Statistical analysis was performed using SAS version 9. RESULTS: Forty-four patients completed the study. At week 8, a significant decrease in baseline of IGA scores [median from 3 (T0) to 1 (T1)] and inflammatory lesions count [median from 8 (T0) to 1 (T1)] was recorded along with a significant reduction of erythema scores [median from 2 (T0) to 1 (T1)]. No relevant side effects were recorded. CONCLUSIONS: Our results suggest that this new non-irritating product represents a valid therapeutic option for mild/moderate inflammatory rosacea, and EDDP is able to provide a more defined evaluation of erythema changes.

A novel treatment of diaper dermatitis in children and adults.

BACKGROUND: Diaper dermatitis (DD) is an acute inflammatory reaction, regardless of the cause, of the diaper-covered area. Topical skin barrier repair cosmetic products are the mainstay treatment to cure and/or prevent DD. AIMS: To assess the efficacy/tolerability of a zinc gluconate-taurine/zinc oxide and panthenol/ glycerin/ Butyrospermum parkii butter barrier cream using clinical evaluation. METHODS: In this prospective, open-label trial, 20 patients (10 infants/10 adults), with mild/moderate DD enrolled at the Dermatology University Clinic of Catania (Italy) were instructed to apply the cream twice daily for 30 days. Degree of erythema was performed clinically by a 5-point severity scale (from 0 = no erythema to 4 = severe erythema), at baseline, at 15 and 30 days. An Investigator Global Assessment (IGA) using a 6-point scale (from -1 = worsening to 4 = complete response/clear) along with product tolerability was also performed at 15 and 30 days. Statistical analysis was performed using SAS version 9. RESULTS: At 15 days, a reduction of clinical erythema assessment (CEA) from baseline was observed (mean from 3.2 ± 0.8 to 2.5 ± 0.3; p < 0.06), that although nonsignificant, showed a significant progressive improvement at 30 days (mean from 3.2 ± 0.8 to 1.1 ± 0.9; p < 0.0001) without any age differences. CONCLUSIONS: Our preliminary results indicate that the tested barrier cream may represent a promising approach in DD rash. It may be used in mild-to-moderate forms in monotherapy without significant side effects or, where required, in association with pharmacological agents. Its long-term use is likely safe.

Emerging topical drugs for the treatment of rosacea.

Introduction: Rosacea is a common, chronic and relapsing inflammatory skin disease of the centrofacial area. Despite advancing knowledge on its pathogenesis, diagnosis, and treatment, some major unknowns still remain, including systematic evidence-based guidelines useful both for clinical assessment and therapeutic management. Topical treatment is regarded as a first-line option for mild to moderate rosacea and includes traditional and new FDA-approved prescription drugs, as well as off-label alternative topical agents.Areas covered: Since improved awareness of rosacea pathogenetic mechanisms has led to the development of new potential therapeutic agents, a search was performed on the ClinicalTrial.gov registry. The results identified several investigational topical drugs able to target one or more of the pathogenetic factors of rosacea.Expert opinion: The main unmet needs in the topical treatment of rosacea remain the management of vasomotor flushes and telangiectasias, as well as of troublesome symptoms such as burning and/or stinging. No single agent effective on all rosacea phenotypes is available so far, and preventive treatments capable of halting disease progression have not been identified yet. Finally, data on long-term efficacy and tolerability are still incomplete, especially for drugs more recently introduced in the market.

Erythema-directed digital photography and colorimeter scores correlate with rosacea erythema evaluation in patients under treatment with topical ivermectin.

Inflammatory rosacea is clinically characterized by persistent erythema and inflammatory lesions. Its severity is generally based on clinical observation that may be cumbersome. The aim of this study was to assess if erythema-directed digital photography (EEDP) and colorimeter (COL) correlate and are concordant with clinical evaluation of erythema degree of rosacea under topical treatment. Thirty naïve patients with mild/moderate inflammatory rosacea were instructed to apply ivermectin cream for 8 weeks. Erythema degree was performed at baseline, and at 2, 4, 6, and 8 weeks by clinician erythema assessment based on 5-point severity scale (from 0 = no erythema to 4 = fiery redness), and by instrumental evaluation by EDDP using the same 5-point scale of clinical assessment and by COL using a 5-point scale (from 0 = <1 units = no erythema to 4 > 12 units = fiery redness). Concordance and correlation analysis were performed using Cohen's Kappa coefficient and Correlation Coefficient test respectively. At baseline a statistically significant concordance/correlation value between EDDP and COL was observed. At 2 weeks, the statistical concordance/correlation value between instrumentals were both increased, along with a slight significant concordance between clinical assessment and erythema-directed digital photography. At 4, 6 and 8 weeks, a statistically significant increase of concordance/correlation value among all the considered parameters from baseline was found. The results of our study showed that at baseline and during the early treatment stage both EDDP and COL were able to appreciate more accurately the erythema grade compared to clinical observation supporting the use of non-invasive techniques for a more objective evaluation of erythema in rosacea.

Diet and acne: review of the evidence from 2009 to 2020.

BACKGROUND: Dietary habits may play a non-negligible role in the development, duration, and severity of acne, as shown in past critical review articles on such association. METHODS: The aim of this systematic review is to supplement data available on scientific literature spanning the last 10 years by inserting the keywords "acne" or "acne vulgaris" and "diet", "nutrition", "food", "chocolate", "dairy", "whey protein", "fatty acid", or "drink" in the timeframe "January 2009-April 2020" within the PubMed database. RESULTS: Fifty-three reviewed articles met eligibility criteria. They included 11 interventional clinical trials (seven randomized controlled trials and four uncontrolled open label studies) and 42 observational studies (17 case-control and 22 cross-sectional studies, and three descriptive studies). CONCLUSIONS: This review reinforces the notion of a rapidly growing exponential trend of interest in this subject by the scientific community. Acne-promoting factors include high GI/GL food, dairy products, fat food, and chocolate, whereas acne-protective factors include fatty acids, fruit, and vegetable intake. The role played by specific dietary components pertaining to different foods, as done for milk (full-fat/whole, reduced-fat, low-fat/skim milk), dairy products (milk cream, ice cream, yogurt, cheese, etc.), or chocolate (cocoa, dark/milk chocolate), remains an unsolved issue and objective of future research.

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.

Inter-observer evaluation of erythema-directed photography for the assessment of erythema and telangiectasias in rosacea.

BACKGROUND: Persistent centrofacial erythema associated with telangiectasias is one of the most common phenotypes of rosacea in clinical practice, and the assessment of each component is crucial as each of them may require a different approach. The aim of this study was to evaluate the inter-observer reliability of standard photography vs erythema-directed photography for the assessment of erythema and telangiectasias in rosacea. MATERIALS AND METHODS: One hundred full-face images of 50 rosacea patients (50 standard photographs and 50 erythema-directed digital photographs) were evaluated by 8 independent experienced dermatologists using a 5-item score for erythema and telangiectasias, respectively. Inter-rater reliability, by comparing erythema and telangiectasias scores and calculating the percentage of agreement between evaluators, was assessed and the strength of agreement using the Cohen's Kappa values (95% CI) was calculated. RESULTS: Poor and fair strength of agreement for erythema and telangiectasias using standard photography vs moderate and good strength of agreement using erythema-directed digital photography was found. CONCLUSION: Erythema-directed digital photography may provide a better strength of agreement and higher reliability among independent observers compared to standard photography in the assessment of erythema and telangiectasias in rosacea, thus suggesting new horizons for digital appraisal of skin diseases.