Topical applications of heterologous platelet rich plasma (PRP) for refractory gingival lesions in autoimmune blistering diseases.

BACKGROUND: Recalcitrant gingival erosions, blisters and desquamative gingivitis are common features in oral autoimmune blistering diseases (AIBD). First line treatments include high-dosage corticosteroids and other immunosuppressive drugs, with several side effects and elevated number of recurrences. Autologous platelet-rich plasma (PRP) has been recently introduced as an alternative treatment and its use seems to be promising and safe. METHODS: In this study we describe the use of topical application of heterologous PRP in nine patients affected by mucous membrane pemphigoid, with gingival lesions refractory to previous treatments. Topical applications of PRP were performed once a week for 2 months and the endpoint for clinical evaluation was set 3 months after the last session. Oral disease severity score (ODSS) and VAS scores for pain measurement were recorded before and after treatment. RESULTS: The procedure was painless, well accepted, and free from adverse reactions. All patients (100%) reported a reduction in VAS whereas reduction in ODSS was observed in 89% of patients. CONCLUSIONS: Within the limits of the study, topical heterologous PRP is a safe and promising procedure to be studied in future controlled randomized trials as adjuvant treatment for refractory gingival lesions in patients with AIBDs.

Efficacy and safety of N-acetyl-GED-0507-34-LEVO gel in patients with moderate-to severe facial acne vulgaris: a phase IIb randomized double-blind, vehicle-controlled trial.

BACKGROUND: Preliminary in vitro and in vivo studies have supported the efficacy of the peroxisome proliferator-activated receptor-γ (PPARγ) modulator N-acetyl-GED-0507-34-LEVO (NAC-GED) for the treatment of acne-inducing sebocyte differentiation, improving sebum composition and controlling the inflammatory process. OBJECTIVES: To evaluate the efficacy and safety of NAC-GED (5% and 2%) in patients with moderate-to-severe facial acne vulgaris. METHODS: This double-blind phase II randomized controlled clinical trial was conducted at 36 sites in Germany, Italy and Poland. Patients aged 12-30 years with facial acne, an Investigator Global Assessment (IGA) score of 3-4, and an inflammatory and noninflammatory lesion count of 20-100 were randomized to topical application of the study drug (2% or 5%) or placebo (vehicle), once daily for 12 weeks. The co-primary efficacy endpoints were percentage change from baseline in total lesion count (TLC) and IGA success at week 12; the safety endpoints were adverse events (AEs) and serious AEs. This study was registered with EudraCT (2018-003307-19). RESULTS: Between Q1 in 2019 and Q1 in 2020 450 patients [n = 418 (92·9%) IGA 3; n = 32 (7·1%) IGA 4] were randomly assigned to NAC-GED 5% (n = 150), NAC-GED 2% (n = 150) or vehicle (n = 150). The percentage change in TLC reduction was statistically significantly higher in both the NAC-GED 5% [-57·1%, 95% confidence interval (CI) -60·8 to -53·4; P < 0·001] and NAC-GED 2% (-44·7%, 95% CI -49·1 to -40·1; P < 0·001) groups compared with vehicle (-33·9%, 95% CI -37·6 to -30·2). A higher proportion of patients treated with NAC-GED 5% experienced IGA success (45%, 95% CI 38-53) vs. the vehicle group (24%, 95% CI 18-31; P < 0·001). The IGA success rate was 33% in the NAC-GED 2% group (P = not significant vs. vehicle). The percentage of patients who had one or more AEs was 19%, 16% and 19% in the NAC-GED 5%, NAC-GED 2% and vehicle groups, respectively. CONCLUSIONS: The topical application of NAC-GED 5% reduced TLC, increased the IGA success rate and was safe for use in patients with acne vulgaris. Thus, NAC-GED, a new PPARγ modulator, showed an effective clinical response. What is already known about this topic? Acne vulgaris, one of the most common dermatological diseases, affects more than 85% of adolescents. There is a medical need for innovative and safe treatment of acne vulgaris. The peroxisome proliferator-activated receptor-γ (PPARγ) is involved in lipid metabolism and specifically in cell differentiation, sebum production and the inflammatory reaction. What does this study add? N-acetyl-GED-0507-34-LEVO (NAC-GED 5%), a PPARγ modulator, significantly improves acne manifestations in patients with moderate-to-severe acne and is safe and well tolerated. The results suggest that the PPARγ receptor is a novel therapeutic target for acne. The results provide a basis for a large phase III trial to assess the effectiveness and safety profile of NAC-GED in combating a disease that afflicts 80-90% of adolescents.

Skin Toxicities with Cyclin-Dependent Kinase 4/6 Inhibitors in Breast Cancer: Signals from Disproportionality Analysis of the FDA Adverse Event Reporting System.

BACKGROUND: Cyclin-dependent kinase (CDK)-4/6 inhibitors have been associated with dermatologic reactions, especially alopecia, in pivotal trials. OBJECTIVE: We aimed to comprehensively describe skin toxicities with CDK4/6 inhibitors reported in the real world through the US FDA Adverse Event Reporting System (FAERS). METHODS: Cutaneous adverse events (AEs) were characterized in terms of spectrum and clinical features, including seriousness (with fatality proportion), latency, and discontinuation. Disproportionality analyses were performed through the reporting odds ratio (ROR) and 95% confidence interval (CI) by comparing CDK4/6 inhibitors with other anticancer drugs used in breast cancer. RESULTS: As of December 2020, a total of 7986 cutaneous events were reported with CDK4/6 inhibitors (15% of total AEs with CDK4/6 inhibitors), mainly by consumers (39.6%), with 43.5% classified as serious and 25% requiring discontinuation. In 49% of the cases, five or more noncutaneous events were co-reported. The most frequently reported cutaneous events were alopecia (N = 3528), rash (N = 1493), and pruritus (N = 1211): rashes were recorded in the first month (median onset 28 days), whereas alopecia and nail alterations were recorded after a median of 67 and 112 days, respectively. Several cutaneous AEs were associated with increased reporting, including vitiligo (N = 6; ROR 8.88; 95% CI 2.95-22.46) and bullous dermatitis with ribociclib (N = 7; ROR 2.90; 95% CI 1.13-6.27); erythema multiforme with abemaciclib (N = 9; ROR 5.80; 95% CI 2.57-11.48); onychoclasis (N = 142, ROR 2.27; 95% CI 1.83-2.79) and trichorrhexis (N = 22; ROR 3.27; 95% CI 1.78-5.93) with palbociclib. CONCLUSIONS: Although causality cannot be demonstrated, a diverse reporting pattern of cutaneous AEs emerged from FAERS, including dermal/epidermal conditions, hair/nail disorders, and serious bullous conditions, with variable onsets and a remarkable proportion of discontinuations. The potential differential reporting among CDK4/6 inhibitors deserves further investigation.

A peristomal plaque of sudden occurrence.

Koebner phenomenon regards the formation of a psoriatic lesion after a trauma, including tattoo, insect bite or other injuries. Although this manifestation is not specific for psoriasis, physicians should be aware because early recognition may be helpful in making the diagnosis when present.

Contact dermatitis due to masks and respirators during COVID-19 pandemic: What we should know and what we should do.

Given the current lack of a therapeutic vaccine for coronavirus disease 2019 (COVID-19), preventive measures including mask wearing are crucial in slowing the transmission of cases. However, prolonged wearing of protective respirators, medical and fabric masks can easily generate excessive sweating, moisture and friction. Closed and warm environments heighten the skin's permeability and sensitivity to physical or chemical irritants, leading to chronic cumulative irritant contact dermatitis or, rarely, even allergic contact dermatitis. Although not representing a life-threatening condition, contact dermatitis can have a significant impact on emergency management, as it is potentially able to reduce work performance and create emotional discomfort due to the involvement of evident body areas. To minimize the skin breakdown, adherence to standards on wearing protective and safe equipments and avoidance of overprotection should be performed. At the same time, some measures of skin care are recommended. Here, we offer some tips on how to prevent and manage contact dermatitis due to masks not only in health care workers, but also in the general population during this COVID-19 outbreak.