A Randomized, Double-Blind, Placebo-Controlled, Multicentric Study to Evaluate the Efficacy and the Tolerability of a Class II Medical Device in the Treatment of Mild and Moderate Acne.

INTRODUCTION: Several options are available to treat acne lesions, including topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, isotretinoin, and procedural therapies, such as light and laser therapies, although these cause side effects. This study aimed to establish the efficacy and tolerability of a class IIa medical device containing lactic acid, azelaic acid/polyglyceryl-3 copolymer, azelamidopropyl dimethyl amine, and bifida ferment lysate for the treatment of mild and moderate acne lesions. METHODS: A randomized, double-blind, placebo-controlled, multicentric study was carried out in which 60 persons of both genders aged ≥ 16 years affected by mild or moderate acne were enrolled. Each person used the product twice daily for 2 months. The clinical score (classified as absent, mild, moderate, and severe) of lesions such as blackheads, whiteheads, papules and pustules, erythema, desquamation, sebum secretion, and porphyrins production by a wood lamp was evaluated on the basis of a dermatologist's visual assessment at baseline (t0) and after 2 months of treatment (t1), and the results were compared between groups. Digital photographic images were also taken. RESULTS: Sixty subjects concluded the trial. It was observed that subjects treated with the medical device (group I) showed overall improvement in the analyzed acne lesions compared with placebo (group II) after 2 months of treatment. The efficacy of the treatment was also expressed as partial and total clearance. The medical device produced higher percentages of both partial and total clearance in all analyzed parameters, compared with the placebo group. The study was safe and well tolerated. CONCLUSIONS: It was observed that the participants showed an overall improvement of the analyzed lesions in comparison with the placebo group, without adverse events during the trial. Hence, the medical device was found to be safe and effective in the treatment of mild or moderate acne.

Hair Aging and Hair Disorders in Elderly Patients.

Hair loss in elderly patients is a common complaint. It can be related to different conditions that affect patients' quality of life and represents a challenge for dermatologists. It affects both men and women during the aging process with an estimated percentage of balding after 65 years of age of 53% and 37%, respectively. Androgenetic alopecia, frontal fibrosing alopecia, senile alopecia, and erosive pustular dermatosis of the scalp are the hair diseases most frequently described in this age group. The objective of this review is to summarize the current knowledge about alopecia affecting elderly patients, differentiating between chronological hair aging signs and pathological changes, to help clinicians, offer an adequate management of these disorders to their patients.

An open-label, investigator-initiated, single-center, prospective, pilot clinical study to evaluate the efficacy of a skin whitening serum applied twice daily combined with a spot-preventing SPF50+ sunscreen in healthy female subjects with melasma hyperpigmentation.

BACKGROUND: Melasma is a common skin disorder characterized by alterations in normal skin pigmentation. The objective was to evaluate the efficacy and safety of a skin whitening serum containing niacinamide, hydroxyphenoxy propionic acid, dipotassium glycyrrhizate, glycolic acid, and 4-n-butylresorcinol applied twice daily combined with a spot-preventing SPF50+ sunscreen for treatment of melasma. METHODS: Twelve healthy Caucasian women with melasma (Fitzpatrick skin types II-IV) were enrolled in this pilot clinical study. Efficacy evaluations were performed at baseline and weeks 4, 8, and 12 of treatment and included clinical and instrumental assessments. RESULTS: All endpoints for melasma hyperpigmentation showed a statistically significant improvement from baseline to the end of the study. There was only one dropout. No signs of irritation or discomfort were observed at baseline, w4, w8, or w12. An overall improvement in melasma was observed both clinically and on reflectance confocal microscopy (RCM). CONCLUSION: This topical skin whitening serum had favorable outcomes for the treatment of melasma hyperpigmentation in adult women, as demonstrated on investigator and instrumental assessments. The results of this pilot study need to be confirmed in randomized, controlled studies with a larger sample size.

Repigmentation of White Forelock in a Familial Case of Piebaldism Reported via Teledermatology in the COVID-19 Era.

Piebaldism is a rare autosomal dominant disorder characterized by leucoderma with leucotrichia. We describe a case of white forelock repigmentation in an infant with piebaldism, thanks to a photograph sent by the patient's mother to our dermatology clinic, during COVID-19 pandemic.

Efficacy and Safety of Dupilumab in Clinical Practice: One Year of Experience on 165 Adult Patients from a Tertiary Referral Centre.

We have read with great interest the article by Kreeshan et al., which reported data on effectiveness and laboratory safety of dupilumab. We performed a retrospective study including 165 adult patients affected by moderate-to-severe atopic dermatitis (AD) and treated with dupilumab for at least 52 weeks. A significant improvement in eczema area severity index (EASI) score after 16 and 52 weeks of treatment with dupilumab was observed. The mean EASI score at baseline was 28.84 ± 6.4 and significantly reduced to 10.05 ± 8.00 at 16 weeks (p < 0.001), and to 3.04 ± 4.73 at 52 weeks (p < 0.001), with a mean percentage reduction of 65.15% and 89.45%, respectively. Efficacy of dupilumab was demonstrated by a significant reduction of all the scores (P-NRS, S-NRS and DLQI). Furthermore, no patient discontinued the drug because of inefficacy. Fifty-seven out of 165 (34.54%) patients reported at least one adverse event (AE) during the 52-week treatment. Our study confirms that dupilumab can represent a long-term treatment for moderate-to-severe adult AD, beyond 16 weeks. In our experience, dupilumab demonstrated a favourable safety profile at 52 weeks and only a few patients had to discontinue the treatment because of AEs.

QuantiFERON TB-gold conversion rate among psoriasis patients under biologics: a 9-year retrospective study.

BACKGROUND: Tuberculosis (TB) screening is mandatory for psoriasis biologic treatment. However, evidences regarding TB screening results during biologic treatment are conflicting. OBJECTIVES: The aim of this study is to evaluate the rate of QuantiFERON TB Gold test (QFT) conversion in psoriasis patients during biologics over time. METHODS: A 9-year single center retrospective study was performed in order to evaluate the rate of QFT conversion in patients affected by moderate-to-severe plaque psoriasis under available biological therapies (anti-TNF-α, IL-12/23, IL-17). For each patient, demographic data, age, gender, comorbidities, previous psoriasis therapy, as well as ongoing treatment type were registered. Five-hundred twenty-six patients (61.2% male, with a mean age of 52.6 ± 13.9 years) treated with biologics were enrolled. RESULTS: QFT conversion occurred in 6.5% of patients over a mean treatment duration of 3.2 years. On average, QFT conversion occurred after 34.05 months of treatment. Anti-TNF-α drugs, and among them, adalimumab above all (35.5% of all cases), were the most commonly involved treatment during QFT conversion, followed by anti-IL-12/23 (17.6%) and anti-IL-17 (14.7%). However, differences among biologics class or single biologics (adalimumab, etanercept, infliximab, golimumab, certolizumab, ustekinumab, ixekizumab, secukinumab) did not approach statistical significance. CONCLUSIONS: Annual TB screening is important in psoriasis patients under biologic treatment in order to avoid possible latent TB infection reactivation. Indeed, our data showed that even in a low TB prevalence country like Italy, QFT may convert over time in psoriasis patients under biologics in 6.5% of the cases.

Rowell Syndrome: A Diagnostic Challenge.

BACKGROUND: Rowell syndrome is a rare disease characterized by a combination of lupus erythematosus (LE) and erythema multiforme (EM)-like lesions and a characteristic immunologic pattern, including speckled pattern of antinuclear antibody (ANA), positive anti-Ro/SSA or anti-La/SSB, and positive rheumatoid factor (RF). This disease was first described in 1963, and to date, about 95 cases of EM-like lesions associated with LE have been described in the literature, with the majority of cases being reported in adult female patients. Here, we describe the case of a 17-year-old male patient exhibiting both systemic LE and EM lesions together with ANA and anti-Ro/SSA positivity who was successfully treated with systemic corticosteroids and hydroxychloroquine.

Erythrodermic psoriasis successfully and rapidly treated with brodalumab: Report of two cases.

Erythrodermic psoriasis (EP) is a rare form of the disease clinically characterized by a generalized erythema covering ≥90% of the body surface area (BSA). The management of EP is challenging: no standardized guidelines exist with literature suggesting cyclosporine or infliximab as first-line therapy. However, a recent systematic review showed a positive response in EP patients treated with biologic agents. The most common biologic used for EP up until now has been ustekinumab, whereas infliximab might represent a first-line option in case of complicated EP (acute, severe, or unstable). Up until now, no case of brodalumab (a monoclonal antibody blocking IL-17 receptor) treatment for EP in real-life has ever been described. Here, we report the first two cases of efficacy and safety of brodalumab in real-life cases of EP.

Vitamin D and psoriasis: an update for dermatologists and nutritionists.

Psoriasis is a common chronic immune-mediated inflammatory skin disease, now considered a systemic inflammatory process with several comorbidities. The skin produces vitamin D by the action of ultraviolet light. Vitamin D performs various immunomodulatory, anti-inflammatory, antioxidant and antifibrotic actions. The immunomodulatory effects of vitamin D offer opportunities to improve the treatment of several autoimmune diseases, such as psoriasis. In the literature, several significant associations are reported between low levels of vitamin D and psoriasis. Today, topical vitamin D represents an important therapeutic option due to its action on the proliferation and maturation of keratinocytes. The situation is different regarding the oral intake and integration of vitamin D in psoriasis patients. The use of vitamin D supplementation as an adjunctive treatment option in these patients is still discussed. This work aims to analyze the association between psoriasis and vitamin D levels according to dermatologists and nutritionists.

A new proprietary gel containing glabridin, andrographolide, and apolactoferrin improves the appearance of epidermal melasma in adult women: A 6-month pilot, uncontrolled open-label study.

BACKGROUND: Melasma-a localized chronic acquired hypermelanosis-is common in adult women and it is difficult to treat. AIMS: We designed a pilot, uncontrolled open-label study to evaluate the appearance of epidermal melasma after 6 months of twice-daily application of a nonprescription proprietary gel formulation containing glabridin, andrographolide, and apolactoferrin. PATIENTS/METHODS: A total of 40 Caucasian women with epidermal melasma (Fitzpatrick skin types II-VI) were enrolled. The study endpoints included standardized clinical photography, determination of Melasma Area and Severity Index (MASI) scores, spectrocolorimeter X-Rite analysis, in vivo reflectance confocal microscopy (RCM), and self-assessment of cosmetic acceptability. RESULTS: All endpoints showed a statistically significant improvement of epidermal melasma from baseline to the end of the study. There were no dropouts and cosmetic acceptability was rated as excellent by all of the study patients. The only observed adverse event was a mild, transient xerosis (n = 3). CONCLUSIONS: Favorable outcomes, as demonstrated by investigator and instrumental assessments, were demonstrated using a proprietary gel for the treatment of epidermal melasma in adult women. Our results need to be confirmed in independent placebo-controlled studies.