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.

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.

Clinical evidences of urea at medium concentration.

Urea-based topical compounds at medium concentrations (15%-30%) represent useful dermatological agents for their humectant and keratolytic effects by enhancing stratum corneum hydration and by loosening epidermal keratin, respectively. The aim of this paper is to review the clinical evidences of the use of 15%-30% urea as single topical agent. Although limited evidence supports the use of these concentrations of urea in skin disorders characterised by xerosis and hyperkeratosis, in clinical practice they are largely used especially in xerosis of limited skin areas, in which the side effects are tolerable, or hyperkeratosis involving large or more sensitive (eg, face, genital region, etc) areas, in which higher concentration may be irritant. In addition, urea at medium concentrations is used in combination with other substances including topical antifungals as penetration enhancer.

Localized acquired lymphangiectasias after breast surgery: Enhanced non-invasive diagnosis using dermoscopy and reflectance confocal microscopy.

BACKGROUND: Acquired lymphangiectasias represent cystic dilatations of the cutaneous lymphatic vessels resulting from damage and/or obstruction of previously normal lymphatics, usually secondary to surgery, radiotherapy, and/or infections. MATERIALS AND METHODS: The clinical, dermoscopic, and confocal microscopy features of three cases of acquired lymphangiectasias occurring after breast surgery are described along with histopathological correlations. RESULTS: Polarized dermoscopy revealed in all lesions the presence of well-circumscribed, white-yellowish lacunae surrounded by pale septa. In addition, some lesions showed scattered reddish areas and red lacunae. Confocal microscopy showed in the upper dermis numerous, roundish dark cavities separated by thin septa. These features corresponded histopathologically to saccular dilations and ectatic lymphatic vessels lined by a single layer of endothelial cells in the papillary/reticular dermis. CONCLUSION: The use of non-invasive diagnostic techniques may be addressed to an enhanced non-invasive diagnosis of acquired lymphangiectasias by showing peculiar features, thus avoiding the need for skin biopsy.

Effectiveness of a new cosmetic treatment for melasma.

BACKGROUND: Melasma treatment is difficult due to extended treatment periods, suboptimal adherence, inconsistent results, and frequent relapses. Kojic acid has been shown to be effective in reducing melasma severity and is now increasingly used in cosmetic treatments. AIMS: The purpose of the present study was to evaluate the effectiveness of a new cosmetic treatment for melasma at 45 and 90 days. METHODS: Multicenter prospective study across 20 dermatology clinics/ambulatories. One hundred patients with mild-to-moderate melasma were evaluated. The primary endpoints were changes in mean modified melasma area and severity index (mMASI) score and patient-reported satisfaction at 45 and 90 days. RESULTS: The mean age of patients was 45.19 ± 11.5 years. Most patients were female and Caucasian. Patients presented mixed (65%), epidermal (26%), and dermal (4%) types of melasma. Triggering factors were hormonal contraception (33%), pregnancy (31%), and pharmacological treatment (11%); mean disease duration was 6.7 ± 6.8 years. Overall, a statistically significant decrease in mean mMASI scores was seen at 45 (2.19 ± 0.182 vs 3.29 ± 0.267, P < .0001) and 90 days (1.27 ± 0.128 vs 3.29 ± 0.267, P < .00001). The highest reduction in mMASI scores was observed in patients with dermal melasma. IGA scores showed a statistically significant improvement in pigmentation at 90 days (P < .00001). CONCLUSION: The novel cosmetic treatment was associated with the improvement of melasma, as assessed by mMASI.

Licochalcone A in Combination with Salicylic Acid as Fluid Based and Hydroxy-Complex 10% Cream for the Treatment of Mild Acne: A Multicenter Prospective Trial.

PURPOSE: Topical cosmetic agents if correctly prescribed and used may improve outcomes in acne therapy. The aim of this study was to assess the efficacy and tolerability of a new daily cosmetic regimen in the treatment of mild facial acne. PATIENTS AND METHODS: A multicenter, prospective, observational, clinical study was conducted on 91 adult patients with mild acne. Subjects were instructed to apply a fluid containing Licochalcone A/Salicylic acid/L-Carnitine in the morning and a cream with Licochalcone A/Hydroxy-Complex 10% at bedtime for 8 weeks. The efficacy was clinically evaluated by Global Acne Grading System (GAGS) score and by comedones/papules lesions count and by instrumental assessment (SebutapeTMand Reveal Photo Imager/VISIA-CR™ imaging) at baseline, at 4 and 8 weeks. RESULTS: At 4 weeks a statistically significant reduction from baseline of GAGSwas observed. In addition, the mean total count of comedones and papules was significantly reduced by 41% and 45%, respectively, from baseline along with a significant reduction of mean sebum of 47%. At 8 weeks, a further statistically significant reduction from baseline of GAGS, total count of comedones and papules (64% and 71%, respectively), along with an additional sebum reduction of about 52% was also recorded. CONCLUSION: Our results suggest that the daily regimen based on Licochalcone A with Salicylic acid/L-Carnitine as fluid or with Hydroxy-Complex 10% as cream represent an interesting cosmetic approach for treating mild acne.

A novel cosmetic antifungal/anti-inflammatory topical gel for the treatment of mild to moderate seborrheic dermatitis of the face: an open-label trial utilizing clinical evaluation and erythema-directed digital photography.

BACKGROUND: Topical cosmetic agents may play a role in the management of facial seborrheic dermatitis by reducing inflammation and scale production. Advanced digital photography, equipped with technology able to provide a detailed evaluation of red skin components corresponding to vascular flare (erythema-directed digital photography), is a useful tool for evaluation of erythema in patients affected by inflammatory dermatoses. The aim of this study was to assess the efficacy and safety of a new cosmetic topical gel containing piroctone olamine, lactoferrin, glycero-phospho-inositol, and Aloe vera for the treatment of facial seborrheic dermatitis by clinical and advanced digital photography evaluation. METHODS: An open-label, prospective, clinical trial was conducted on 25 patients with mild to moderate facial seborrheic dermatitis. Subjects were instructed to apply the gel twice daily for 45 days. The clinical efficacy was evaluated by measuring at baseline, at day 15 and 45 the degree of desquamation (by clinical examination) and erythema (by digital photography technology via VISIA-CR™ system equipped with RBX™), using a 5-point severity scale, and pruritus (by subject-completed Visual Analogue Scale; scale from 0 to 100 mm). Finally, at baseline and at the end of the study, IGA (Investigator Global Assessment) was performed using a 5-point severity scale (from 0 = worsening to 4 = excellent response). RESULTS: At the end of treatment, a significant reduction (P<0.001) of all considered parameters was observed. Moreover, an excellent response (>80% improvement) was recorded in 47.9% of patients, with no case of worsening. No signs of local intolerance were documented. CONCLUSIONS: The tested cosmetic topical gel was effective in treating mild to moderate seborrheic dermatitis of the face. Erythema-directed digital photography may represent a noteworthy tool for the therapeutic monitoring of facial seborrheic dermatitis and an important adjunct aid in the dermatologic clinical practice.

Confocal microscopy and imaging profilometry: A new tool aimed to evaluate aesthetic procedures.

According to the American Academy of Aesthetic Plastic Surgeons, more than 11 million cosmetic surgical and nonsurgical procedures were performed by board-certified plastic surgeons, dermatologists and otolaryngologists in the United States, totaling more than 12 billion dollars. We performed a retrospective observational multi-centric study on patients treated with a non-animal origin cross-linked hyaluronic acid with different molecular weights for nasolabial folds, evaluating through a new imaging system, profilometric techniques with the confocal microscopy, the durability, the efficacy and the safety of this product. From 25 patients, 150 silicone casts were obtained: 75 casts of the right nasolabial fold and 75 casts of the left nasolabial fold. Roughness arithmetical average of the right fold at T2 decreased by 50% versus T0 and by 40% compared to T1; at T2, it decreased by the 45% versus T0 and by 35% compared to T1. No side effects were reported. Results proved that the analysis of the skin microreliefs through confocal microscopy is a new imaging system that allows to evaluate with precision and safety the results of aesthetic treatments such as fillers objectively.

Role of cleansers in the management of acne: Results of an Italian survey in 786 patients.

BACKGROUND: Modern therapy of acne is based also on moisturizers, cleansers and sunscreens. However, a few studies have been published on cleansers, and never in Italy. OBJECTIVE: We decided to carry out an epidemiological study on the knowledge, beliefs and perceptions of acne patients regarding cleansers. METHODS: The survey has been carried out in Italy in 2013-2014. A group of patients with acne completed a questionnaire which included 10 questions. RESULTS: One hundred and eighteen dermatologists and 786 evaluable acne patients attended the survey. Approximately 70% of patients use a specific anti-acne cleanser. This cleanser is suggested in 57% of cases by a dermatologist. The patients buy this cleanser at the pharmacy (77% of cases). More than 62% of patients are satisfied about this cleanser. More than 66% of patients use the cleanser twice daily. The length of washing is less than one minute in 48% of patients. More than 66% of patients believe that the cleanser has a therapeutical role. CONCLUSION: The results of this survey cannot be compared with other studies because of the lack of similar studies about this topic. These results suggest that a sample of Italian acne patients consider cleansers as an important adjuvant treatment in acne.

Evaluation of a Topical Anti-inflammatory/Antifungal Combination Cream in Mild-to-moderate Facial Seborrheic Dermatitis: An Intra-subject Controlled Trial Examining Treated vs. Untreated Skin Utilizing Clinical Features and Erythema-directed Digital Photography.

OBJECTIVE: To evaluate if nonprescription topical agents may provide positive outcomes in the management of mild-to-moderate facial seborrheic dermatitis by reducing inflammation and scale production through clinical evaluation and erythema-directed digital photography. SETTING: Open-label, prospective, not-blinded, intra-patient, controlled, clinical trial (target area). PARTICIPANTS: Twenty adult subjects affected by mild-to-moderate facial seborrheic dermatitis were enrolled and instructed to apply the study cream two times daily, initially on a selected target area only for seven days. If the subject developed visible improvement, it was advised to extend the application to all facial affected area for 21 additional days. MEASUREMENT: Efficacy was evaluated by measuring the grade of erythema (by clinical examination and by erythema-directed digital photography), desquamation (by clinical examination), and pruritus (by subject-completed visual analog scale). Additionally, at the end of the protocol, a Physician Global Assessment was carried out. RESULTS: Eighteen subjects completed the study, whereas two subjects were lost to follow-up for nonadherence and personal reasons, respectively. Day 7 data from target areas showed a significant reduction in erythema. At the end of study, a significant improvement was recorded for erythema, desquamation, and pruritus compared to baseline. Physician Global Assessment showed improvement in 89 percent of patients, with a complete response in 56 percent of cases. CONCLUSION: These preliminary results indicate that the study cream may be a viable nonprescription therapeutic option for patients affected by facial seborrheic dermatitis able to determine early and significant improvement. This study also emphasizes the advantages of using an erythema-directed digital photography system for assisting in a simple, more accurate erythema severity grading and therapeutic monitoring in patients affected by seborrheic dermatitis.

Mesotherapy with an Intradermal Hyaluronic Acid Formulation for Skin Rejuvenation: An Intrapatient, Placebo-Controlled, Long-Term Trial Using High-Frequency Ultrasound.

Mesotherapy with hyaluronic acid (HA) is a treatment approach currently used for skin rejuvenation. High-frequency ultrasound (20-100 MHz) is a non-invasive technique that has been used to evaluate age-related dermal changes. The presence and the degree of a typical subepidermal low-echogenic band (SLEB) are photoaging related: the lower the SLEB echogenicity, the higher the photoaging. The aim of this trial was to evaluate, through ultrasound imaging, the long-term effects of microinjections of HA on SLEB echogenicity. Twenty-two women with clinical and ultrasound signs of moderate photoaging were enrolled in the study. Treatment consisted of multiple microinjections of HA salts of biotechnological origin on the dorsum of one hand, once weekly for 4 weeks and, successively, once monthly for 4 months (group A) or 9 months (group B). The dorsum of the other hand of each subject was injected with saline solution and used as a control. In all subjects, high-frequency ultrasound (22 MHz) was performed to evaluate SLEB echogenicity changes during treatment. Eighteen out of 22 patients completed the study. At the end of 4 weeks, an ultrasound increase of dermal echogenicity was observed in 13 subjects (seven of group A and six of group B), which we considered as "responders". In these patients, the Student's t-test showed a significant increase from baseline of SLEB pixel numbers of +24 % (P < 0.01) versus +6 % with placebo. In the same subjects, after an additional 4 months of monthly injections, the mean increase was +18 % (P < 0.05) versus +4 % with placebo. In patients from group B that completed 10 months of treatment, the increase from baseline of SLEB pixel numbers was +18 % (P < 0.05) versus 0 % with placebo. Our study suggests that mesotherapy with HA may effectively improve skin aging and photoaging, as supported by quantifiable ultrasound data showing significant changes in SLEB density over time.

Clinical and ultrasonographic correlation of acne scars.

BACKGROUND: Consensus concerning nomenclature and classification of acne scars is lacking. Classification based solely on clinical examination represents an unmet need that could be improved with the use of objective, reproducible assessments. OBJECTIVE: To assess clinical and ultrasound morphologic features in 41 patients with scars resulting from moderate to severe acne and to determine whether correlation exists. MATERIALS AND METHODS: Eighty-one lesions clinically identified as boxcar, ice pick, rolling, hypertrophic, or keloidal were evaluated using high-frequency ultrasound (22 MHz). RESULTS: Ultrasound results generally correlated with clinical appearance. Eight scars clinically classified as ice pick showed a typical boxcar morphology upon ultrasound examination. Ultrasound showed that ice pick and boxcar scars were the deepest, with 95.8% between 0.2 and 0.5 mm. CONCLUSIONS: High-frequency ultrasound is a noninvasive technique that is useful in the evaluation and correct classification of acne scars. It represents an important adjunct to clinical examination, because it provides reliable objective and reproducible information useful to the selection of the best treatment option specifically customized to each individual patient's needs.

The use of videodermatoscopy to monitor treatment of scabies and pediculosis.

A great pitfall for scabies and pediculosis therapeutic studies to date is that primary and secondary study outcomes are indirectly assessed (presence or absence of live parasites, including eggs, determined by gross clinical inspection) and data time points are non-standardized (highly variable) relative to the time of therapeutic application. Videodermatoscopy (VD) is a non-invasive technique that allows a rapid and magnified in vivo observation of the skin up to × 1000 with the visualization of morphologic features invisible to the naked eye. Utilization of VD in establishing highly definitive and precise quantitative data products used in the treatment of scabies and pediculosis provides enormous advantages in the quest to establish reproducible quantitative methodology for efficacy studies in these parasitoses. VD enhances the monitoring of clinical response to treatment in scabies and pediculosis and allows determination of the optimal timing of drug application both in vivo and ex vivo. This may be particularly important in minimizing risk of overtreatment, reducing the potential for side effects, and enhancing patient compliance.

Canal versus cysts of the penile median raphe: advancing diagnostic methods using videodermatoscopy.

Median raphe cysts represent defects of embryologic development of the male genitalia during fetal life. A clinical variant is represented by raphe canals, which consist of elongated tracts located in the same areas. Videodermatoscopy is a noninvasive technique that may be helpful in the differentiation between cysts and canals of the median raphe of the penis, thus helping to establish the most appropriate therapeutic approach.

Mesotherapy for skin rejuvenation: assessment of the subepidermal low-echogenic band by ultrasound evaluation with cross-sectional B-mode scanning.

Skin-targeted ultrasound is a noninvasive technique that has been extensively used to evaluate age-related dermal changes, and the presence of a subepidermal low-echogenic band (SLEB) has been related to chronic UVR exposure in several studies. Since SLEB echogenicity is photoage-related, the aim of this study was to evaluate, through ultrasound imaging, the effects on skin photoaging of mesotherapy, a treatment approach currently used in cosmetic dermatology for skin rejuvenation. Twenty women (mean age: 46.7 range 40-60 years) with physical signs of moderate photoaging on the dorsum of the hands were enrolled and treated with multiple microinjections of hyaluronic acid (HA) salts of biotechnological origin (1.000 Kd) every week for 4 weeks. In all subjects, ultrasound evaluation was performed at each visit and 1 week after the last treatment to evaluate SLEB echogenicity changes during treatment. At the end of study, a statistically significant (p < 0.001) increase of SLEB echogenicity (with a mean increase of pixel numbers equal to 31.3%) was observed in 15 of 19 subjects who completed the study. Our preliminary study suggests that mesotherapy with HA may be an effective treatment for skin photoaging, as confirmed by ultrasound. Follow-up investigations on larger series of patients are necessary to further evaluate the safety, effectiveness, and duration of effect of this possible therapeutic approach to skin photoaging.

Corrective camouflage in pediatric dermatology.

Many dermatologic diseases, including vitiligo and other pigmentary disorders, vascular malformations, acne, and disfiguring scars from surgery or trauma, can be distressing to pediatric patients and can cause psychological alterations such as depression, loss of self-esteem, deterioration of quality of life, emotional distress, and, in some cases, body dysmorphic disorder. Corrective camouflage can help cover cutaneous unaesthetic disorders using a variety of water-resistant and light to very opaque products that provide effective and natural coverage. These products also can serve as concealers during medical treatment or after surgical procedures before healing is complete. Between May 2001 and July 2003. corrective camouflage was used on 15 children and adolescents (age range, 7-16 years; mean age, 14 years). The majority of patients were girls. Six patients had acne vulgaris; 4 had vitiligo; 2 had Becker nevus; and 1 each had striae distensae, allergic contact dermatitis. and postsurgical scarring. Parents of all patients were satisfied with the cosmetic cover results. We consider corrective makeup to be a well-received and valid adjunctive therapy for use during traditional long-term treatment and as a therapeutic alternative in patients in whom conventional therapy is ineffective.

Infantile psoriasis.

Psoriasis is a common inherited papulosquamous dermatosis that may be a diagnostic dilemma, particularly in infants and children. The treatment of children with psoriasis should be handled with caution and tailored according to the child's age, as well as to the extent, distribution, and type of psoriasis.

Management of cutaneous warts: an evidence-based approach.

Cutaneous warts are benign epidermal proliferations caused by human papillomavirus infection. Treatment aims to cure the patient's physical and psychological discomfort, and to prevent the spread of infection by contact with other body areas or with other individuals. Among the available medical and destructive therapeutic options for cutaneous warts, none is uniformly effective or virucidal. Moreover, in most cases the safety and efficacy of these treatment options has not been assessed in randomized controlled trials, so that the reproducibility of many of the listed treatments is difficult to evaluate and a possible placebo effect cannot be ruled out. This article provides indications for the management of patients with cutaneous warts through an evidence-based approach, considering a first-, second-, and third-line therapy for each clinical form. The first line includes medical treatments useful to cure single, or few, and/or small common warts of short duration (<1 year). If these treatments have failed or are contraindicated, cryotherapy may be considered as second-line therapy. For recurrent or difficult-to-treat lesions, a third-line of therapy includes a variety of alternative therapeutic options that are in clinical use but are not necessarily approved by the US FDA, and their use may be further limited by adverse effects.