Efficacy and Tolerability of Hybrid Complexes of High- and Low-Molecular-Weight Hyaluronan Intradermal Injections for the Treatment of Skin Roughness and Laxity of the Neck.

This study aimed to evaluate the efficacy of a well-characterized formulation of hyaluronic acid (HA), Profhilo®, in the treatment of roughness and laxity of the neck skin. The study was performed on 25 subjects ranging in age from 40 to 65 years. Two injections of the studied product at 30-day intervals were performed, with evaluations conducted 1 and 4 months after the first injection. The efficacy was determined by clinical and multilevel instrumental evaluations. In addition, at the end of the study, the subjects completed a questionnaire related to the efficacy and tolerability of the product. The studied product was shown to induce a clear and statistically significant improvement in the skin of the neck in all the subjects, with concordant results between the clinical, instrumental, and subjects' evaluations. The positive effects, present after the first injection, were further increased in the second and last evaluation. Notably, the product was reported to have a very high tolerability by both clinicians and subjects. In conclusion, two injections of the studied product safely induced skin amelioration in subjects with mild to moderate neck skin roughness and laxity.

Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot study.

Background and Aims: Hyaluronic acid (HA)-based injections are used worldwide to improve skin defects associated with aging and ultraviolet light/environmental exposure. HA formulations developed according to molecular weight or with additional components, for example, cross-linking reagents, are limited by their low biological activity and concentration limit. NAHYCO™ technology has enabled the production of hybrid cooperative complexes (HCCs) of low and high molecular weight HA. Developed for injection into the fat compartments of the face and previously demonstrating potential benefits for adipose tissue restoration, Profhilo Structura® is a new 2 mL HCC formulation comprising low molecular weight HA (45 mg/mL) and high molecular weight HA (45 mg/mL). To evaluate the efficacy and tolerability of Profhilo Structura® to restore adipose tissue compartments in the lateral cheek fat compartment. Methods: Fifty healthy enrolled subjects received two injections, 1 month apart, and were evaluated 3 months posttreatment. Investigators performed clinical evaluations (Facial Volume Loss Scale [FVLS] and Wrinkle Severity Rating Scale [WSRS]) at different time points. Subjects also completed self-evaluation assessments following treatment. Results: A significant improvement in FVLS and WSRS clinical scores after the first treatment was observed; treatment benefit was maintained 3 months after treatment completion and confirmed by subject self-assessment. Most participants reported an improvement, particularly a marked reduction of wrinkles and increased skin firmness. No serious adverse events were reported, confirming the excellent safety profile of HCC injectable devices. Conclusions: Overall, the study highlighted the efficacy and tolerability of the studied medical device proving its effect on adipose tissue.

Assessment of the antidandruff activity of a new shampoo: a randomized, double-blind, controlled study by clinical and instrumental evaluations.

The aim of this randomized, double-blind, controlled study was to evaluate the antidandruff activity exerted by a new shampoo on patients affected by dandruff and/or mild seborrheic dermatitis by means of both D-squame technique coupled with image analysis and clinical assessments. Thirty-four patients were enrolled and 1:1 randomly assigned to either a test shampoo or a comparative shampoo group. Treatment schedule was twice a week for 4 weeks. The D-squame technique was shown to be able to objectively record variations in scalp desquamation both between test and comparative groups and within the same group over time. The results obtained with this instrumental approach showed a statistically significant reduction by 52% vs baseline after 2 weeks of treatment. There was an even greater reduction after 4 weeks (-66%). This reduction was statistically significant compared with the comparative group at the same time points. The analysis of all the other parameters (except Wood's lamp) confirmed the superiority of the test vs the comparative shampoo. The test shampoo proved to be safe, well tolerated, and accepted by the patients for cosmetic acceptability and efficacy. The study confirmed the antidandruff efficacy of the test shampoo and its superiority vs the comparative shampoo.

The Role of a Novel Generation of Emollients, 'Emollients Plus', in Atopic Dermatitis.

Emollients are the mainstay maintenance treatment for atopic dermatitis (AD). A novel generation of emollients, 'emollients plus', containing active, non-medicated substances, has softened the distinction between emollients and topical drugs. A literature search for selected key words was performed using PubMed. Additional papers were identified based on author expertise. Whilst the inclusion of five components of an ideal emollient has been proposed, no such consensus exists for emollients plus and they can vary markedly in their composition and modes of action for AD treatment. This could have a profound effect on their clinical efficacy. The efficacy of emollients plus in restoring and maintaining skin barrier function has been demonstrated on multiple levels, with evidence reported for their effects on the physical and biochemical, microbial, immunological, and neurosensory barriers. When selecting an appropriate AD treatment approach, the safety profiles of the available topical therapies must be carefully considered. There are several proposed treatment approaches for AD, including preventive, proactive, intermittent, and synergistic approaches. Emollients plus may be effective not only as maintenance therapy for AD, but also when used synergistically with anti-inflammatory pharmacological therapies.

The Clinical Evidence-Based Paradigm of Topical Anti-Aging Skincare Formulations Enriched with Bio-Active Peptide SA1-III (KP1) as Collagen Modulator: From Bench to Bedside.

A substantial reduction in the amount and quality of collagen leads to age-related deterioration of the elasticity and firmness of the skin. In recent years, multiple compounds have been developed aimed at reversing the molecular features of dermal aging. One such target for aging reversal is collagen degradation or turnover. SA1-III is a decapeptide (Ac-Met-Gly-Lys-Val-Val-Asn-Pro-Thr-Gln-Lys-NH2), also known as KP1, formally derived from the C-terminal portion of serpin A1, an agent known as a physiological inhibitor of neutrophil elastase, and has been the subject of laboratory and clinical studies determining its effects on modulation of collagen turnover as well as the treatment of age-associated changes of the face. This review aims to provide a bio-inspired approach focusing on the latest scientific studies that describe the compound, as well as a comprehensive appraisal of laboratory and clinical tests on skincare formulations enriched with sA1-III.

Evaluation of anti-cellulite efficacy: a topical cosmetic treatment for cellulite blemishes - a multifunctional formulation.

Cellulite is thought to affect 80-90% of postpubertal women, and is considered much of a cosmetic concern by the large majority of them. In this study, the objective was to assess the efficacy of a topical cosmetic product containing various active ingredients of botanical origin on cellulite blemishes on female volunteers affected by fat accumulations, as well as by slight-to-moderate cellulite in the lower limbs. The assessment was performed by means of various objective evaluations, including contact thermography, morphometric measures of thigh circumference, and microcirculation evaluation. The obtained results indicate that the use of synergistic botanical standardized extracts, through the exploitation of different mechanisms of action and acting on different biological targets, provides visible and measurable results in the improvement of cellulite signs and symptoms.

In vitro and in vivo Evaluation on the Safety and Efficacy of a Brand-New Intracutaneous Filler with α1-R-Collagen.

Nowadays, the most advanced skin anti-aging treatments are addressed to restore the extracellular matrix (ECM) homeostasis. ECM is considered the main player not only as physical support of the tegument but also at the biochemical level, thanks to its capacity to exchange nutrients, water, cellular mediators, and growth factors within and between cells. This study aimed to evaluate the in vitro and in vivo efficacy and aesthetic performance of a brand-new intracutaneous filler. The latter is based on novel concepts: besides filling it exerts a homeostatic balance of nutrients able to delay the skin aging process by sustaining physiological rejuvenation of the tissue and in the surrounding injection/implantation area. The brand-new intracutaneous filler was tested for in vitro capacity to stimulate extracellular matrix components production. Therefore, a single session for injection of the product under study was performed by a specialized dermatologist, using the bolus technique on the zygomatic protuberance of 20 healthy female subjects with midface volume loss, caused by aging. Results confirmed the important and long-term volumizing, anti-wrinkle, the hydrating activity of this product after one single injection session. The biological outcomes also support product effectiveness in skin structure restoration.

"Quitting smoking rejuvenates the skin": results of a pilot project on smoking cessation conducted in Milan, Italy.

This study reports the results obtained during the "Quitting Smoking Rejuvenates the Skin" campaign, a pilot project in favor of the fight against nicotine addiction in women promoted by the Municipality of Milan jointly with other organizations. The initiative allowed researchers to evaluate the benefits on the skin obtained by cessation of smoking in a sample of 64 Caucasian women who smoked and who, in the period between February 2007 and November 2007, were followed by a team of dermatologists, psychologists, and nutritionists. During the dermatologic program, clinical and instrumental evaluations were made at the beginning of the study and at 3, 6, and 9 months. The state of skin aging was evaluated visually by giving a clinical score to each sign of skin aging (lines, vascular and pigmentation state, elasticity, brightness, texture of the skin). These signs were then correlated using a particular "spider web" graph called Spiderming, the result of Derming research that allows the monitoring of results obtained over time. Taking into account that a wider area of the graph coincides with more advanced skin aging, the graph of mean values observed in the study patients narrowed as time went by, reaching certain statistically significant values in as little as 6 months of observation. The patients' biological skin age was also calculated so as to better quantify the benefits they obtained by giving up smoking. It was possible to measure the biological age of the skin using noninvasive instrumental measurements of parameters such as skin smoothness, brightness, coloring, and elasticity. A complex mathematic algorithm processed the results obtained for each patient and, on this basis, calculated the biological age of the patient's skin. At the end of the program, an average reduction of about 13 years in the biological age of the patients' skin was found, while, at the beginning of the study, patients had presented with an average biological age of 9 years older than their chronologic age. This pilot project not only demonstrated that quitting smoking improves skin conditions, and above all skin-aging effects, but for the first time it afforded the opportunity to produce data that quantify this benefit.

Evaluation of the Volumizing Performance of a New Volumizer Filler in Volunteers with Age-Related Midfacial Volume Defects.

PURPOSE: The primary aim of this study was to evaluate the performance of the study product, in terms of volumizing activity as well as the duration of the effect, in women with age-related midfacial volume defects. In addition, the study allowed the evaluation of the tolerability of the product by both volunteers and investigators. PATIENTS AND METHODS: Twenty-two female volunteers, aged 42-60 years, participated in this study, which was performed under dermatological control in a single center. After an initial visit at baseline to verify adherence to the protocol criteria, volunteers received an injection of Aliaxin® SV (IBSA Farmaceutici Italia Srl), followed 3-4 weeks later by a second touch-up treatment to treat eventual asymmetries. Four subsequent visits, the last performed 9 months from the first injection, were performed to evaluate clinically and instrumentally the efficacy of the treatment. RESULTS: Clinical and statistically significant improvement in cheek volume was recorded after the first postinjection visit, and the effect was maintained until the end of the study period. A clinically measurable amelioration of wrinkle severity was also observed. By 3D picture recording and subsequent quantitative analysis, it was possible to determine the efficacy in terms of increased facial volume, which was already appreciable at the first visit, was further increased at the second and third visits and was maintained at the fourth and last visits. The injections were very well tolerated by the volunteers, as determined by their self-evaluation questionnaires. CONCLUSION: The results of the study confirm the esthetic performance of the study product on age-related midfacial volume defects. The very strong high-volumizing activity of the study product was not only properly determined by the investigators but also confirmed by self-evaluation by the volunteers. These effects were obtained with no appreciable undesired effects.

Efficacy and tolerability of a biomineral formulation for treatment of onychoschizia: a randomized trial.

Purpose: Onychoschizia causes lamellar splitting of the nail plate. It is a common problem seen by dermatologists therefore, an effective treatment is needed. The aim of this study was to evaluate the efficacy and tolerability of a biomineral formulation (Biomineral Unghie) applied topically, and/or as an oral supplement, in subjects with onychoschizia. Patients and methods: This single center, randomized, parallel-group, open-label study was conducted between March 2017 and June 2017. Fifty non-menopausal females aged 18 years or over with onychoschizia were randomized (1:1:1) into three treatment arms to receive either topical and/or oral biomineral formulation for 3 months. Subjects were randomized using a predefined randomization list. The primary objective was to determine the efficacy of the biomineral formulation. Results: Forty-eight subjects were included in the clinical assessment of nail hardness with 16 subjects in each treatment arm. After 3 months, fingernail hardness improved across the topical, oral and combined treatment arms compared with baseline: 40% (P<0.01 versus untreated hand), 43% and 50% (P<0.05 for both), respectively. Image analysis of the nail was carried out on 33 subjects with longitudinal and/or transversal fingernail grooves. Nail roughness was significantly reduced across all arms after 3 months compared with baseline (topical [n=11], -12%; oral supplement [n=10], -18%; combined topical/oral [n=12], -15%; all P<0.05). Subjects considered fingernail resistance, smoothness, glossiness, growth and general nail condition to be improved across all treatment arms. No adverse events were reported. Conclusion: The biomineral formulation was effective in improving nail condition in subjects with onychoschizia after 3 months.

A randomized single-blind placebo-controlled study of a Visnadine Emulgel formulation on healthy postmenopausal women.

BACKGROUND: There is a growing interest on women' sexual function improvement provided by topical vulvar application of Visnadine, a natural extractive substance with putative vasodilatory properties. Aims of this study were to evaluate: 1) the vasokinetic activity of a Visnadine Emulgel on mucosal genitalia of 15 healthy postmenopausal women clinically and by instrumental non-invasive analysis; 2) the treatment efficacy by volunteers' judgment regarding to subjective comfort, pleasant warmth, lubrication grade, pinching and burning vulvar sensations. METHODS: Fifteen informed healthy female volunteers with menopause were enrolled in the study, with a single blind controlled study versus placebo corresponding to one single application of the emulgel product (active or placebo) on external genitalia. RESULTS: Visnadine Emulgel single application determined a significant increase of vulvar hyperemia, evaluated both clinically and instrumentally, accompanied by a significant increase of local turgor versus placebo. The volunteers reported a pleasant comfort sensation. CONCLUSIONS: The topical use of Visnadine on female external genitalia may increase regional vascularization affecting turgidity and sensorial threshold of the area of application.

Evaluation of the efficacy of a new hyaluronic acid gel on dynamic and static wrinkles in volunteers with moderate aging/photoaging.

PURPOSE: Aim of the study was to determine both clinically and by noninvasive instrumental evaluations the efficacy, tolerability and the duration of the effects of a new hyaluronic acid (HA) gel in human volunteers with moderate aging/photoaging. PATIENTS AND METHODS: Eighteen volunteers (35-55 years) were enrolled in this single-center study. The subjects underwent five visits. The first visit was at baseline to determine the adherence to the inclusion criteria, followed by the first injection of the HA-based study product, and the second visit was at 48 hours after the injection. Two months later, a second injection was given (Visit 3) followed by a subsequent visit (Visit 4) after 48 hours. The last visit (Visit 5) was performed 5 months after the first injection. Clinical and instrumental evaluations as well as self-assessment by the subjects were recorded at each visit. RESULTS: A significant improvement of wrinkles' grade around the eyes, vertical lip lines and wrinkles' severity of nasolabial folds was recorded after the first injection and the effect increased after the second injection. Aging/photoaging grade and surface microrelief improved 2 months after the first injection procedure. These clinical improvements were paralleled by amelioration of instrumental skin profilometry and optical colorimetry. The treatments were very well tolerated by the volunteers as determined by the self-grading score. CONCLUSION: The results confirm the good esthetic performance and the duration of the effect of the HA-based study product (Viscoderm® Hydrobooster) on dynamic facial wrinkles and/or static facial lines. These effects were particularly evident after the second injection and were accompanied by a good tolerability of the product.

Antiaging efficacy of melatonin-based day and night creams: a randomized, split-face, assessor-blinded proof-of-concept trial.

BACKGROUND: Skin is a complete and independent melatoninergic system. At the skin level, melatonin (Mel) acts as a relevant antioxidant and cytoprotective substance. Topical application of Mel is considered meaningful, since it can easily penetrate the stratum corneum. Exogenous Mel can be expected to represent a potent antioxidative defense system against skin aging mechanisms. Day and night creams containing Mel, carried in lipospheres (Melatosphere™), have been developed (Nutriage SPF 30 day cream and Nutriage night cream). STUDY AIM: The aim of this study was to evaluate the efficacy of a Mel-based cream as antiaging treatment. SUBJECTS AND METHODS: In a randomized, split-face, assessor-blinded, prospective 3-month study, 22 women (mean age 55 years) with moderate-severe skin aging were enrolled (clinical trial registration number: NCT03276897). Study products were applied in the morning (Nutriage day cream) and evening (Nutriage night cream) on the right or left side of the face. Primary outcomes were: 1) clinical evaluation of wrinkles' grade (crow's feet and nasolabial folds), surface microrelief, skin tonicity (resistance to pinching and traction, recovery after pinching) and skin dryness and 2) instrumental evaluation of skin roughness and 3D photographic documentation (Vectra H1 images system). Assessments of both clinical and instrumental evaluations were performed at baseline and after 1, 2 and 3 months of treatment by an investigator unaware of treatment allocation. RESULTS: All the subjects completed the study. Crow's feet was reduced significantly (p=0.05) by -15% with the creams in comparison with the non-treated side after 3 months. At the end of the study, surface microrelief (-26.5%), skin profilometry (-13%), skin tonicity (+30%) and skin dryness (-59.5%) significantly improved with active treatment. Both products were well tolerated. CONCLUSION: In women with skin aging, Mel-based creams improved significantly skin tonicity and skin hydration with a significant reduction in skin roughness, supporting the skin antiaging effect of this molecule applied topically.

The 24-hour skin hydration and barrier function effects of a hyaluronic 1%, glycerin 5%, and Centella asiatica stem cells extract moisturizing fluid: an intra-subject, randomized, assessor-blinded study.

INTRODUCTION: Moisturizing products are commonly used to improve hydration in skin dryness conditions. However, some topical hydrating products could have negative effects on skin barrier function. In addition, hydrating effects of moisturizers are not commonly evaluated up to 24 hours after a single application. Hyaluronic acid (HA) and glycerin are very well-known substances able to improve skin hydration. Centella asiatica extract (CAE) could exert lenitive, anti-inflammatory and reepithelialization actions. Furthermore, CAE could inhibit hyaluronidase enzyme activity, therefore prolonging the effect of HA. A fluid containing HA 1%, glycerin 5% and stem cells CAE has been recently developed (Jaluronius CS [JCS] fluid). STUDY AIM: To evaluate and compare the 24-hour effects of JCS fluid on skin hydration and on transepidermal water loss (TEWL) in healthy subjects in comparison with the control site. SUBJECTS AND METHODS: Twenty healthy women, mean age 40 years, were enrolled in an intra-subject (right vs left), randomized, assessor-blinded, controlled, 1-day trial. The primary end points were the skin hydration and TEWL, evaluated at the volar surface of the forearm and in standardized conditions (temperature- and humidity-controlled room: 23°C and 30% of humidity) using a corneometer and a vapometer device at baseline, 1, 8 and 24 hours after JCS fluid application. Measurements were performed by an operator blinded for the treatments. RESULTS: Skin hydration after 24 hours was significantly higher (P=0.001; Mann-Whitney U test) in the JCS-treated area in comparison with the control site. JCS induced a significant (P=0.0001) increase in skin hydration at each evaluation time (+59% after 1 hour, +48% after 8 hours and +29% after 24 hours) in comparison with both baseline (P=0.0001) and non-treated control site (P=0.001). TEWL after 24 hours was significantly lower (P=0.049; Mann-Whitney U test) in the JCS-treated area in comparison with the control site (13±4 arbitrary units [AU] vs 16±6 AU). JCS fluid significantly reduced post-stripping TEWL in comparison with baseline after 1, 8 and 24 hours (-52%, -32% and -48%, respectively). In the control site, TEWL was not reduced in comparison with baseline values at each time point's evaluation. CONCLUSION: A single application of JCS significantly improves skin hydration for up to 24 hours at the same time as improving skin barrier function.

Efficacy and tolerance of an injectable medical device containing stable hybrid cooperative complexes of high- and low-molecular-weight hyaluronic acid: a monocentric 16 weeks open-label evaluation.

BACKGROUND: An injectable medical device containing stable hybrid cooperative complexes of high- and low-molecular-weight hyaluronic acid (HA) has been developed with characteristics suited for a global improvement of facial esthetics. OBJECTIVE: To evaluate the HA product performance in improving some key facial esthetic features. The study employed clinical scales, subjective evaluations, and facial skin objective measurements. METHODS: A single Italian site treated 64 female subjects aged 38-60 years, with injections at five predetermined points, on each side of the face, with a 4-week time lapse between the first and the second product administration. Subjects were evaluated after 4, 8, 12, and 16 weeks, using validated clinical scales, subjective evaluation, and objective quantitative outcome measures. Assessment of esthetic results included photographic documentation. RESULTS: Both the clinical and subjective assessments, and the majority of objective instrumental parameters indicated an improvement throughout the study and were already significant at week 4 or 8 and were still significant at week 16 (3 months after the second treatment). Minor and temporary local skin reactions were observed in 23% of subjects at the site of the injections, and the global judgment on tolerability was good or excellent, both in the investigators' opinion and volunteers' self-evaluation. CONCLUSION: Both subjective and objective improvement of the facial parameters was consistent with the bio-remodeling purpose, and persistent and still statistically significant at the end of the study. The tolerability and safety profile of the product were judged good or excellent both by investigators and volunteers. This study supports the claim for bio-remodeling of these stable hybrid cooperative complexes of low- and high-molecular-weight HA.

Antiaging, photoprotective, and brightening activity in biorevitalization: a new solution for aging skin.

BACKGROUND: Age-related changes in the dermis can be considered the result of intrinsic factors and the consequence of environmental damage, mainly due to ultraviolet (UV) radiation from the sun (responsible for skin photoaging). The great versatility of the mesotherapy "biorevitalization" lies in the synergy between different biological effects of the active injected substances, which treats the skin in a more complete way. Several studies about biorevitalization efficacy showed good results. To date, however, objective results supported by instrumental evaluation are very sparse. PURPOSE: This study evaluated the efficacy of an injectable solution (32 mg of hyaluronic acid plus an antiaging antioxidant complex consisting of vitamins, minerals, and amino acids) in the treatment of skin aging and photoaging. METHODS: A total of 64 female volunteers (37-60 years) underwent four sessions of biorevitalization at 3-week intervals, involving multiple injections in the face (external corner of the eye and cheek), neck, décolletage, and back of the hands. The esthetic result was assessed at baseline and after 6, 9, and 12 weeks, and was established through the use of clinical and instrumental evaluations, supported by photographic documentation. Additionally, a phototest was performed to assess the effect of biorevitalization treatment on UVB-induced erythema. RESULTS: Instrumental assessment showed, as early as after the second biorevitalizing treatment, the antiaging efficacy of the tested product; there was a clinical and statistically significant improvement of profilometric parameters, skin brightness, pigmentation, and deep skin hydration. The study product induced a statistically significant decrease of the visual score of the UVB-induced erythema compared with baseline, which was statistically different from placebo. CONCLUSION: The study confirmed the well-known efficacy of biorevitalization in skin rejuvenation. The positive difference between deep and superficial skin hydration registered at the end of the trial suggested improved skin moisture retention of the stratum corneum. Furthermore, the obtained results suggest that the injected product could intervene at different moments of the skin pigmentation process by activating an intrinsic photoprotective mechanism and improving skin pigmentation quality. It may be that these processes employ common mechanisms in which antioxidants could play a pivotal role. This last hypothesis deserves further investigation.

An innovative approach to the topical treatment of acne.

Acne is characterized by primary lesions on the face, chest, and back, and by a variety of other signs and symptoms. In particular, acne inflammatory lesions result from Propionibacterium acnes colonization and are of particular relevance as they can cause permanent scarring. Acne also causes significant psychological morbidity in affected patients. Products currently available for the treatment of acne include systemic and topical treatments. As these products can cause severe side effects, new, innovative therapies are needed. Farmaka Acne Cream (FAC) is a novel, film-forming cream developed to treat mild and moderate acne. In vitro studies have demonstrated that FAC is as effective as 5% benzoyl peroxide in inhibiting growth of P. acnes. In 32 subjects with mild or moderate acne, FAC reduced all the major signs and symptoms of the disease. These included itching, erythema, and scaling, as well as reductions in the numbers of papules, pustules, and open and closed comedones. Acne severity improved in 38% of subjects, while none worsened. FAC was found to be effective in controlling sebum secretion, and was non-comedogenic. Most subjects (90%) reported tolerability as good or very good, while clinical efficacy and cosmetic acceptability were judged as good. For assessment of contact sensitization and photosensitization, FAC was applied daily to the backs of 29 subjects in two symmetric areas for 10 days. Using a solar stimulator, one minimal erythema dose was delivered to one side of the back from days 11 to 13. The four different subareas of treated/untreated and irradiated/nonirradiated and combinations thereof were compared. No cases of contact sensitization or photosensitization were observed, and FAC is considered safe for use in intense sunlight. In vitro and in vivo studies provide evidence for the safety and clinical benefits of FAC, a promising candidate for the treatment of mild and moderate acne.

Computerized image analysis of nails affected by fungal infection: evaluation using digital photographs and manually defined areas.

Despite the relevant increase in clinical trials on the efficacy of various systemic and/or topical antifungal agents in onychomycosis therapy, the evaluation of the results is largely subjective. The aim of this study was to set up and ensure an objective, reproducible and reliable method to measure nail plate involvement in onychomycosis. In order to validate a specifically designed software for the computerized image analysis of affected areas of the nail, standardized clinical pictures of onychomycosis were prepared by six different clinicians using a sample of 11 affected nails. Diseased areas and total nail plates were measured both on the clinical pictures and on their drawings traced by the different clinicians on transparent tapes adhering to sample nails. The computerized procedure was undertaken by a trained operator who was not a dermatologist. The variation coefficients of measurements on clinical pictures (automatically detected) and on drawings were compared. In addition, the agreement between automatic evaluation and drawing was evaluated by means of Bland-Altman analysis. To consider the effect of possible variations linked to different operators using the computerized method, 11 clinical pictures (one for each clinical case considered) were selected and submitted to computerized image analysis by six different trained operators. The computerized detection of affected nail areas showed a coefficient of variation (vc=8.5%) lower than that observed on drawings (vc=14.7%). The two methods showed appreciable agreement, as demonstrated by Bland-Altman plot. The coefficient of variation of image analysis conducted by six different operators was very low for the total area calculation (vc=0.9%) and acceptable for pathological area detection (vc=4.8%). Based on the results obtained, we conclude that automatic evaluation is a reliable and helpful method for the measurement of the clinical involvement of the nail plate in onychomycosis and for the evaluation of therapies, since it can increase the objectivity and reproducibility of data. However, in a minority of difficult cases, expert dermatological evaluation is needed.

Preliminary open-label clinical evaluation of the soothing and reepithelialization properties of a novel topical formulation for rosacea.

BACKGROUND: Rosacea is a common, incurable skin barrier disorder characterized by relapses and remissions. PURPOSE: To evaluate the efficacy of Farmaka Rosacea Cream (FRC), a novel topical formulation for rosacea. METHODS: This single-center, open-label pilot study comprised a single-dose substudy in 20 healthy subjects and a long-term, repeat-dose substudy in 22 subjects with rosacea. The 2-hour, controlled, single-dose substudy assessed the soothing and reepithelialization properties of FRC after stripping-induced erythema based on the erythema index, transepidermal water loss, skin hydration, and clinical assessments of erythema. In the long-term substudy, subjects applied FRC twice daily for 8 weeks. Clinical assessments included vascular and pigmentary homogeneity and erythema and hemoglobin indices. Subjects completed questionnaires to assess FRC efficacy and cosmetic acceptability. RESULTS: Greater reductions were seen in FRC-treated areas compared with untreated areas for the erythema index (-16% versus -8%; P<0.001) and mean transepidermal water loss (-35.8% versus -10.1%; P<0.001) 30 minutes after stripping. Significant improvements over untreated areas were maintained 2 hours after stripping. Skin hydration and clinical erythema assessments also indicated that FRC soothed rosacea symptoms and promoted skin reepithelialization. Erythema and hemoglobin indices were significantly reduced from baseline after 4 and 8 weeks of treatment. Clinically assessed parameters were significantly improved following FRC application. Subjects assessed FRC positively. CONCLUSION: Improvement of rosacea symptoms was noted with FRC application. The main film-forming ingredients of FRC (trehalose, cholesterol, ceramide, and fatty acids), combined with other soothing and calming ingredients and ultraviolet filters, could explain its efficacy.