Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double-blind, randomized, vehicle-controlled study.

INTRODUCTION: Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (active shampoo) has been developed for psoriasis-prone scalp. OBJECTIVE: To assess the efficacy and tolerability of an active shampoo in subjects with mild to moderate scalp psoriasis. MATERIALS AND METHODS: A single-center, randomized, double-blind, vehicle-controlled study was conducted on 67 adults with mild to moderate psoriasis. The active shampoo or its vehicle were applied daily for 14 days and 3 times/week for another 14 days. Assessments included the Psoriasis Scalp Severity Index (PSSI), Investigator Global Assessment (IGA), calculated total surface affected hair, scalp greasiness, irritation, and assessed scalp dermatitis-specific quality-of-life issues using SCALPDEX and product acceptability. RESULTS: The active shampoo significantly (p < 0.05) reduced the PSSI by 39.0%, 37.2%, 63.0%, and 69.0% immediately after washing compared to a 22.8%, 5.5%, 19.6%, and 13.0% with the vehicle at Days 1, 8, 15, and 30, respectively. SCALPDEX items, IGA, and irritation significantly (p < 0.05) reduced with the active shampoo. Hair and scalp greasiness improved continuously with both products until Day 21. Subject-reported symptom scores paralleled the positive evolution of clinical signs. The active shampoo was well tolerated, subjects were highly satisfied and had an improved QoL. CONCLUSION: The active shampoo significantly improved clinical signs, symptoms, and QoL of mild-to-moderate scalp psoriasis compared to the vehicle. It was very well tolerated and highly appreciated by the subjects.

Effects of Starch Incorporation on the Physicochemical Properties and Release Kinetics of Alginate-Based 3D Hydrogel Patches for Topical Delivery.

The development of printable hydrogel inks for extrusion-based 3D printing is opening new possibilities to the production of new and/or improved pharmaceutical forms, specifically for topical application. Alginate and starch are natural polysaccharides that have been extensively exploited due to their biocompatibility, biodegradability, viscosity properties, low toxicity, and relatively low cost. This research work aimed to study the physicochemical and release kinetic effects of starch incorporation in alginate-based 3D hydrogel patches for topical delivery using a quality by design approach. The incorporation of a pregelatinized starch is also proposed as a way to improve the properties of the drug delivery system while maintaining the desired quality characteristics. Critical material attributes and process parameters were identified, and the sensitivity and adequacy of each parameter were statistically analyzed. The impact of alginate, starch, and CaCl2·2H2O amounts on relevant quality attributes was estimated crosswise. The amount of starch revealed a synergetic impact on porosity (p = 0.0021). An evident increase in the size and quantity of open pores were detected in the as printed patches as well as after crosslinking (15.6 ± 5.2 µm). In vitro drug release studies from the optimized alginate-starch 3D hydrogel patch, using the probe Rhodamine B, showed an initial high burst release, followed by a controlled release mechanism. The results obtained also showed that the viscoelastic properties, printing accuracy, gelation time, microstructure, and release rates can be modulated by varying the amount of starch added to the system. Furthermore, these results can be considered an excellent baseline for future drug release modulation strategies.

Autologous pure platelet-rich plasma injections for facial skin rejuvenation: Biometric instrumental evaluations and patient-reported outcomes to support antiaging effects.

BACKGROUND: During skin aging, a degeneration of connective tissue and decrease in hyaluronic acid polymers occur. Since platelet-rich plasma (PRP) contains growth factors and various cytokines, it was hypothesized that it could play a role in fibroblast activation and type I collagen expression in human fibroblasts. OBJECTIVES: This study was performed to assess the efficacy of autologous PRP injections for facial skin rejuvenation, measured by biometric instrumental evaluations and patient-reported outcomes. PATIENTS AND METHODS: Patients signed an informed consent form. The EmCyte PurePRP® system technology was used to produce neutrophil-poor PurePRP. The efficacy of the procedures was assessed by biometric parameters, and a patient outcome a self-assessment questionnaire on each visit and at 6-month follow-up. RESULTS: Eleven volunteers were included in the study, receiving 3 PurePRP® treatments. A significant decrease in brown spot counts and area (P < 0.05) was seen after 3 months. Wrinkle count and volume were significantly reduced (P < 0.05 for total wrinkle appearance). Skin firmness parameters were significantly improved. Skin redness was significantly improved after 169 days post-therapy for both the nasolabial and malar areas. A decrease in SLEB thickness was already noted at 2 months after the first injection, with an increase in SLEB density (P < 0.05 for both parameters), without affecting subcutaneous fat thickness. Self-assessment at 6-month follow-up revealed an average satisfaction score of >90%. CONCLUSIONS: A series of 3 PurePRP injections at 6-month follow-up resulted in significant skin rejuvenation as demonstrated by biometric parameters and confirmed by patient self-assessment score.

In vivo assessment of peripheral vascular function by tcpO2 and skin blood flow modelling.

There are multiple techniques and methods to assess peripheral vascular function in vivo but not without limitations. More discriminative, sensitive and also practical evaluation strategies are needed to fully characterize the peripheral vascular function. In the present work, a new quantitative descriptor, the 'elimination half-life time' was developed from flow-related variables as a non-invasive microcirculatory rate parameter to describe vascular dynamics. Fifty-four healthy volunteers and six type 2 diabetic patients, both genders, were submitted to a dynamical procedure consisting in the inhalation of a 100% saturated atmosphere of oxygen for 10 min. The tcpO(2) and microcirculatory blood flow [Laser Doppler Flowmetry (LDF)] were measured in a randomly selected leg with a Periflux 5000 system before, during and after the procedure. A monocompartmental model was adjusted to tcpO(2) and LDF data. The tcpO(2) constant elimination rate, expressed as the Oxygen elimination half-life, was used as an indicator of the vulnerability of peripheral tissue and compared in healthy versus non-healthy individuals. Under normal conditions, the saturated ventilation increases the tissue's O(2) availability, as an expression of the natural capacity to adjust the tissue hemodynamics to new metabolical/perfusion conditions. Diabetic patients are expected to suffer vascular impairment and ischemia. Under O(2) overloading conditions, those hypoxic territories tend to uptake all the delivered oxygen, expressed as a significant increase in the O(2) elimination half-life. This approach allows to propose 'elimination half-life time' as the first quantitative descriptive parameter combining miogenic, hemodynamic and metabolic aspects of the microcirculatory physiology and to help to identify the individual's vascular vulnerability.

An experimental in vivo model to characterize "heavy legs" symptom in topical formulations.

The "Heavy legs" symptom is regarded as an early expression of chronic venous failure, estimated to affect 40% of the population in developing countries. A new methodology is proposed to approach the "tired or heavy legs" symptom. Seven females with this complaint applied a standard topical formulation during 28 days in one leg randomly chosen. Local blood flow records were obtained instantaneously and during postural change with a laser doppler flowmeter (LDF). High-frequency sonography and local morphometry were also obtained at Days 0, 14, and 28. When compared with D0, LDF values present a significant decrease of both basal and dynamical values after Day 14 and Day 28 suggesting that this effect may result from the formulation application, also involving the related massage. Centimetric measurements and sonographic analysis also supported those inferences. The proposed methodology can evaluate the dynamical changes of "heavy legs" symptom and eventually be very useful to assess the related claim support.

Exploring the influence of skin perfusion on transepidermal water loss.

BACKGROUND: Eventual relationships between the vascular function and transepidermal water loss (TEWL), in vivo,have not been entirely explored. By promoting local perfusion alterations through a well-known challenge test, the'tourniquet-cuff occlusion' manoeuvre, the present study searches for other dynamical factors influencing the cutaneous barrier, further exploring the applicability of these flow-related variables in dermatological research. METHODS: By applying the tourniquet-cuff manoeuvre to a group of healthy volunteers (n= 20), transcutaneous (tc)gases (pO2-pCO2), LDF (laser doppler flowmetry) and TEWL were considered as representing the dynamical aspects under study and measured non-invasively. RESULTS AND CONCLUSION: An haemodynamical relationship between tcpO2 and LDF in the post-occlusive period was clearly identified, defining the autoregulatory index as a numerical descriptor of the local metabolic-flow adjustment under stress. TEWL was also significantly affected by the manoeuvre, especially during the post-occlusive period,although no significant relationships between TEWL and other tc variables could be found. The present findings seem to suggest that, under the present experimental conditions, local haemodynamics may also influence TEWL measurements and the skin barrier.

Quantitative description of human skin water dynamics by a disposition-decomposition analysis (DDA) of trans-epidermal water loss and epidermal capacitance.

BACKGROUND: In vivo water assessment would greatly benefit from a dynamical approach since the evaluation of common related variables such as trans-epidermal water loss or "capacitance" measurements is always limited to instantaneous data. Mathematical modelling is still an attractive alternative already attempted with bi-exponential empirical models. A classical two-compartment interpretation of such models raises a number of questions about the underlying fundamentals, which can hardly be experimentally confirmed. However, in a system analysis sense, skin water dynamics may be approached as an ensemble of many factors, impossible to discretize, but conceptually grouped in terms of feasible properties of the system. The present paper explores the applicability of this strategy to the in vivo water dynamics assessment. METHODS: From the plastic occlusion stress test (POST) skin water balance is assessed by modelling trans-epidermal water loss (TEWL) and "capacitance" data obtained at skin's surface. With system analysis (disposition-decomposition analysis) the distribution function, H(t), modelled as a sum of exponential terms, covers only the distribution characteristics of water molecules traversing the skin. This may correspond macroscopically to the experimental data accessed by "corneometry". Separately, the hyperbolic elimination function Q(TEWL) helps to characterise the dynamic aspects of water influx through the skin. DISCUSSION AND CONCLUSION: In the observable range there seems to be a linear relationship between the net amount of water lost at the surface by evaporation, and the capability of the system to replenish that loss. This may be a specific characteristic of the system related to what may be described as the skin's "intrinsic hydration capacity" (IHC) a new functional parameter only identified by this strategy. These new quantitative tools are expected to find different applicabilities (from the in vivo skin characterisation to efficacy testing) contributing to disclose the dynamical nature of the skin water balance process.