Fabrication and efficacy assessment of combination of brimonidine and ivermectin for treatment of papulopustular rosacea.

BACKGROUND & AIM: Rosacea is a chronic inflammatory, multifactorial disease for which combination therapy could be an effective treatment. In this study, we evaluate the effect of the combination therapy of brimonidine 0.33% and ivermectin 1% as a single cream for the treatment of papulopustular rosacea. METHOD: A stable and appropriate formulation was prepared by adding the aqueous phase to the lipid phase while being stirred. The stability and physicochemical properties of the formulation were evaluated under accelerated conditions. Twelve patients (36-60 years) with mild to moderate papulopustular rosacea and a Demodex count of five or more were treated with the combination of brimonidine 0.33% and ivermectin 1% cream. Clinician's Erythema Assessment (CEA), Patients Self-Assessment (PSA), skin erythema (ΔE) and lightness (ΔL), and skin biophysical parameters including transepidermal water loss (TEWL), skin hydration, pH, and sebum content, as well as erythema and melanin index and ultrasound parameters, were measured before treatment and 4 and 8 weeks after. Adverse drug reactions were also recorded. RESULTS: CEA and PSA decreased significantly from 3 to 2 after 8 weeks, respectively (p-value = 0.014 for CEA and 0.010 for PSA). ΔE and ΔL, as well as skin erythema index and TEWL improved after 8 weeks of treatment (p < 0.05). Two patients withdrew from the study in the first week because of local adverse effects; one developed flushing following treatment and left the investigation after 4 weeks and another patient withdrew from the study after 4 weeks due to deciding to become pregnant. CONCLUSION: Eight-week treatment with the combination of brimonidine 0.33% and ivermectin 1% was shown to be effective for improvement of erythema and inflammatory lesions in mild to moderate papulopustular rosacea.

Effects of Cosmetic Preservatives on Healthy Facial Skin Microflora.

Objective: The present study was designed to evaluate the effects of seven common preservatives used in Iranian cosmetic products on facial skin microflora. Methods: Fifteen healthy volunteers, aged 20 to 35 years, were recruited. Three symmetrical sites from the cheeks of each volunteer were selected and samples were collected. DNA was extracted from the culture using the boiling method. The fungi's internal transcribed spacer (ITS) region was amplified using ITS1/ITS4 primers, for 16s to identify bacteria and Staphylococcus specific primers. The effects of the preservatives were assessed based on growth on broth culture media. Results: Primary identification was based on yeast on CHROM agar, in which 15 different yeasts were isolated; then, PCR was used to identified the species as: C. albicans (n: 14; 93%), C. orthopsilosis (n: 1; 7%). One primary identified yeast on Dixon media was precisely differentiated as M. furfur using the PCR method. Fifteen primary identified cocci on tryptic soy agar media were identified as Staphylococcus epidermis. All the preservatives showed to inhibit the growth of isolated fungi, but not that of bacterial microflora. Conclusion: The present study showed preservatives in cosmetic products can alter skin microflora while also preventing the growth of pathogenic bacteria.

Cost-utility and budget impact analysis of adding-on apremilast to biologic therapy in the treatment of moderate to severe plaque psoriasis, an Iranian payer perspective.

BACKGROUND AND PURPOSE: Plaque psoriasis is a chronic inflammatory disease with skin manifestations that affect the patients' quality of life negatively. The prevalence of psoriasis is approximately 2-3% worldwide and appears to be still on the increase. Due to the stigma problems, psoriasis has a significant effect on one's life that is often overlooked. The current study aimed to conduct the cost-utility evaluation and budget impact analysis of adding-on apremilast ahead of biologic therapy in the treatment of moderate to severe plaque psoriasis. The psoriatic patients who did not undergo the conventional systemic therapy were eligible to enter the defined sequences. EXPERIMENTAL APPROACH: An excel-based Markov model with 40 cycles of 3 months, each of which was adopted to compare the outcomes of each exclusively administered sequence in the treatment of moderate to severe plaque psoriasis. Two exclusive therapeutic sequences were considered. In the first sequence, apremilast was followed by biologics and in the second one, biologics were administered initially without apremilast. The results were extrapolated up to 10 years. The designed Markov model was also used in budget impact analysis. The cost-saving potential of the new treatment was accounted for the next 5 years. FINDINGS/RESULTS: Incremental cost and incremental effect were reported in the base case scenario. Using the sequence consisting apremilast provided an additional 0.10 quality-adjusted life years and decreased total costs by about 11,100 USD per patient. These results were in line with the findings from sensitivity analysis. The cost-saving over 5 years is estimated to be around 30 million dollars for the Iran market following the use of the new treatment. CONCLUSION AND IMPLICATIONS: In the treatment of moderate to severe plaque psoriasis, apremilast supplementation prior to biological treatments is more cost-effective than biological treatment alone.

Caspofungin resistance in clinical Aspergillus flavus isolates.

INTRODUCTION AND AIMS: The present study was conducted to determine the candidate genes involved in caspofungin (CAS) resistance in clinical isolates of Aspergillus flavus (A. flavus). MATERIALS AND METHODS: The antifungal susceptibility assay of the CAS was performed on 14 clinical isolates of A. flavus using the CLSI-M-38-A2 broth micro-dilution protocol. Since CAS had various potencies, the minimum effective concentration (MEC) of anidulafungin (AND) was also evaluated in the present study. The FKS1 gene sequencing was conducted to assess whether mutations occurred in the whole FKS1 gene as well as hot spot regions of the FKS1 gene of the two resistant isolates. A complementary DNA-amplified fragment length polymorphism (CDNA-AFLP) method was performed to investigate differential gene expression between the two resistant and two sensitive clinical isolates in the presence of CAS. Furthermore, quantitative real-time PCR (QRT-PCR) was utilized to determine the relative expression levels of the identified genes. RESULTS: No mutations were observed in the whole FKS1 gene hot spot regions of the FKS1 genes in the resistant isolates. A subset of two genes with known biological functions and four genes with unknown biological functions were identified in the CAS-resistant isolates using the CDNA-AFLP. The QRT-PCR revealed the down-regulation of the P-type ATPase and ubiquinone biosynthesis methyltransferase COQ5 in the CAS-resistant isolates, compared to the susceptible isolates. CONCLUSION: The findings showed that P-type ATPase and ubiquinone biosynthesis methyltransferase COQ5 might be involved in the CAS-resistance A. flavus clinical isolates. Moreover, a subset of genes was differentially expressed to enhance fungi survival in CAS exposure. Further studies are recommended to highlight the gene overexpression and knock-out experiments in A. flavus or surrogate organisms to confirm that these mentioned genes confer the CAS resistant A. flavus.

Long-term effects of two 24-hour moisturizing products on skin barrier structure and function: A biometric and molecular study.

INTRODUCTION: Recently, there are a few moisturizers showing hydrating effects up to 24 hours after single application. Aquaporin 3 might be associated with the degree of skin hydration. We aimed to assess the effects of two brands of 24-hour moisturizers on the skin barrier function, as well as the AQP3 gene expression. METHOD: Two moisturizers were applied once daily by 20 participants age 36.15 ± 9.55 years. Upper right and left forearms were randomly assigned to application of each product, whereas the right lower forearm served as control site for application of a cream base formulation. Biophysical assessments including trans epidermal water loss (TEWL), skin hydration, pH, surface lipids, and elasticity parameters were performed before intervention, 1, 4, and 24 hours after single application, following 2 weeks daily application and 1 week after termination of use. Also 5-mm punch biopsies were performed from application sites of product B and cream base formulation in for five participants after 2 weeks of application. RESULTS: A single treatment with both products led to 24-hour increase in skin moisture in comparison with the control site (P-value <.01). Daily application of both products for 14 days also led to significant improvement in skin moisture (P-value <.01), TEWL (P-value <.01), and elasticity parameters. The increase in skin hydration was associated with upregulation of AQP3 gene expression in treated area for one of the formulations (P-value = .04). CONCLUSION: The tested 24-hour moisturizers only need to be applied once daily to improve skin barrier function and hydration and up-regulate AQP3 mRNA expression.

Efficacy of Cetirizine 1% Versus Minoxidil 5% Topical Solution in the Treatment of Male Alopecia: A Randomized, Single-blind Controlled Study.

PURPOSE: Prostaglandins play a pivotal role in modulating hair growth cycle. Prostaglandin F2α and prostaglandin E have stimulating and prostaglandin D has inhibitory effects on hair follicle. Cetirizine inhibits release of prostaglandin D2 and stimulates the release of prostaglandin E2. In the present study, the efficacy and safety of twice daily application of topical cetirizine 1% versus minoxidil 5% solutions for 16 weeks were compared in male androgenetic alopecia (AGA). METHODS: Forty men, aged 18 to 49 years, were randomly divided into two equal groups to apply either cetirizine 1% or minoxidil 5% solutions. The study was divided into two phases, a 16-week treatment phase either with cetirizine or minoxidil (anagen phase), followed by an 8-week drug-free (telogen phase) with a follow-up when patients used placebo. Efficacy outcomes included the change in total hair density, vellus and terminal hair density, hair diameter and the percentage of hair in anagen and telogen phases from baseline in 16 and 24 weeks. RESULTS: After 16 weeks, we observed a significant increase in total and vellus hair density in both minoxidil and cetirizine groups, but the improvement was much higher in the minoxidil group. The percentage of hair in the anagen phase also increased in both groups after 16 weeks of treatment, but then diminished after 8 weeks of placebo consumption. No significant adverse reactions associated with the administration of cetirizine solution were reported. CONCLUSION: Cetirizine 1% solution was effective in hair growth without any complications for treatment of male AGA.

Short-term effects of exposure to air pollution on biophysical parameters of skin in a panel of healthy adults.

Little research on impact of air pollution on human skin is available. We aimed to clarify the association between acute exposure to criteria air pollutant with biophysical characteristics of the skin. We followed a panel of 20 volunteers free of any skin diseases in skin evaluation study in Tehran, Iran from April 2017 to April 2018. Two distinct body parts including middle forehead and inside the right upper arm were evaluated at six time periods. The associations of the weighted averages of personal exposure to air pollutants at 24 hours up to 6 days, and multiday average before the skin assessment with biophysical characteristics of normal skin including sebum content, hydration, transepidermal water loss (TEWL), erythema index, melanin index, pH, temperature, friction, and elasticity were assessed in a random intercept linear mixed effects modeling approach. We observed significant positive association for the arm sebum content with exposure to PM2.5 , and SO2 ; the arm and forehead TEWL with NO2 , the arm and forehead friction with O3 , and forehead hydration with PM2.5 and PM10 in early lags. We found significant negative association for the arm melanin index, elasticity, and erythema index with exposure to O3 ; and forehead elasticity with PM2.5 and PM10 . Our results provided some evidence that short-term exposure to particulate and gaseous air pollutants have detrimental effects on biophysical and biomechanical properties of skin. The association varied across body area and depended on pollutant type.

Biophysical Measurements and Ultrasonographic Findings in Chronic Dermatitis in Comparison with Uninvolved Skin.

BACKGROUND: Nowadays noninvasive techniques are performed to evaluate the biophysical properties of skin in vivo. AIMS: The aim of this study was to evaluate the biophysical and ultrasonographic properties of skin in chronic contact or atopic dermatitis to provide better insight into pathogenesis, diagnosis, and treatment response. MATERIALS AND METHODS: The stratum corneum hydration, transepidermal water loss (TEWL), pH, erythema, melanin, sebum, friction, temperature, elasticity parameters (R0, R2, and R5), the thickness and echo-density of epidermis, dermis, and subepidermal low-echogenic band (SLEB) were measured on lesional, perilesional, and symmetrical skin of 22 chronic dermatitis patients. The average of perilesional and symmetrical skin values (control) was compared with lesional values. RESULTS: Stratum corneum hydration (P<0.001), friction (P=0.02), sebum (P=0.01), and R0 (P<0.001) were significantly lower in lesion, TEWL (P=0.03), pH (P=0.001), erythema (P=0.004), and temperature (P=0.04) were significantly higher in lesion. The thickness of epidermis (P=0.002), dermis (P=0.034), and SLEB (P<0.001) were significantly higher in lesion; and the echo-density of dermis (P<0.001) and SLEB (P<0.001) was significantly lower in lesion. CONCLUSION: Chronic contact and atopic dermatitis are characterized by certain changes in biophysical and biomechanical properties of the skin. The evaluation of these parameters might be useful in the early diagnosis and assessment of treatment response.

Cigarettes Smoking and Skin: A Comparison Study of the Biophysical Properties of Skin in Smokers and Non-Smokers.

BACKGROUND: Tobacco smoke is toxic for cells and could be a damaging factor to skin. The purpose of this study was to compare the biophysical properties of skin in smokers and non-smokers. MATERIALS AND METHODS: The study population consisted of 28 current smokers and 24 non-smokers. The hydration of the stratum corneum, trans epidermal water loss, pH, erythema, melanin content, sebum, friction and elasticity parameters (R0, R2, R5) of skin, epidermis and dermis thickness and echo-density were measured on middle forehead, right cheek and right inner arm of participants. Also volume, surface area and depth of right nasolabial folds were measured. The mean of these values in smokers were compared with non-smokers by independent sample T- test. RESULTS: Gross elasticity was significantly lower in smokers on forehead (p= 0.048). Thickness of epidermis was higher in smokers in all measured sites but the differences were not statistically significant. Thickness of dermis was higher in smokers in all measured sites too, but only the difference on cheek was statistically significant (p= 0.009). Density of epidermis was lower in smokers in all measured sites, but only the difference on forehead was statistically significant (p= 0.019). Density of dermis was lower in smokers in all measured sites, but only the difference on arm was statistically significant (p= 0.028). Volume and area of nasolabial folds were higher in smokers, but only the difference of area was statistically significant (p = 0.031). CONCLUSION: Tobacco smoking could affect the biophysical parameters of skin, especially thickness and density of dermis and epidermis and nasolabial folds.

Preparation and characterization of Aloe vera acetate and electrospinning fibers as promising antibacterial properties materials.

In this work, the anti-bacterial effect of Aloe vera derivate fibers produced by the electrospinning method was reported. Aloe vera Polyvinylpyrrolidone (Av/PVP) and Aloe vera acetate-Polyvinylpyrrolidone (AvAc/PVP) electrospun fibers were prepared with different concentrations and their microstructure and mechanical properties were studied. Various methods such as differential scanning calorimetry (DSC), thermogravimetry analysis (TGA), water contact angle (CA) tests, Fourier-Transform Nuclear Magnetic Resonance (FT-NMR), scanning electron microscope (SEM), X-ray diffraction (XRD), CHNSO and Fourier-Transform Infrared Spectroscopy (FT-IR) were used to characterize prepared samples. (Av/PVP) electrospun fibers were prepared with different concentrations (6-10 wt%) of PVP and 0.2 wt% Av blended and tested in medicinal herb for wound healing, antibacterial and anti-inflammatory properties. For further study, the effect of AvAc film on the properties of composite film was studied. AvAc increased the thermal stability and crystallite size percentage of samples. Antibacterial and antiviral test studies on the scaffold displayed no bacterial and viral growth. These results suggest that AvAc/PVP scaffolds could be promising candidates for wound healing applications.

A Phase II Trial to Assess the Safety and Efficacy of a Topical Repair Cream Containing Skin-identical Ceramide Complex in Patients with Contact Dermatitis.

Background: Contact dermatitis is a common skin condition observed by dermatologists, presenting a burden on healthcare systems. Recently, there has been a trend in producing skin-identical topical preparations for the repair of skin. However, there is a limited number of experimental studies to assess the safety and efficacy of this products. Objective: This study assessed the clinical efficacy and safety of a skin-identical ceramide complex cream (Dermalex Repair Contact Eczema; Omega Pharma, Nazareth, Belgium) in the treatment of contact dermatitis. Design: This was a Phase II, before-after trial. Setting: This study was conducted at the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL) at Tehran University of Medical Sciences in Tehran, Iran. Participants: Fifteen patients with contact dermatitis (8 men and 7 women) between the ages of 25 and 62 years (median age: 36.4 years) were enrolled in this study. Measurements: Changes were assessed using six skin biophysical parameters (transepidermal water loss [TEWL], stratum corneum [SC] hydration, melanin index, erythema index, skin pH, and skin friction), Physician Global Assessment (PGA) score, and Three-Item Severity (TIS) score at baseline, Week 2, and Week 4 of the study. Results: Skin hydration and TIS showed a statistically significant improvement after treatment with study cream (p=0.023 and p=0.007, respectively). Although the reduction in TEWL was not significant, a slight decrease was observed at Week 4. Conclusions: The skin-identical ceramide complex cream improved contact dermatitis with a decrease in TIS and an increase in skin hydration, implying a repair of the skin barrier.

Combination of Fractional Radiofrequency and Thermo-Contraction Systems for Facial Skin Rejuvenation: A Clinical and Histological Study.

BACKGROUND: Radiofrequency energy systems are popular options in the treatment of skin laxity and wrinkles. Fractional radiofrequency devices (FRFs) have increased the efficacy and safety. The thermo-contraction (TC) system is also a novel technology that can promote a marked lifting effect. OBJECTIVES: This trial was done to assess the safety and efficacy of a combination treatment using the FRF system and TC for facial skin rejuvenation. METHODS: Fifteen female volunteers (mean age, 47.07 ± 8.83 years) received 3 FRF and 6 TC bipolar treatments in 3 weeks. Assessment methods included wrinkle grading by independent investigator using Glogau wrinkle scoring, objective measurement of depth, area, and volume of right nasolabial fold (using the VisioFace CSI software), thickness and echo-density of the dermis (using high-frequency ultrasound), and measurement of the skin biophysical parameters before and 3 months after last treatment. Histological assessment was also performed on 5 volunteer participants. RESULTS: The clinical evaluation showed a significant improvement in Glogau wrinkle scoring after 3 months (P value, 0.041). The area and volume of nasolabial folds were also significantly reduced (P values, 0.026 and 0.031, respectively). Skin ultrasound showed a significant increase in echo-density of the dermis, which was confirmed by histological findings of an increase in dermal collagen content. Adverse reactions were all transient and mild in severity, and subjects were "moderately satisfied" with the treatment (Likert scale, 3.6 out of 5). CONCLUSIONS: The results of this trial showed that a combination therapy by FRF and TC bipolar systems is efficient and safe for facial skin rejuvenation.

Comparison of linoleic acid-containing water-in-oil emulsion with urea-containing water-in-oil emulsion in the treatment of atopic dermatitis: a randomized clinical trial.

BACKGROUND: Application of topical moisturizers is an essential part of the management of atopic dermatitis (AD). Linoleic acid (LA), the most abundant fatty acid in the epidermis, and its derivatives have an essential role in the structure and function of the epidermal barrier, and their defects are prominent in AD. The aim of this study was to compare the efficacy and safety of two cosmetic products containing either LA or urea in patients with AD. PATIENTS AND METHODS: A total of 20 patients with AD who met the eligibility criteria and provided written informed consents were enrolled in this randomized, intra-individual split-body, single-center trial. Symmetrical lesions of patients were randomized for treatment with LA- or urea-containing water-in-oil (w/o) emulsions applied two to three times daily for 4 weeks. The efficacy of the two products was evaluated by local Scoring Atopic Dermatitis (SCORAD) of both lesions and also patient (or guardian) satisfaction. In addition, trans-epidermal water loss (TEWL), stratum corneum (SC) hydration, pH, sebum, temperature, erythema, melanin content, and ultrasonographic thickness and echo density of epidermis and dermis were measured before, and 2 and 4 weeks after, treatment. RESULTS: Four weeks of treatment with the LA-containing product resulted in a significant decrease in local SCORAD, TEWL, erythema, and echo density of dermis, as well as an increase in SC hydration compared to baseline. The urea-containing product also reduced the local SCO-RAD and echo density of dermis and increased SC hydration. In contrast to the LA-containing product, changes in TEWL and erythema were not significant. Moreover, the reduction of erythema was significantly higher in the LA-containing product-treated side compared to the urea-containing product-treated side (p = 0.006). CONCLUSION: Both LA- or urea-containing w/o emulsions can significantly improve barrier dysfunction and clinical severity of AD. In agreement with literature, it was confirmed that an LA-containing w/o emulsion exhibited erythema-reducing effects. Since emollients should be used on a regular basis, patients should choose a product by individual preference following recommendation by their dermatologists.

Assessment of the Efficacy and Safety of Hyaluronic Acid Gel Injection in the Restoration of Fullness of the Upper Lips.

BACKGROUND AND AIM: Lips have a significant role in face aesthetic perception, and lip augmentation is one of the most commonly requested aesthetic procedures. Non-permanent dermal fillers, such as hyaluronic acid (HA), are used for augmenting the lips. This article presents the results of Phase II, before - after designed study, assessing the safety and efficacy of a soft tissue HA filler, for upper lip augmentation. MATERIALS AND METHODS: Investigators treated 10 healthy adult women 28-45 years old, using a single injection of Hyamax Kiss soft tissue HA filler (a product from Hyamed Laboratories, Switzerland) for upper lip augmentation. The primary efficacy endpoint was an increase in lip fullness at least one grade on Medicis Lip Fullness Scale at 2, 12 and 24 weeks post-treatment. Furthermore, the effectiveness and durability of filler were assessed using a 5-point Investigator's Global Assessment (IGA). Adverse events and volunteers' satisfaction were reported using visual analog scale. RESULTS: Response to treatment (as defined above) after 2, 12 and 24 weeks were observed in 80%, 70% and 80% of patients, respectively. No statistical difference was found in response to treatment rate between follow-up visits (P = 0.83). The mean value of IGA score in weeks 2, 12 and 24 were 3.4 ± 0.96, 3.3 ± 0.67 and 3.3 ± 0.67, respectively. The study subjects were almost all satisfied with their lip improvement. Reported adverse effects were temporary and mostly mild in severity. CONCLUSION: Soft tissue HA filler tested in this study was well tolerated, efficient and durable when used for upper lip augmentation.

Safety Assessment of Tretinoin Loaded Nano Emulsion and Nanostructured Lipid Carriers: A Non-invasive Trial on Human Volunteers.

BACKGROUND AND AIM: Topical application of tretinoin (TRE) is followed by a high incidence of side effects. One method to overcome the problem is loading TRE into lipid nanoparticles. The potential safety of the nanoparticle materials has been always considered as a major concern. In this in vivo study, changes in human skin biophysical parameters including hydration, TEWL, erythema, and pH have been used to determine the safety of tretinoin loaded nano emulsion (NE) and nanostructured lipid carriers (NLC). METHOD: TRE loaded NE and NLC were prepared using a high pressure homogenizer. Skin biophysical parameters were measured on the volar forearms of twenty healthy volunteers, before and after applying TRE-NE and TRE-NLC lotions. All the measurements were done using respective probes of MPA 580Cutometer®. RESULT: We obtained particles of nanometric size (<130 nm) with narrow distribution and optimal physical stability. None of the formulations made any statistically significant change in any of the measured skin properties. P-values were 0.646, 0.139, 0.386, 0.169 after applying TRE-NE and 0.508, 0.051, 0.139, 0.333 after applying TRE-NLC, respectively. CONCLUSION: Both formulations are reasonably safe to apply on human skin and topical application of TRE-NE and TRE-NLC had almost similar effects on skin biophysical parameters.

Efficacy and safety of 5% minoxidil topical foam in male pattern hair loss treatment and patient satisfaction.

INTRODUCTION: Male pattern hair loss is widespread around the world. Its prevalence indicates the importance of finding the best treatment modalities. This study evaluates the efficacy and safety of minoxidil 5% topical foam in male pattern hair loss treatment and patient satisfaction. METHODS: This study was a before-and-after trial on 17 male patients with male pattern hair loss. Subjects were instructed to apply one capful (1 ml) of minoxidil 5% topical foam on the scalp daily for 6 months. Efficacy was assessed through hair counts, subject assessment, and global photographic review. RESULTS: Seventeen male volunteers were recruited, and three volunteers were withdrawn; 14 participated in the trial for 16 weeks, and 12 continued up to 24 weeks. The average hair count with a camera at week 16 (181.87 ± 52.42) and week 24 (194.58 ± 62.82) and with an eye count at week 16 (62.57 ± 15.28) and week 24 (69.91 ± 15.61) increased significantly compared to the baseline after intervention. CONCLUSIONS: This study confirmed that minoxidil 5% topical foam is a safe and effective treatment for MPHL. The effect of it is evident after 24 weeks of use.

A randomized clinical trial of efficacy and safety of the topical clonidine and capsaicin in the treatment of painful diabetic neuropathy.

BACKGROUND: Incomplete efficiency of oral medications restricts their therapeutic success in pain control of the painful form of the diabetic peripheral neuropathy (DPN). Use of topical medications because of less systemic side effects is more acceptable. This study aimed to compare the effect of clonidine gel and capsaicin cream in relieving pain associated with DPN. MATERIALS AND METHODS: This 12-week, randomized, double-blind and parallel-group trial was conducted to compare the efficacy and safety of topical clonidine and capsaicin. Totally, 139 patients with type 2 diabetes with a pain score of at least 4 as assessed by visual analog scale (VAS), were treated for up to 3 months. The endpoint of the study was the reduction in the median pain score from baseline, as assessed by the VAS at the 4 weekly follow-up visits. RESULTS: The intention-to-treat population for the efficacy analysis consists of 69 patients receiving clonidine and 70 patients receiving capsaicin. Both drugs significantly relieved pain at 12 weeks (P < 0.001 for both) but no significant difference in the efficacy between the two treatments was observed (P = 0.931). Dermatologic complications were more common in capsaicin group (P = 0.001). CONCLUSION: The results of this study showed the comparable efficacy of clonidine gel in comparison with capsaicin cream in the treatment of pain due to DPN with less adverse events. More studies are required to better evaluate the efficacy and safety of this topical compound for relieving pain in DPN.

A peptide carrier for the delivery of elastin into fibroblast cells.

BACKGROUND: Transmembrane delivery of active peptides and proteins, including skin delivery of cosmeceutical proteins such as collagen and elastin, has been a challenging issue. Amphipathic cell-penetrating peptides (CPPs) have been proposed as carrier peptides to mediate cellular uptake of proteins without covalent binding. MATERIALS AND METHODS: In this study, we have used a short peptide, Pep-1, as our CPP to transport elastin into fibroblast cells. Different ratios of Pep-1/elastin complexes were produced by using a fixed amount of elastin and different molar ratio of Pep-1. The ability of transduction into cells was determined by fluorescence microscopy. The characteristics of Pep-1/elastin complexes were monitored using scanning electron microscopy and photon correlation spectroscopy. RESULTS: No cellular toxicity was observed in cells treated with Pep-1/elastin complex. Finally, we determined a Pep-1 : elastin ratio of 10 : 1 as the most effective ratio in cellular delivery of elastin. CONCLUSION: Pep-1 mediated fast and effective delivery of elastin as a cosmetic protein into fibroblast cells in the treatment of skin-aging symptoms.