Waterpipe smoking is associated with presence and severity of coronary artery disease: a propensity score-matched study.

BACKGROUND: The prevalence of waterpipe smoking (WPS) has been increasing worldwide. This trend is alarming as WPS can negatively impact cardiovascular health. In the present study, we explored the association between WPS and the presence and severity of CAD. METHODS: This study was a retrospective analysis of patients who underwent diagnostic coronary angiography at Tehran Heart Center between April 2021 and May 2022. Patients with a previous history of percutaneous coronary intervention and coronary surgery were excluded. Waterpipe smokers were matched with non-smokers based on age, gender, and cigarette smoking using a 1:4 propensity score matching model. Stenosis ≥ 50% in any coronary artery was considered a CAD diagnosis. Gensini score was also calculated to measure the severity of the CAD. RESULTS: We reviewed the medical records of 8699 patients, including 380 waterpipe smokers. After matching, 1520 non-smokers with similar propensity scores to the waterpipe smokers were selected. Waterpipe smokers were more likely to have CAD than non-smokers (OR: 1.29; 95% CI: 1.04-1.60, P = 0.021). In addition, WPS increased the natural logarithm of the Gensini score by 1.24 (95% CI: 1.04-1.48, P = 0.014) in patients with atherosclerotic coronary disease. CONCLUSION: WPS may increase the risk of CAD independent of age, gender, and cigarette smoking. In addition, among patients with any degree of atherosclerosis in coronary arteries (GS > 0), WPS may lead to higher average GS, suggesting more severe atherosclerosis.

Brain MRI and EEG overemployment in patients with vasovagal syncope: results from a tertiary syncope unit.

BACKGROUND: The diagnosis of vasovagal syncope (VVS) is mainly based on history-taking and physical examination. However, brain Magnetic Resonance Imaging (MRI) and Electroencephalogram (EEG) are commonly used in the diagnostic course of VVS, despite not being indicated in the guidelines. This study aims to find the possible associated factors with the administration of brain MRI and EEG in patients with VVS. METHODS: Patients with a diagnosis of VVS from 2017 to 2022 were included. Several demographic and syncope features were recorded. The association of these was assessed with undergoing MRI, EEG, and either MRI or EEG. Univariate and multivariable logistic regression models were also used to calculate odds ratios (OR) and 95% confidence intervals (CI). RESULTS: A total of 1882 patients with VVS were analyzed, among which 810 underwent MRI (43.04%), 985 underwent EEG (52.34%), and 1166 underwent MRI or EEG (61.96%). Head trauma (OR 1.38, 95% CI 1.06 to 1.80), previous neurologist visit (OR 6.28, 95% CI 4.24 to 9.64), and gaze disturbance during syncope (OR 1.75, 95% CI 1.13 to 2.78) were all positively associated to the performance of brain MRI/EEG. Similar results were found for urinary incontinence (OR 2.415, 95% CI 1.494 to 4.055), amnesia (OR 1.421, 95% CI 1.053 to 1.930), headache after syncope (OR 1.321, 95% CI 1.046 to 1.672), and tonic-clonic movements in head-up tilt table test (OR 1.501, 95% CI 1.087 to 2.093). However, male sex (OR 0.655, 95% CI 0.535 to 0.800) and chest pain before syncope (OR 0.628, 95% CI 0.459 to 0.860) had significant negative associations with performing brain MRI/EEG. CONCLUSION: Based on our findings, performing MRI or EEG was common among VVS patients while it is not indicated in the majority of cases. This should be taken into consideration to prevent inappropriate MRI/EEG when there is a typical history compatible with VVS.

Left atrial function evaluation by 2D speckle-tracking echocardiography in patients with vasovagal syncope.

OBJECTIVES: Evidence indicates left atrial (LA) involvement in vasovagal syncope (VVS). The LA regulates left ventricular filling during the cardiac cycle. We aimed to assess LA function in patients with VVS by 2D speckle-tracking echocardiography. METHODS: Sixty-nine consecutive patients with VVS were recruited. Based on the head-up tilt test (HUTT) results, the study population was divided into two groups: HUTT+ (n = 45) and HUTT- (n = 24). Fifty-one consecutive subjects were enrolled as the control group. LA myocardial deformation parameters were measured by 2D speckle-tracking echocardiography to evaluate LA function. RESULTS: Maximal, minimal, and pre-P LA volumes were lower in patients with VVS. Strain and strain rate during reservoir, conduit, and contraction phases in VVS patients with HUTT+ or HUTT- were not statistically significantly different from those in the control group. Additionally, the volumetric parameters of LA function showed no difference in statistical significance between the three study groups. CONCLUSIONS: While LA phasic function was not different between the two groups of VVS patients with HUTT+ or HUTT- and the control group, LA size during the three LA phases was smaller in patients with VVS.

Compression stockings for treating vasovagal syncope (COMFORTS-II) trial: Rationale and design of a triple-blind, multi-center, randomized controlled trial.

BACKGROUND: Reduced venous return is an important trigger of vasovagal syncope (VVS). Elastic compression stockings (ECS) can modify venous return and be of therapeutic interest; however, evidence for ECS efficacy in VVS is scarce. This randomized controlled trial was designed to address the issue. METHODS: COMFORTS-II is a multicenter, triple-blind, parallel design, randomized controlled trial aimed to assess the efficacy of ECS in preventing VVS recurrences. Using central online randomization, 268 participants will be allocated to 2 arms (1:1 ratio), wearing intervention ECS (25-30 mm Hg pressure) or sham ECS (≤10 mm Hg pressure). All participants will receive standard VVS treatment in the form of education, and lifestyle modification recommendations (drinking 2-3 l/d of fluids and consuming 10 g/d-roughly half a tablespoon-of table salt). Adherence to ECS treatment will be evaluated through diary sheets, and compared between study arms. Follow-up continues for 1 year, and is conducted via a 24/7 phone line available to patients and trimonthly visits. The co-primary outcomes are proportion of participants with any syncopal recurrence and time to first syncopal episode. Secondary outcomes include frequency of VVS spells, time intervals between recurrences, and incidence of any patient-reported adverse effects. CONCLUSION: To the best of our knowledge, COMFORTS-II is the first clinical trial to assess ECS efficacy among patients with VVS, addressing an important gap in evidence for VVS treatments.

Implementation of supervised physical training to reduce vasovagal syncope recurrence: A randomized controlled trial.

INTRODUCTION: Physical techniques used for the prevention of vasovagal syncope have limited evidence for efficacy. We aimed to evaluate multimodal supervised physical training as a treatment approach. METHODS: In this 1:1 randomized trial, patients with ≥2 episodes of clinically diagnosed vasovagal syncope were included. On top of standard care, the intervention arm performed supervised tilt training and aerobic exercise in six sessions at a cardiac rehabilitation center (three sessions during the first month, and then at 3-month intervals), plus home tilt training. The control arm received standard care with a similar protocol of home tilt training. The primary outcome was time to first syncopal recurrence during 1 year of follow-up. RESULTS: Fifty participants were randomized (mean age: 34.5 ± 14.8 years; 64% female). The rate of syncopal recurrence was 28% and 64% within the intervention and control arms, respectively, with significantly higher syncope-free survival at 1 year in the intervention arm (Log-rank p = .003). The frequency of recurrent syncopal events was significantly lower with physical training (p = .017). Participants in the intervention arm reported significantly higher adherence to the home tilt training program (80% vs. 52%; p = .037). CONCLUSION: Among patients with recurrent vasovagal syncope, a supervised program of tilt training and aerobic exercise reduced syncopal recurrence. Future trials are warranted to further investigate multimodal supervised physical techniques as a therapeutic approach in treating vasovagal syncope.

Biophysical and ultrasonographic changes of acute Old World cutaneous leishmaniasis skin lesions in comparison with uninvolved skin: A possible tool for non-invasive early detection and treatment outcome assessment.

Cutaneous leishmaniasis (CL) is a skin disease caused by intracellular protozoa, which is endemic in Iran. The goal of this study was to compare biophysical characteristics in CL lesions with uninvolved skin. Stratum corneum hydration, transepidermal water loss, surface friction, pH, sebum, melanin, erythema, temperature, elasticity parameters (R0, R2, and R5), thickness and echo-density of epidermis and dermis were measured on the active erythematous indurated part of a typical CL lesion in 20 patients, and compared with the same location on the other side of the body as control. Paired t-test was used for statistical analyses and a p < 0.05 was considered significant. Melanin content, R2 and echo-density of dermis were significantly lower, whereas transepidermal water loss, friction index, pH, erythema index, temperature, and the thickness of dermis were significantly higher in CL lesions. There was no significant difference in stratum corneum hydration, sebum, R0, R5, thickness of epidermis, and density of epidermis between CL and normal skin. CL lesions are characterized by certain changes in biophysical and ultrasonographic properties, which are mostly correlated with histological features. These changes are likely to be useful in the non-invasive early detection of CL and also as treatment outcome measures for clinical trials of new treatment modalities for CL in the future.

Comparison of efficacy and safety of a novel 755-nm diode laser with conventional 755-nm alexandrite laser in reduction of axillary hairs.

The aim of this study was to compare the efficacy and safety of a novel diode system emitting 755 nm wavelength with conventional 755 nm alexandrite laser in skin types III and IV. It was a randomized, right-left comparison, assessor-blind, clinical study. Sixteen female volunteers age 29.52 ± 9.52 were randomly assigned to receive six treatment sessions using 755 nm diode laser on one axilla and 755 nm alexandrite on the opposite axilla. Efficacy was assessed by counting of hairs per square centimeter, 6 months after the last treatment. Treatment outcome was also evaluated by blind reviewing of before and after pictures, using Physician Global Assessment scale (GAS). Subject satisfaction was assessed using visual analogue scale (VAS), pain level and adverse effects were recorded. Skin biophysical parameters (transepidermal water loss, skin sebum, and erythema index) were also measured. Significant reduction in hair count was observed, 6 months after the last treatment session, for both devices (- 33% for 755 nm diode and - 35% for 755 nm alexandrite; p value = 0.85). The mean GAS score was 2.66 for alexandrite treated side vs. 2.00 for diode treated side (p value = 0.036). No severe adverse events were reported. The subject satisfaction score was significantly higher after treatment with alexandrite laser. No significant changes were detected in none of skin biophysical parameters. 755 nm diode laser is suitable for hair removal procedures and it is as effective and safe as the 755 nm alexandrite laser in skin types III-IV.

Predictive modeling for acute kidney injury after percutaneous coronary intervention in patients with acute coronary syndrome: a machine learning approach.

BACKGROUND: Acute kidney injury (AKI) is one of the preventable complications of percutaneous coronary intervention (PCI). This study aimed to develop machine learning (ML) models to predict AKI after PCI in patients with acute coronary syndrome (ACS). METHODS: This study was conducted at Tehran Heart Center from 2015 to 2020. Several variables were used to design five ML models: Naïve Bayes (NB), Logistic Regression (LR), CatBoost (CB), Multi-layer Perception (MLP), and Random Forest (RF). Feature importance was evaluated with the RF model, CB model, and LR coefficients while SHAP beeswarm plots based on the CB model were also used for deriving the importance of variables in the population using pre-procedural variables and all variables. Sensitivity, specificity, and the area under the receiver operating characteristics curve (ROC-AUC) were used as the evaluation measures. RESULTS: A total of 4592 patients were included, and 646 (14.1%) experienced AKI. The train data consisted of 3672 and the test data included 920 cases. The patient population had a mean age of 65.6 ± 11.2 years and 73.1% male predominance. Notably, left ventricular ejection fraction (LVEF) and fasting plasma glucose (FPG) had the highest feature importance when training the RF model on only pre-procedural features. SHAP plots for all features demonstrated LVEF and age as the top features. With pre-procedural variables only, CB had the highest AUC for the prediction of AKI (AUC 0.755, 95% CI 0.713 to 0.797), while RF had the highest sensitivity (75.9%) and MLP had the highest specificity (64.35%). However, when considering pre-procedural, procedural, and post-procedural features, RF outperformed other models (AUC: 0.775). In this analysis, CB achieved the highest sensitivity (82.95%) and NB had the highest specificity (82.93%). CONCLUSION: Our analyses showed that ML models can predict AKI with acceptable performance. This has potential clinical utility for assessing the individualized risk of AKI in ACS patients undergoing PCI. Additionally, the identified features in the models may aid in mitigating these risk factors.

Clinical Associations of Injuries Caused by Vasovagal Syncope: A Cohort Study From a Tertiary Syncope Unit.

Background Recent research has revealed that vasovagal syncope (VVS) leads to a high incidence of injuries; however, clinical associations of injury are not well-established. We present data from an ongoing VVS cohort and aimed to determine characteristics associated with VVS-related injury. Methods and Results Between 2017 and 2020, consecutive patients ≥18 years of age presenting to a tertiary syncope unit and diagnosed with VVS were included. Clinical characteristics relevant to syncope were obtained for the index episode. The outcome was incidence of injury during VVS, documented by clinical evaluation at the syncope clinic. Among 1115 patients (mean age, 45.9 years; 48% women), 260 injuries (23%) occurred. History of VVS-related injuries (adjusted relative risk [aRR], 1.80 [95% CI, 1.42-2.29]), standing position (aRR, 1.34 [95% CI, 1.06-1.68]), and female sex (aRR, 1.30 [95% CI, 1.06-1.60]) were associated with injury, whereas recurrent VVS (aRR, 0.63 [95% CI, 0.49-0.81]) and syncope in the noon/afternoon (aRR, 0.70 [95% CI, 0.56-0.87]) and evening/night (aRR, 0.43 [95% CI, 0.33-0.57]) compared with morning hours were associated with lower risk. There was a trend for higher rates of injury with overweight/obesity (aRR, 1.23 [95% CI, 0.99-1.54]) and syncope occurring at home (aRR, 1.22 [95% CI, 0.98-1.51]). In a per-syncope analysis considering up to 3 previous episodes (n=2518, 36% traumatic), syncope at home (aRR, 1.33 [95% CI, 1.17-1.51]) and absence of prodromes (aRR, 1.34 [95% CI, 1.09-1.61]) were associated with injury. Conclusions Patient characteristics, VVS presentations, the circumstances, and surroundings can determine the risk of injury. These associations of VVS-related injury identify at-risk individuals and high-risk situations. Future prospective studies are needed to investigate potential strategies for prevention of post-VVS injury in recurrent cases.

Predictors and mortality of patients with delayed pulmonary embolism diagnosis: A cohort study.

Background: Some earlier studies demonstrated an increased mortality risk attributed to delayed pulmonary embolism (PE) diagnosis. Therefore, we mainly aimed to determine the predictors of diagnostic delays and the effect of delayed diagnosis on mortality. Methods: We prospectively studied 756 consecutive patients admitted with PE between March 2007 and September 2017. The delayed diagnosis was defined as (1) patient presenting > 7 days after onset of symptoms, (2) diagnosis takes > 24 hours upon arriving in the ED, or (3) undergoing coronary angiography before establishing PE diagnosis. Results: A total of 127 (16.7%) patients met the delayed group's criteria. Heart failure (OR= 2.257, 95% CI: 1.130-4.508, P= 0.021), diabetes mellitus (OR= 1.568, 95% CI: 0.996-2.469, P= 0.052), and precordial T wave inversions (OR=2.559, 95% CI: 1.649-3.970, P< 0.001) were linked to higher rates of delayed diagnosis, while hemoptysis (OR=0.254, 95% CI: 0.059-1.087, P= 0.065) and hemodynamic instability (OR= 0.434, 95% CI: 0.168-1.123, P= 0.085) negatively correlated with it. Delayed PE diagnosis did not significantly impact the overall survival during the follow-up. The unadjusted and adjusted mortality hazard ratio for delayed diagnosis were 1.198 (95% CI: 0.758- 1.894, P= 0.439) and 1.215 (95% CI: 0.762- 1.939, P=0.413), respectively. Older age, heart failure, and hemodynamic instability increased the risk of death (p<0.001). Conclusion: Hemoptysis, hemodynamic instability, diabetes mellitus, heart failure, and T wave inversions in precordial leads were the independent predictors of delayed diagnosis. Delayed PE diagnosis did not increase the patients' mortality rates.

Right-sided Electrocardiogram in Patients With Acute Pulmonary Embolism.

BACKGROUND: Acute pulmonary embolism (APE) is an emergent condition. The diagnostic tools are CT angiography and echocardiography. However, all of these modalities can be used under stable and nonemergent conditions. As electrocardiographic (ECG) studies are more feasible under emergent situations, Objective: we aimed to study right-sided ECG (RS-ECG) in patients with APE with further analysis regarding echocardiographic findings and pulmonary embolism severity index (PESI). METHODS: Right-sided and standard electrocardiogram were obtained from 143 patients with confirmed APE. T-wave inversion, ST segment elevation (STE), and QS pattern in RS-ECG have been considered as abnormal changes. RESULTS: T-wave inversion, STE, and QS pattern were found in 78.3%, 42%, and 39.9% of patients, respectively. 88.1% of patients showed at least one of these abnormalities in their RS-ECGs. Sensitivity of RS-ECG for APE was 0.88, which was higher than sensitivity of standard ECG (0.79). Patients with STE in right precordial leads, had increased right to left ventricular (RV/LV) diameter ratio (P = 0.021) and had higher PESI score (P = 0.000). Moreover, STE in RS-ECG was an independent predictor for PESI score in patients with moderate (odds ratio 4.05; 95% confidence interval [CI], 1.37-11.96; P < 0.05) and high 30-day mortality risk (odds ratio 8.42; 95% CI, 2.08-33.93; P < 0.05). CONCLUSIONS: Abnormal changes in RS-ECG were associated with an increase in RV/LV diameter ratio and higher PESI score, which may be indicated poor prognosis in patients with APE. The most clinically useful ECG finding was STE which was associated with increased RV/LV diameter ratio and PESI score.

Clinical Features and Prognoses of Middle-Aged Women With ST-Elevation Myocardial Infarction With a Focus on Spontaneous Coronary Artery Dissection.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) has become an increasingly recognized cause of acute coronary syndrome, particularly in young women, over the last decade. The goal of this study was to determine the prognoses and characteristics of adult women with SCAD who presented with ST-elevation myocardial infarction (STEMI). METHODS: This retrospective cohort study enrolled all adult women under the age of 60 who had undergone coronary artery angiography in the setting of STEMI. The patients were divided into 3 groups based on their angiographic characteristics: STEMI-SCAD (STEMI due to SCAD), STEMI-ATH (STEMI caused by an atherosclerotic lesion), and STEMI-others (STEMI due to other etiologies including Takotsubo cardiomyopathy and myopericarditis, as well as STEMI despite a normal epicardial coronary angiography). RESULTS: Fifteen women out of 311 female patients aged below 60 years with STEMI were diagnosed with SCAD (4.8%). There were no significant differences in body mass index, hypertension, dyslipidemia, smoking status, opium addiction status, family history, previous percutaneous coronary intervention, coronary artery bypass grafting, and cerebrovascular accidents between the STEMI-SCAD and STEMI-ATH groups. Nevertheless, the STEMI-SCAD and STEMI-others groups were more likely to be younger, less likely to be diabetic, and less likely to have 3 cardiovascular risk factors or more than was the STEMI-ATH group. The left anterior descending artery was the most common culprit lesion in the STEMI-SCAD group (80%) and the other 2 groups. Out of the 311 patients, 7 patients died during the index hospitalization: 1 patient in the STEMI-SCAD group, 6 patients in the STEMI-ATH group, and 0 patients in the STEMI-others group. None of the patients in the STEMI-others group experienced any major adverse cardiac events during the follow-up. In the other 2 groups, the most experienced outcomes were myocardial infarction and in-hospital cardiac death, followed by target lesion revascularization and target vessel revascularization. CONCLUSIONS: STEMI-SCAD is one of the known causes of STEMI in young women. Still, despite the complexity of revascularization in our patients with STEMI-SCAD, they had more favorable prognoses in both conservative and revascularization management modalities than our patients with STEMI-ATH.

Skin biophysical assessments of four types of soaps by forearm in-use test.

BACKGROUND: While soaps are the most commonly used cleansing agents for human skin, they also damage the epidermal barrier and potentially increase the risk of disorders such as contact dermatitis. AIMS: This study set out to compare the potential skin irritancy of four types of soaps and their effects on the skin barrier function and biophysical parameters. METHODS: In a nonblinded comparative study, three types of soaps (alkaline, creamy, and glycerin soaps), and a syndet were applied to four different groups of 15 healthy subjects. Subjects washed their left forearm with the respective soap at home at least four times a day for seven days. Biophysical skin parameters, including transepidermal water loss (TEWL), erythema, friction, and pH, were measured at various time points using the Cutometer® MPA 580. RESULTS: After the first wash, a significant increase in TEWL was observed for all groups compared to the pre-intervention period. For the alkaline soap, a substantial increase in pH was observed at all time points compared to the baseline. Syndet, the only acidic soap in this study, showed a significant decrease in pH at the last time compared to all time points. The mean value of erythema was significantly higher in alkaline soap users than glycerin and creamy soap users. CONCLUSION: Our study showed that alkaline-based soaps could cause erythema and increase TEWL and skin pH due to their strong cleansing action, and the addition of compounds such as glycerin can modify these effects. A newer generation of soap containing a mild surfactant such as syndets causes less skin damage.

Atomoxetine as an adjunct to nonpharmacological treatments for preventing vasovagal attacks in patients with recurrent vasovagal syncope: A pilot randomized-controlled trial.

BACKGROUND: Despite the reduced quality of life in patients with recurrent vasovagal syncope (VVS), pharmacologic treatment options remain limited. Studies indicate that norepinephrine reuptake inhibition reduces tilt-induced syncope/pre-syncope. This study aimed to evaluate the effects of atomoxetine on syncopal/pre-syncopal episodes in patients with recurrent VVS. METHODS: In a placebo-controlled trial, we randomized patients with newly diagnosed VVS who experienced ≥3 syncopal episodes in the past three months to receive either atomoxetine (20 mg daily for two weeks followed by 40 mg daily for two weeks) or placebo. The primary endpoint was the combined number of syncopal and pre-syncopal episodes. RESULTS: Among 843 patients initially screened, 46 were randomized (N = 23 in each group) and reevaluated at one and three months. Compared to placebo, atomoxetine significantly reduced the primary endpoint after three months (P < 0.001). In the atomoxetine arm, the median time to first pre-syncopal episode was 55 days (95% confidence interval (CI): 41.21-68.79), while this was 27 days (95% CI: 14.48-39.52) for the placebo group (P < 0.001). In a subgroup analysis of patients with systolic blood pressure < 110 mmHg, atomoxetine reduced the primary endpoint, and the number of syncopal and pre-syncopal episodes after one and three months. In this subgroup, the median time to first pre-syncopal attack was 56 days in the atomoxetine group as opposed to 9 days in the placebo group. CONCLUSIONS: In this pilot study, the promising effects of atomoxetine in reducing syncopal/pre-syncopal episodes in recurrent VVS, especially with low blood pressure phenotype, warrant the conduction of future randomized trials.

Preparation and Safety Evaluation of Topical Simvastatin Loaded NLCs for Vitiligo.

Purpose: Vitiligo is a long-term common autoimmune disease in which growing patches of skin lose their color. There is no FDA-approved treatment for vitiligo. However, recent studies have demonstrated an immunosuppressive effect on vitiligo lesions in mouse models by simvastatin. A topical formulation was prepared containing simvastatin-loaded nano lipid carriers (simNLCs) for vitiligo treatment followed by evaluating their physicochemical characteristics and clinical safety. Methods: Both the lipid phase and the aqueous phase were heated to 75°C separately, and then simvastatin was dispersed in the lipid phase added to the aqueous phase. The mixture was homogenized for 1 minute, then for Nanostructured Lipid Carriers (NLC) formation, the emulsion was sonicated using a probe sonicator. The simNLCs produced were evaluated for drug entrapment, particle size and morphology, zeta potential, polydispersity index, viscosity, drug content, in vitro drug release, in vivo skin safety test, and long-term stability studies. Results: Dynamic light scattering, transmission electron microscopy and differential scanning calorimetry techniques proved the formation of a stable formulation containing spherical particles with nanoscale size. The drug entrapment efficiency and the drug-loading capacity were determined to be 99.27% and 3.9%, respectively. Human safety results indicated that adding simvastatin to lipid nanoparticles did not cause any changes to skin biophysical parameters. Conclusion: The preparation method of simNLC developed in this study is a suitable method, and the nanoparticles fabricated were safe with acceptable long-term stability and drug entrapment.

Evaluation of the safety and efficacy of a triple combination cream (hydroquinone, tretinoin, and fluocinolone) for treatment of melasma in Middle Eastern skin.

Background: Melasma is the most common pigmentary skin disorder, especially in females and those with darker complexion. The current study evaluated the safety and efficacy of a triple combination cream containing hydroquinone 4%+tretinoin 0.05%+fluocinolone acetonide 0.01% (Januluma® cream produced by Janus Pharmaceutical Co, Tehran, Iran) in the treatment of melasma. Patients and methods: Twenty-two female volunteers (mean±standard deviation of age: 39.20±4.16 years) who fulfilled the eligibility criteria participated in this study after signing the informed consent. They were requested to apply the Januluma®cream every night for 8 weeks. Modified melasma area and severity index (mMASI), skin lightness (L value), and severity of pigmentation (E value) by Visio Face, and skin biophysical parameters including pH, melanin index, erythema index, sebum, hydration, trans epidermal water loss, thickness and density of epidermis, and dermis (using 22 MHz ultrasonography) were measured before and 4 and 8 weeks after treatment. Also patients' satisfaction was assessed 4 and 8 weeks after treatment using visual analog score. Results: mMASI decreased significantly from 3.37 to 2.60 at week 4, and to 2.40 at week 8 (P-values=0.00 and 0.01, respectively). Also, E and L values improved significantly after 8 weeks of treatment (P=0.01 and 0.00, respectively). Skin melanin index decreased from 237.49 AU to 196.30 AU at week 8 (P=0.01). Also echo density of dermis increased significantly after 8 weeks of treatment (P=0.029). Almost all participants experienced some degrees of pruritus, scaling, and erythema, esspecially during the first month of application, which were generally mild and tolerable. The mean satisfaction of patients with the treatment was 6.77. Conclusion: The triple combination formula was reasonably safe and effective for treatment of melasma in Middle Eastern patients.

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.