Efficacy of Topical Botanical Treatment of Children With Mild to Moderate Atopic Dermatitis

Objective: The study was conducted to determine the efficacy of the botanical combination incorporated in Kamedis Eczema Therapy Cream (the test product) for children with mild to moderate atopic dermatitis. Design: The study was designed as an interventional, multi-center, double-blind, randomized, controlled study. Setting: Children subjects were a sub-population of the 108 combined population of adults and children evenly randomly divided into three treatment groups: test product, vehicle, and comparator. The vehicle used was the identical test product without the botanical combination while the comparator was a leading OTC brand in the US market. All three groups used the same Kamedis body wash followed by one of the three randomized treatment creams for the affected areas. Participants: Thirty-nine (39) children subjects with uncomplicated, stable, mild to moderate atopic dermatitis were recruited and qualified for the study, 24 female and 15 male, ages varying between 3 and 18. Measurements: Investigators assessed the severity of each subject using the Investigator Global Assessment (IGA), affected Body Surface Area (BSA) extent evaluated parameters at each of the visit days 0, 7, 14, and 28. Subjective symptoms of pruritus and insomnia were evaluated by the patient or their legal guardian. The SCORAD and EASI indexes were calculated based on the collected parameters. Results: The test product demonstrated an improvement in all evaluated and calculated clinical parameters over the vehicle at the end of the treatment duration, proving the validation that the test product is much more effective and beneficial than the vehicle. The test product reached 40% of 'clear' IGA subjects out of the enrolled subjects and 60% out of the 'clear' and 'almost clear' IGA subjects comparing to 8% and 38%, respectively, with the vehicle, presenting a clear advantage over the vehicle. The BSA improvement comparison analysis of the test product over the vehicle yielded P value of less than 0.05, which is statistically significant. The SCORAD and EASI indexes also showed an advantage of the test product versus the vehicle at week 4. Conclusion: The study results validate that the botanical combination is the key factor for the efficacy and improvement of the AD symptoms within this population of children. J Drugs Dermatol. 2019;18(10):1038-1045.

Validation of Botanical Treatment Efficiency for Adults and Children Suffering from Mild to Moderate Atopic Dermatitis

Objective: The study was conducted to determine the efficiency of the botanicals combination incorporated in the Kamedis Eczema Therapy Cream (the tested product) for adults and children suffering from mild to moderate Atopic Dermatitis. Design: The study designed as an interventional, multi-center, double-blind, randomized, controlled study. Setting: Subjects were evenly randomly divided into three treatment groups: tested product, vehicle, and comparator. The vehicle used was the identical tested product without the botanical combination while the comparator was a leading OTC brand in the US market. All three above groups used a similar Kamedis wash for the body and face following by one of the three randomized treatment creams for the affected areas on the face and body. Participants: One hundred and eight (108) subjects with uncomplicated, stable, mild to moderate atopic dermatitis recruited and qualified for the study; 71 females and 37 males, age 3 to 73. Measurements: The investigator assessed the severity of each subject using the Investigator Global Assessment (IGA) and affected body surface area (BSA) at each of the visit days 0, 7, 14, and 28. Results: The tested product demonstrated an improvement in IGA and BSA over the vehicle at every visit across treatment time, proving the validation that the botanical product is much more effective and beneficial than the same product without the botanicals. The tested product as well as the comparator reached exactly the same percentage, 34%, of 'clear' IGA subjects of the enrolled subjects, presenting advantage over the vehicle. The BSA improvement comparison analysis of the tested product over the vehicle yielded statistically significant P value of 0.0369. Conclusion: The study results approve and validate that the botanical combination is the key factor for the efficacy and improvement of the AD symptoms within this study population. J Drugs Dermatol. 2019;18(6):557-561.

A Randomized Controlled Study of a Novel Botanical Acne Spot Treatment.

OBJECTIVE: The study evaluated the tolerability and efficacy of a new presented treatment for acne. The product is an OTC topical gel consisting of 2% SA, which is also enriched in botanicals that have been shown to have anti-inflammatory properties.

DESIGN: The study was designed as a single-site, randomized, investigator-blinded, split-face 10-day study.

SETTING: Subjects enrolled with a minimum of 2 inflammatory papular acne lesions and 2 non-inflammatory open or closed comedones on both sides of the face in symmetrical locations, to the greatest degree possible. One side of each subject's face was randomly selected to receive the study treatment product.

PARTICIPANTS: 25 subjects, 15 female and 10 males, ages 12 to 43 years, suffering from mild to moderate acne.

Measurements: Study duration was 10 days, with study visits occurring at baseline (day 0), day 1, day 2, day 3, day 7, and day 10. Subjects underwent investigator facial evaluation and lesion assessment by dermatologist at each of the visit days. For the inflammatory lesions, the assessed parameters were erythema, elevation, induration, and overall impression. The assessed non-inflammatory parameters were elevation and overall impression.

Results: The observed difference between the treatment and the control group increased between day 1 and day 2 and reached an average of 15% to 20% with small varieties between the parameters and stayed similar across the remaining visits. Statistically significance (P less than 0.005) was achieved for all inflammatory and non-inflammatory tested parameters.

Conclusion: This study was performed to determine the safety, efficacy, and ease of use of a botanical acne treatment gel in providing a reduction in inflammatory acne lesion erythema, elevation, and induration. Erythema and elevation were the most influential parameters in inflammatory lesion with improvement noted after 2 days of application.

J Drugs Dermatol. 2017;16(6):599-603.

Sleep disordered breathing analysis in a general population using standard pulse oximeter signals.

OBJECTIVES: Obstructive sleep apnea reported as the apnea-hypopnea index (AHI) is usually measured in sleep laboratories using a high number of electrodes connected to the patient's body. In this study, we examined the use of a standard pulse oximeter system with an automated analysis based on the photoplethysmograph (PPG) signal for the diagnosis of sleep disordered breathing. Using a standard and simple device with high accuracy might provide a convenient diagnostic or screening solution for patient evaluation at home or in other out of center testing environments. METHODS: The study included 140 consecutive patients that were referred routinely to a sleep laboratory [SleepMed Inc.] for the diagnosis of sleep disordered breathing. Each patient underwent an overnight polysomnography (PSG) study according to AASM guidelines in an AASM-accredited sleep laboratory. The automatic analysis is based on photoplethysmographic and saturation signals only. Those two signals were recorded for the entire night as part of the full overnight PSG sleep study. The AHI calculated from the PPG analysis is compared to the AHI calculated from the manual scoring gold standard full PSG. RESULTS: The AHI and total respiratory events measured by the pulse oximeter analysis correlated very well with the corresponding results obtained by the gold standard full PSG. The sensitivity and specificity of AHI = or > 5 and 15 levels measured by the analysis are both above 90 %. The sensitivity and positive predictive value for the detection of respiratory event are both above 84 %. CONCLUSIONS: The tested system in this study yielded an acceptable result of sleep disordered breathing compared to the gold standard PSG in patients with moderate to severe sleep apnea. Accordingly and given the convenience and simplicity of the standard pulse oximeter device, the new system can be considered suitable for home and ambulatory diagnosis or screening of sleep disordered breathing patients.

Photoplethysmography as a single source for analysis of sleep-disordered breathing in patients with severe cardiovascular disease.

Sleep-disordered breathing and Cheyne-Stokes breathing are often not diagnosed, especially in cardiovascular patients. An automated system based on photoplethysmographic signals might provide a convenient screening and diagnostic solution for patient evaluation at home or in an ambulatory setting. We compared event detection and classification obtained by full polysomnography (the 'gold standard') and by an automated new algorithm system in 74 subjects. Each subject underwent overnight polysomnography, 60 in a hospital cardiology department and 14 while being tested for suspected sleep-disordered breathing in a sleep laboratory. The sleep-disordered breathing and Cheyne-Stokes breathing parameters measured by a new automated algorithm system correlated very well with the corresponding results obtained by full polysomnography. The sensitivity of the Cheyne-Stokes breathing detected from the system compared to full polysomnography was 92% [95% confidence interval (CI): 78.6-98.3%] and specificity 94% (95% CI: 81.3-99.3%). Comparison of the Apnea Hyponea Index with a cutoff level of 15 shows a sensitivity of 98% (95% CI: 87.1-99.6%) and specificity of 96% (95% CI: 79.8-99.3%). The detection of respiratory events showed agreement of approximately 80%. Regression and Bland-Altman plots revealed good agreement between the two methods. Relative to gold-standard polysomnography, the simply used automated system in this study yielded an acceptable analysis of sleep- and/or cardiac-related breathing disorders. Accordingly, and given the convenience and simplicity of its application, this system can be considered as a suitable platform for home and ambulatory screening and diagnosis of sleep-disordered breathing in patients with cardiovascular disease.

Long-term assessment of nocturnal Cheyne-Stokes respiration in patients with heart failure.

PURPOSE: Cheyne-Stokes respiration (CSR) is a known controversial prognostic marker in patients with heart failure (HF). Little is known, moreover, about the development and progress of CSR in such patients. The CSR progress over time may be indicative for clinical deterioration in patients with HF disease METHODS: Prospective cohort sleep studies, with algorithm-based analyses of continuously or periodically monitored changes over time using standard pulse oximeter. Home testing for 4 months of patients recruited from the cardiology department of a large community medical center in Haifa, Israel. A total of 36 patients, 31 men and five women, aged between 50 and 74 years, with symptomatic chronic HF. RESULTS: Out of the 36 patients, 15 (42%) patients were found to have CSR. The CSR cycle length was chosen as the characteristic parameter which determines the periodicity of the event and its length. Analyses of CSR cycle length and duration in the 15 patients showed changes over time in the length of the CSR event only in patient with New York Heart Association (NYHA) 4 classification. CONCLUSIONS: Nocturnal CSR in patients with HF show small variations over time in the prevalence or duration of the cycle length and could be a marker for entering stage 4 or deterioration in the NYHA class of HF patient. Moreover, it may take years for HF patients to develop CSR or to increase the length of the cycle length of existing CSR, if they develop it at all.

Scalp Seborrheic Dermatitis and Dandruff Therapy Using a Herbal and Zinc Pyrithione-based Therapy of Shampoo and Scalp Lotion.

Objective: The aim of this study was to evaluate the safety and efficacy of an herbal and zinc pyrithione shampoo and a scalp lotion (Kamedis Derma-Scalp Dandruff Therapy, Kamedis Ltd., Tel Aviv, Israel) for the treatment of scalp seborrheic dermatitis and dandruff. Design: This was an interventional, open-label, safety and efficacy study. Setting: This open-label study was conducted at Consumer Product Testing Company Inc. in Fairfield, New Jersey. At the baseline visit (Day 0), an examination of the scalp was conducted by a board-certified dermatologist. The entire scalp was evaluated for evidence of seborrheic dermatitis using the Adherent Scalp Flaking Score with a 10-point scale. Only subjects with evidence of moderate-to-greater seborrheic dermatitis or moderate-to-greater dandruff were deemed qualified for inclusion in the study. Participants: Fifty subjects were recruited and included in the study. Measurements: Study subjects were evaluated by the same dermatologist for erythema and flaking at Days 0, 14, 28, and 42 using a five-point scale for each parameter. At each time point, a total severity score was calculated based on the findings of the evaluations. Following the scalp evaluation, each subject had a standardized digital photograph taken of his or her scalp. Each subject was also asked to answer a satisfaction questionnaire regarding the product treatment enhancement and characteristics. Results: A reduction in both parameters evaluated was seen at all time points. Statistical significance was achieved at each time point when compared with the baseline visit. In addition, the subjects expressed a high degree of satisfaction with the treatment. No adverse events were reported during this study. Conclusion: The study showed that the herbal zinc pyrithione shampoo and scalp lotion provided improvement in the main symptoms of seborrheic dermatitis.

Treatment of Seborrheic Dermatitis Using a Novel Herbal-based Cream.

Objective: Seborrheic dermatitis is a common relapsing inflammatory skin condition occurring in approximately 3 to 5 percent of the general population. Current available therapies control, but do not cure seborrhea. The study's objective was to determine the safety and efficacy of a barrier-based, nonsteroidal cream incorporating herbal extracts as a treatment for facial seborrheic dermatitis. Design: Interventional, open label, safety/efficacy study. Setting: At the baseline visit, the investigator selected a target area on the face. The target area was evaluated for Investigator Static Global Assessment, desquamation (scaling), induration (inflammation), and erythema (redness) as well as self-assessed pruritus. Participants: Thirty-two subjects with seborrheic dermatitis were enrolled in the study. Measurements: Subjects were instructed to use the study medication twice a day, morning and evening, for a consecutive period of 42 days. In addition to the baseline visit (Day 0), subjects visited the clinic for two follow-up visits at Days 14 and 28 and for a final visit at Day 42. At each visit, all parameters were evaluated. Results: A reduction in all parameters evaluated was seen at almost all timepoints, improving more from one timepoint to the next during the study period. In addition, the patients expressed a high degree of satisfaction with the treatment. No adverse events were reported during this study. Conclusion: The study showed that after six weeks of treatment, the face cream provided improvement in Investigator Static Global Assessment, pruritus, desquamation, induration, and erythema. ClinicalTrials.gov Identifier: NCT02656368 (https://clinicaltrials.gov/ct2/sh ow/NCT02656368?term=Kamedis&rank=2).

Monitoring lung resistivity changes in congestive heart failure patients using the bioimpedance technique.

The feasibility of a novel, dedicated system for monitoring lung resistivity in congestive heart failure patients, implementing a hybrid approach of the bioimpedance technique, was assessed in this preliminary study. Thirty-three healthy volunteers and 34 congestive heart failure patients were measured with the PulmoTrace system (CardioInspect, Tel Aviv University, Tel Aviv, Israel) during tidal respiration, and the ability to monitor the respective lung resistivity values was assessed. Mean left and right lung resistivity values of 1205+/-163 and 1200+/-165 ohm.cm for the control group and 888+/-193 and 943+/-187 ohm.cm for the congestive heart failure group were found, indicating a significant (p<2.10(-7)) difference between the two groups. The results of long-term monitoring of two patients during medical treatment are also shown. This hybrid approach system is believed to improve diagnostic capabilities and help physicians to better adjust medication dosage on a frequent basis.

An automated sleep-analysis system operated through a standard hospital monitor.

STUDY OBJECTIVES: Sleep disordered breathing (SDB), a cause of clinically important cardiovascular comorbidity, is often not recognized and diagnosed. An automated system that detects SDB using signals from a standard hospital monitor might provide useful information about the presence and severity of SDB without the need to evaluate the patient in a sleep laboratory and without additional hardware. The aim of this study was to examine the feasibility and accuracy of routine overnight sleep testing for SDB detection by an automated analysis system that operates by analyzing signals derived from standard hospital monitors. METHODS: Comparison of SDB detection by simultaneous "gold-standard" polysomnography and by Morpheus Hx (WideMed, Ltd., Herzliya, Israel), a bedside computerized analysis system (CAS) connected to a standard hospital monitor (ECG, respiratory impedance, end-tidal carbon dioxide (ETCO2), and SpO2). A total of 53 subjects were examined, 36 men and 17 women, all with suspected SDB. Each subject underwent an overnight sleep study, scored both by polysomnography and by CAS. The study was conducted in Brigham and Women's Hospital, Newton Center, MA. RESULTS: CAS-derived values for apnea-hypopnea index and total sleep time, were each found to be highly correlated with the corresponding polysomnography results, with linear regression values of r = 0.96 and r = 0.82, respectively. Mean apnea-hypopnea index values were also quite similar (CAS of 15.5 +/- 20.0 vs polysomnography of 15.4 +/- 24.0). CONCLUSIONS: An automated sleep-analysis system utilizing signals derived from a standard hospital monitor can be considered as a feasible and accurate method to detect and quantify SDB.

A three-dimensional numerical fluid dynamic model of antigen-antibody surface adsorption on piezoelectric immunosensors.

A piezoelectric crystal is a unit that changes its frequency in parallel with a change in its mass. This characteristic is exploited in designing flow cell-based immunosensors for detecting the concentration of antibodies in liquid samples. In the present study, computational fluid dynamic techniques are used to optimize the antigen-antibody binding process on an electrode surface placed on the base of a conical flow cell. The geometry optimization of the flow cell was determined to minimize the test time. This time is needed for the electrode to be saturated by the antibody, a process that requires the maximization of the adsorption rate and be accomplished by increasing the shear rate in the vicinity of the electrode. To validate the numerical model and to determine its parameters, experiments were carried out using an identical flow cell. In the experiments, the system did not reach saturation within an acceptable time frame, therefore, the model parameters were determined based on the unsaturated state. The experimental results confirmed the applicability of numerical simulations in predicting the effect of changing the inlet section area of the flow cells, proving the computational model to be very valuable in designing immunosensors based on flow cells.