Gel In Patients Research Articles

Use of mechlorethamine gel in patients diagnosed with mycosis fungoides cutaneous T-cell lymphoma (MF-CTCL): “Real-world” experience from the Prospective Observational Study (PROVe)

Use of mechlorethamine gel in patients diagnosed with mycosis fungoides cutaneous T-cell lymphoma (MF-CTCL): “Real-world” experience from the Prospective Observational Study (PROVe)

Morbidity and mortality associated with the interaction of miconazole oral gel and warfarin

Oral candidiasis is a frequently encountered oral fungal infection which can be treated with systemic and topical antifungal agents. Warfarin is a widely used oral anticoagulant. The interaction of miconazole oral gel and warfarin, causing potentiation of anticoagulant activity, has been documented over many years with evidence of occurrence in multiple settings and is a significant patient safety risk. This dangerous interaction remains underappreciated by dentists, doctors, pharmacists and patients, with resulting significant morbidity and mortality still occurring. This paper reports on recent developments concerning this interaction, and the important patient safety issues involved. In situations where topical treatment for oral candidiasis is indicated, nystatin should be prescribed instead of miconazole oral gel in patients taking warfarin, unless close monitoring and titration of the anticoagulant effect is undertaken.

Показатели оптической плотности альвеолярной кости пациентов с хроническим генерализованным пародонтитом и бруксизмом

The article is devoted to the study of optical density of patients with paradentium diseases. The aim of the study was the evaluation of indicators of optical density of bone tissue of jaws using dental computerized tomography in patients with chronic generalized parodontitis. Materials and methods: in the research following methods were used: dental computerized tomography, densitometry, index estimation of paradentium tissues. The characteristics of clinical, functional features of patients were given. The method of treatment was developed. The effectiveness of this method was evaluated. The positive dynamics of clinical symptoms is more pronounced in patients that received the offered method of treatment, than in patients that received basic therapy. This revealed in the reduction of time of the treatment on 10 days in average. The disappearance of edema, hyperemia of the gingiva, pain and bleeding during the probing and during eating, the restoration of densely elastic consistency of the gingiva, correct configuration of marginal papillae and full gingival edge are clinically revealed. Complex use of basic therapy, laserphoresis with Kanalgat gel in patients with chronic generalized parodontitis of mild severity caused to significant increase in the clinical effectiveness of treatment.

Randomized, double‐blind, placebo‐controlled, interventional phase IV investigation to assess the efficacy and safety of r‐hirudin gel (1120I.U) in patients with hematomas

Unlabelled Box BackgroundHirudin is the most potent direct thrombin inhibitor, and recombinant forms are routinely used in anticoagulation therapy. Recombinant hirudin gels are commercially available for the treatment of hematomas and associated symptoms. ObjectivesTo assess the efficacy and safety of a topically administered recombinant hirudin gel in patients with hematomas. Patients/MethodsThis double‐blind, placebo‐controlled, phase IV investigation recruited patients presenting with at least one hematoma. Subjects were randomly assigned (1:1) recombinant hirudin gel (1120 IU/100 g) or a placebo, administered 2‐3 times daily for 16 days. Changes in hematoma size, flare, and the proportion of patients achieving complete resolution of hematomas and associated edemas were investigated. ResultsBy study end, a greater proportion of subjects in the treatment group achieved a complete resolution of hematomas versus placebo (98.0% vs 71.9%; P < .001) and edemas (99% vs 50%; P < .001). Patients in the recombinant hirudin group exhibited a marginally larger, yet significant, reduction in mean hematoma size versus placebo (99.9% vs 96.6%; P < .001) and flare (93.6% vs 78.6%; P < .001). Median time to hematoma resolution for the recombinant hirudin and placebo administered cohorts was 8 and 16 days, respectively (P < .001). No adverse events were reported for the recombinant hirudin cohort. ConclusionsTopical recombinant hirudin is an effective, safe, and well tolerated intervention for the symptomatic treatment of hematomas. This trial was registered at www.clinicaltrials.gov as NCT01960569.

Effect of a Monoshot Injection of a High-Density Hyaluronic Acid Gel in Patients with Primary Knee Osteoarthritis. Preliminary Results of the “No-Dolor” Study

Objective: Pronolis® HD Mono 2.5% (4.8 mL) is a sterile viscoelastic solution of Hyaluronic Acid (HA) that has been recently commercialized (medical device class III). It contains the highest concentration of HA (2.5%: 120 mg HA in 4.8 mL) and is currently available in Spain for intraarticular injection in the knee.The main objective of the study is to evaluate the evolution of pain in patients diagnosed with primary knee osteoarthritis treated with Pronolis® HD Mono 2.5% (4.8 mL). Methods: An observational, real-life, multicentric (60 specialized care centers), prospective, open study planned to include 300 patients diagnosed with primary knee osteoarthritis (according to ACR criteria, pain at inclusion equal or superior to 4 out of 10) in order to evaluate the pain evolution, measured by the Visual Analogue Scale (VAS).After a single dose of Pronolis® HD Mono 2.5% (4.8 mL), patients are followed for 6 months. Preliminary results are presented to observe the first trends of change, 3 months vs. basal:- In the pain domain score of the WOMAC-A questionnaire (main criteria). - In the score of the domain of joint stiffness, functional capacity and pain in movement (WOMAC-B and C and 1st question of WOMAC-A) (secondary criteria). - In the evolution of the quality of life measured by the international standardized health questionnaire EQ-5D-5L. The study is approved by the Ethics Committee for Clinical Research of the Hospital del Mar in Barcelona (CEIC-Parc de Salut Mar). Results: Currently, 3 months data of 14 patients is available out of the 24 patients included to date. The degree of pain assessed by the Western Ontario and McMaster Universities Arthritis Index (WOMAC-A) shows an average improvement in pain of 7.71 points (54.5%). In 11 (78.6%) of the 14 patients, the average degree of pain improvement is equal to or greater than 30%. The degree of stiffness in the joint, the functional capacity of the patient and the degree of pain in movement show an average improvement of 3.71 points (62.87%), of 30.64 points (58.08%) and of 1, 71 points (55.95%), respectively. Quality of life improves in the 5 dimensions of the EQ-5D-5L improvement of quality of life has measured 34.52% in mobility, 41.67% in personal care, 39.88% in daily activities, 45.83% in pain/discomfort and 61.90% in anxiety/depression. No patient has presented adverse reactions to the investigational product. Conclusion: After 3 months of the intra-articular injection of a mono-shot, high-density HA gel (Pronolis® HD Mono- Shot 2.5%) patients with primary knee osteoarthritis show an important tendency to improve pain, joint stiffness, functional capacity and quality of life. These preliminary results need to be confirmed upon study completion.

Effect of topical application red betel (piper crocatum) leaf gel on clinical attachment level repair patient with chronic periodontitis

Objective: The purpose of this study was to determine the effect of red betel (piper crocatum) leaf gel as adjunctive therapy of scaling and root planing to the clinical attachment level (CAL) repair in the treatment of chronic periodontitis.Material and Methods: This study is a randomized control trial, single-blind, split mouth method before and after treatment. 18 patients of chronic periodontitis, aged 30-62 years participated in the study. The study was conducted by dividing jaw of the subjects into 2 sides, test and control. Both sides were treated scaling and root planing, and the test side given additional topical application of red betel leaf gel. Evaluation of CAL was performed 1 month after treatment. The data were statistically analyzed using the paired t test for comparison before and after treatment on each side and the unpaired t test to compare the test and control side.Results: Improvement of CAL in the test side is better than the control side, while distobuccal test side showed the greatest improvement 31.4%.Conclusion: Topical application of red betel leaf gel in patients with chronic periodontitis can increase the clinical attachment level.

Efficacy of 1% Metformin Gel in Patients With Moderate and Severe Chronic Periodontitis: A Randomized Controlled Clinical Trial.

The aim of this study is to investigate efficacy of metformin (MF) 1% gel as an adjunct to scaling and root planing (SRP) in the treatment of moderate and severe chronic periodontitis (CP). Seventy patients were categorized into two treatment groups: 1) SRP plus 1% MF and 2) SRP plus placebo. Clinical parameters were recorded at baseline and 3, 6, and 9 months. They included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). Radiologic assessment of intrabony defects (IBDs) and percentage defect depth reduction (DDR%) was done at baseline and 6- and 9-month intervals using computer-aided software. PD, CAL, and DDR% were evaluated in two subgroups in both the placebo and MF group: 1) initial PD of 5 to 7 mm and 2) initial PD of >7 mm. Mean PD reduction and mean CAL gain was found to be greater in the MF group than the placebo group at all visits. Clinical parameters (PD, CAL) in both subgroups, with initial PDs of 5 to 7 and >7 mm, showed significant improvement in the 1% MF group compared with the placebo group. A significantly greater mean DDR% was found in the MF group than the placebo group at 6 and 9 months in both subgroups, 5 to 7 and >7 mm of initial PD. There was a greater decrease in PD and more CAL gain with significant IBD depth reduction at sites treated with SRP plus locally delivered MF in patients with CP in both initial PD = 5 to 7 and >7 mm subgroups compared with placebo.

The efficacy of chlorhexidine gel in the prevention of alveolar osteitis after mandibular third molar extraction: a systematic review and meta-analysis

BackgroundAlveolar osteitis is a very painful and distressing condition for a patient who has recently undergone a tooth extraction and has led dental professionals to search for preventive measures. The aim of this meta-analysis to determine the effect of chlorhexidine (CHX) gel on the incidence of alveolar osteitis after mandibular third molar extraction.MethodsStudies were searched for on electronic search engines using Medline (PubMed), Cochrane central, Scopus and advanced Google Scholar from May 2015 to December 2015. Randomized controlled trial studies with a history of mandibular third molar extraction, along with the administration of topical chlorhexidine gel were included. The risk of bias of the selected articles was assessed using the Cochrane risk of bias assessment tool. RevMan 5.3 Software was used to analyze the pooled effect. I2 was calculated to determine heterogeneity and a funnel plot was used to check the risk of bias. Subgroup analysis was also done based on the presence of confounding factors (smoking, oral contraceptive etc.) and on split mouth design.ResultsOut of 52 articles, ten met the inclusion criteria. 862 participants were involved in the selected studies with a mean age range from 24.15 ± 5.02 to 36.65 ± 11. The overall RR was 0.43 (95% CI: 0.32, 0.58, p < 0.00001). Three studies used a split-mouth design to check the effect of chlorhexidine gel in the prevention of alveolar osteitis incidence. There was a pooled effect of 0.29 (95% CI: 0.16, 0.50) for the intervention group in the split mouth design studies. A stratified analysis was done to check the effect of CHX gel in patients with confounding factors and a significant reduction of AO incidence was found; 0.60 (95% CI: 0.41, 0.87; p = 0.05) in the intervention. There was no reported adverse reaction. The heterogeneity (I2) was 40%. The funnel plot showed that there was no significant publication bias.ConclusionThis meta-analysis suggests that CHX gel is superior to a placebo in reducing the incidence of alveolar osteitis after mandibular third molar extraction.

Diagnosis of endometriotic lesions by sonovaginography with ultrasound gel.

The aim of the study was to evaluate the diagnostic ability of sonovaginography (SVG) with ultrasound gel inpatients with endometriosis. We conducted a multicentre prospective study, which included 193patients with symptoms highly suggestive for endometriosis. All patients were investigated by transvaginal sonography andSVG with gel and afterwards underwent laparoscopic surgery. For each category of endometriotic lesions investigated, wecalculated and compared the sensitivity, specificity, positive predictive value and negative predictive value of the imagisticinvestigations used. In the case of endometriotic lesions of the uterosacral ligaments, SVG with gel had a sensitivityof 78.5% and a specificity of 96% (p=ns). The lesions of the vagina and rectovaginal septum were diagnosed with a sensitivityof 79%, respectively 94% (p=ns), obtaining a specificity of 99%, respectively of 97% (p=0.007). The lesions of the Douglaspouch were identified with a sensitivity of 81% (p=0.015), and those of the rectosigmoid with a 94% sensitivity (p=0.010). Weobtained lower sensitivity (67%) in detecting the lesions of the urinary bladder (p=ns). SGV with ultrasound gelrepresents a useful investigation tool for the evaluation of endometriotic lesions in the posterior pelvic compartment.

Authors’ Reply to Lambarth: “Levodopa-Carbidopa Intestinal Gel in Patients with Parkinson’s Disease: A Systematic Review”

Authors' Reply to Lambarth : "Levodopa-Carbidopa Intestinal Gel in Patients with Parkinson's Disease: A Systematic Review"

A randomized, double-blind, placebo controlled safety, tolerability, and pharmacokinetic dose escalation study of a gentamicin vancomycin gel in patients undergoing colorectal surgery.

BackgroundDespite numerous interventions promulgated by the Surgical Care Improve Project (SCIP) and other organizations, surgical site infection (SSI) continues to be a significant medical problem. DFA-02 is a novel bioresorbable modified-release gel consisting of both gentamicin (16.8 mg/mL) and vancomycin (18.8 mg/mL) to be applied during surgical incision closure for the prevention of SSIs. The following double-blind phase 2a trial was designed to test the safety and tolerability of DFA-02.MethodsAt six US sites, the study planned to randomize 40 subjects undergoing colorectal surgery (30 with DFA-02, and eight with placebo gel) in four ascending dose cohorts (10-, 20-, 30-, and 40-mL study drug per wound). Safety was ascertained and serum pharmacokinetics (PK) was determined.ResultsStudy enrollment was discontinued after the first three dose cohorts (10, 20, and 30 mL) as even very large incisions could not accommodate more than 20 mL of gel, leaving no scientific justification for the 40-mL cohort. DFA-02 was well tolerated and showed no evidence of local tissue reaction or impairment of wound healing. No serious AEs were deemed related to study drug. Systemic exposure to gentamicin and vancomycin remained well below levels considered to be at higher risk for oto- or nephrotoxicity. The maximal gentamicin and vancomycin levels observed were 2.36 and 0.684 μg/mL at 6 h, which were well below the prespecified stopping criteria of 12 and 20 μg/mL, respectively.ConclusionsIn this small phase 2a study, the study drug was well tolerated and appeared to be free of serious adverse effects. Consistent with these findings, the PK values were consistent with gradual release of the antibiotics from the gel in the surgical site.Trial registrationClinicalTrials.gov, NCT01496352

Levodopa-Carbidopa Intestinal Gel in Patients with Parkinson's Disease: A Systematic Review.

Levodopa-carbidopa intestinal gel (LCIG) is available in several countries for the treatment of advanced levodopa-responsive Parkinson's disease (PD) with severe motor fluctuations and dyskinesia when other treatments have not given satisfactory results. Our objective was to summarize the present evidence base for LCIG therapy through a systematic review of the literature. Studies were identified from the PubMed and EMBASE databases up to 12 March 2016 using the following search terms: Parkinson disease, duodopa, levodopa/carbidopa intestinal gel, levodopa-carbidopa intestinal gel, LCIG, l-dopa infusion, levodopa infusion, duodenal l-dopa infusion, and duodenal levodopa infusion. Data extraction focused on whether LCIG therapy improves motor and non-motor outcomes as well as quality of life in PD patients compared with conventional therapy, apomorphine infusion, or deep brain stimulation. Randomized controlled trials (RCTs) and observational studies, with or without a control group, that included more than ten patients were included. The search was limited to peer-reviewed articles published in full in the English language and involving humans. Infusion of LCIG reduced "off" time, increased "on" time without increasing troublesome dyskinesias, and improved quality of life in three RCTs (one double-blind). Open-label follow-ups confirm these findings. The data evaluating long-term efficacy and safety are still limited. The quality of evidence that LCIG is effective in reducing fluctuating motor symptoms and improving quality of life is moderate. Quality of evidence for reduction of non-motor symptoms is very low. Safety issues mainly relate to the intestinal infusion system. LCIG might be a useful treatment option in PD patients with severe motor fluctuations.

Ketoprofen gel improves low back pain in addition to IV dexketoprofen: a randomized placebo-controlled trial

ObjectiveOligoanalgesia is common in emergency departments (EDs), and pain management is of concern for ED physicians. The aim of this study was to reveal the effect of ketoprofen gel in patients presenting with mechanical low back pain to the ED. MethodAll the study patients received intravenous dexketoprofen additional to study drugs. After dexketoprofen, 2 g of 2.5% ketoprofen gel or placebo was administered to the site with pain and tenderness. Pain relief at 15 and 30 minutes was measured by visual analog scale scores. Rescue drug need and adverse effects were also recorded. ResultsA total of 140 patients were enrolled into the study. The mean age of the study patients was 35±12, and 56% (n=79) of them were male. The mean pain reduction at 30 minutes was 52±18 for ketoprofen gel and 37±17 for placebo, and ketoprofen gel was better than placebo at 30 minutes (mean difference, 16 mm; 95% confidence interval, 10-21). Ten patients (14%) in the placebo group and 2 patients (3%) in the ketoprofen gel group needed rescue drug (P=.35). ConclusionKetoprofen gel improves pain in patients presenting with mechanical low back pain to ED at 30 minutes in addition to intravenous dexketoprofen when compared to placebo.

Improvement of health-related quality of life and adherence to treatment with calcipotriol-betamethasone dipropionate gel in patients with psoriasis vulgaris.

BACKGROUNDPsoriasis is a common, chronic, recurrent, immune-mediated disorder of the skin and joints. It can have a significant negative impact on the physical, emotional and psychosocial wellbeing of affected patients.OBJECTIVESTo measure improvement in health-related QoL (HRQoL) in Greek patients with psoriasis vulgaris after a month of treatment with calcipotriol-betamethasone dipropionate gel; and evaluate adherence to treatment parameters.METHODSThe study included 394 psoriasis vulgaris patients from 16 private dermatological practices in Greece, all treated with calcipotriol-betamethasone dipropionate gel. They were evaluated at the first visit and after 4 weeks. Moreover, they completed the Dermatology Life Quality Index (DLQI), while other data such as disease severity, subjective symptoms and adherence, were collected.RESULTSAt week 4, the DLQI median was reduced by 3.5 points from the baseline (p<0.001; baseline and week 4 median: 4.5 and 1.0 respectively). Pruritus and sleep disorders also improved (p<0.001). Furthermore, 90.1% of the subjects fully adhered to treatment, with a 97.1% mean level of compliance.CONCLUSIONSThe convincing clinical results, with a distinct improvement in HRQoL, plus the high level of adherence due to its advantageous physical properties, make the calcipotriol-betamethasone dipropionate gel formulation an important, effective and well-tolerated topical therapy to treat psoriasis.

Adjunctive Local Delivery of Aloe Vera Gel in Patients With Type 2 Diabetes and Chronic Periodontitis: A Randomized, Controlled Clinical Trial

Herbal agents such as Aloe vera (AV) have been used in medical and dental therapy for thousands of years. AV has anti-inflammatory, antioxidant, antimicrobial, hypoglycemic, healing-promoting, and immune-boosting properties. This study aims to investigate the clinical effectiveness of locally delivered AV gel used as an adjunct to scaling and root planing (SRP) in the treatment of patients with type 2 diabetes mellitus (T2DM) and chronic periodontitis (CP). Sixty patients with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 3 mm were randomly divided into two groups. All patients underwent SRP. Placebo gel was locally delivered to group 1 and AV gel to group 2. Full-mouth plaque index (PI), modified sulcus bleeding index (mSBI), PD, and CAL were recorded at baseline and 3 and 6 months. Patients in group 2 showed significantly greater mean reductions in PI, mSBI, and PD and mean gain in CAL compared with those in group 1 from baseline to 3 months. Gain in CAL was significantly greater in group 2 at all time intervals versus group 1. Adjunctive use of locally delivered AV gel, in comparison to locally delivered placebo gel, is associated with greater reduction in PI, mSBI, and PD as well as more gain in CAL in patients with T2DM and CP.

The Effectiveness of Benzoyl Peroxide 5% Gel with 0.05% Tretinoin Gel in Patients with Mild Acne Vulgaris (Identification of P. Acnes)

Topical tretinoin is used by the dermatolovenereologist and aesthetic physicians in patients with mild acne vulgaris, so it is necessary to be investigated. The aim of the study was to assess the effectiveness of benzoyl peroxide gel compared to tretinoin gel on persons with mild acne vulgaris and identify Propionibacterium acnes in patients with mild acne vulgaris. The research method was a clinical trial, double blind randomization. Patients with mild acne vulgaris were randomized in to 2 groups, each group was examined for clinical manifestations (comedone, papules or pustules) examination with sebumeter 815 and Polymerase Chain Reaction, every night each group was treated with benzoyl peroxide 5% gel and tretinoin 0.05% gel in the application, and followed-up in the days of the week 2, 4 and 6. Data were processed with Mann-Whitney test and Chi-Square Test. The results indicated benzoyl peroxide 5% gel and tretinoin 0.05% gel have the same effectiveness in patients with mild acne vulgaris. But, benzoyl peroxide 5% gel decreased blackheads faster compared to papules or pustules with 0.05% tretinoin gel. of sebum. There was no difference in levels of decrease between benzoyl peroxide 5% gel and tretinoin 0.05% gel. Propionibacterium acnes were found in patients with mild acne vulgaris before the treatment of benzoyl peroxide 5% gel and tretinoin 0.05% gel, although not found in all samples.

Comparison of the Effectiveness of Tretinoin 0.05% Gel and Adapalene 0.1% Gel Based on Clinical Manifestations, and Sebum Levels in Mild Acne Vulgaris Patients

This study aimed to compare the effectiveness of tretinoin 0.05% gel and adapalene 0.1% gel by observing any changes in clinical manifestations and sebum levels before, during and after treatment. This study was carried out in public hospitals and network hospitals in the city of Makassar with double-blind prospective cohort of pre and post treatment. The research sample were thirty-eight patients with mild acne vulgaris who have been observed for the change in the clinical manifestations, measured levels of sebum with sebumeter. The results showed no significant difference between the use of tretinoin 0.05% gel and adapalene 0.1% gel in patients with mild acne vulgaris. There were significant changes of clinical manifestations of two treatment on day 7 and day 14. Levels of sebum by the administration of adapalene 0.1% gel decreased significantly (p <0.05) at day 42, faster than the 0.05% tretinoin gel.

Updated long-term safety from ongoing phase 3 trials of levodopa-carbidopa intestinal gel in patients with advanced Parkinson's disease

Updated long-term safety from ongoing phase 3 trials of levodopa-carbidopa intestinal gel in patients with advanced Parkinson's disease

Updated long-term safety from ongoing phase 3 trials of levodopa-carbidopa intestinal gel in patients with advanced Parkinson's disease

Objectives: To summarize the integrated long-term safety data of levodopa-carbidopa intestinal gel (LCIG/carbidopa-levodopa enteral suspension [CLES]) from four ongoing phase 3 studies through 31 March 2014.

Transcutaneous port for levodopa/carbidopa intestinal gel administration in Parkinson's disease.

To evaluate the safety and tolerability of the T-Port(®) for intestinal infusion of levodopa/carbidopa gel in patients with advanced Parkinson's disease (PD). This prospective study was carried out in 24 patients with PD (15 males, mean age 61.8 years, mean duration PD 18.7 years). All adverse device effects were evaluated at 2 weeks, 3 months and 6 months and until explantation or death. Post-operative complications were similar to endoscopic gastrojejunostomy placement (four peritoneal irritation, one pocket pain). Eight patients with prior experience with the endoscopic gastrojejunostomy preferred the T-Port. The total device experience was 83.6 years, and the average survival time was 3.6 (range 1.1-5.2) years. Six T-Ports were still in use, and two patients had died due to non-device-related reasons. Sixteen T-Ports had been explanted due to 15 stoma reactions (14 inflammations and one infection) and one tilting of the T-Port. The T-Ports were replaced with endoscopic gastrojejunostomy system as replacements with T-Ports were not part of the study. Only two device malfunctions occurred (one catheter breakage at 3 year post-implant and one T-Port leakage of levodopa/carbidopa gel). No tube kinking, dislocation or blockage occurred. The number of adverse device effects proved to be significantly lower as compared to the endoscopic gastrojejunostomy literature data. The T-Port is safe and well tolerated, and the low number of tube problems is a potential advantage compared with the endoscopic gastrojejunostomy system. Proper cleaning and local treatment of the stoma site around the T-Port are essential to prolong its longevity.