Metronidazole Cream Research Articles

Sucralfate plus Metronidazole ointment is as effective as Diltiazem ointment for treatment of acute fissure in ano – an open label randomized clinical trial

Background and objectives. Fissure in ano is one of the most common colorectal diseases seen by surgeons in daily practice. Currently medical management is the first line therapy for treating acute fissure in ano. Apart from general measures, various drugs like nitrates and calcium channel blockers are also used for topical application. Recently topical application of sucralfate and metronidazole are being advocated for in the same way, although there isn't much evidence for their effectiveness. In this study we have compared the efficacy of sucralfate (7% and Metronidazole (1%) ointment to the most commonly used diltiazem (2%) ointment for healing in acute fissure in ano and control of pain. Materials and methods. The present study was a randomized clinical trial with total 96 patients, 47 in the Sucralfate + Metronidazole group and 49 in the Diltiazem group. Both drugs were prescribed for 4 weeks in addition to general measures like sitz bath, laxatives and oral fluids. Patients were followed up at 2 and 4 weeks. Control of symptoms like pain, bleeding and healing of ulcers in both groups were assessed. Frequency or graphs were used for qualitative variables and Mean+/-SD for quantitative variables. Chi-square and t-test was applied for comparison of the two groups, and p-value <0.05 was taken for statistical significance. Results. Most patients were male and belonged to age group 30-50 years. Most patients in both groups improved on conservative treatment. The difference observed in key outcome parameters like control of pain, bleeding and healing of fissure in both groups weren’t found to be statistically significant. Sucralfate and Metronidazole didn’t have any incidence of adverse effects and was cheaper in price compared to diltiazem ointment. Conclusions. Sucralfate and Metronidazole was as effective as diltiazem in treating of acute fissure in ano and can be recommended if allergy and adverse reactions to diltiazem are encountered.

Использование метода многоволновой спектрофотометрии при контроле качества тизоля геля и метронидазола в новой мягкой лекарственной форме «Метронидазоль»

Introduction. For the introduction of new medicines into medical practice, a mandatory stage is quality control, which includes determining the quantitative content of active components using modern methods of pharmaceutical analysis. Tizol gel, included in soft dosage forms, is an independent pharmacologically active agent, therefore it is important to evaluate its content in complex medicinal preparations. Aim. To develop a method for quantitative determination of tizol gel and metronidazole in a new semisolid dosage form «Metronidazole» using multiple-wavelength spectrophotometry. Materials and methods. Pharmaceutical substance metronidazole, tizol gel, «Metronidazole» ointment containing 5% nitroimidazole in a tizol base was used for analysis. The studies were performed on spectrophotometer SF-2000 by multiple-wavelength spectrophotometry in the UV region. On the basis of experimental data, the metrological parameters of the developed analytical technique were calculated. Results and discussion. Experimental studies allowed us to justify the use of an acetate buffer solution with pH = 4 as the optimum solvent for the spectrophotometric analysis of tisol gel and metronidazole in the mixture. Analytical wavelengths (238 nm for tisol gel, 316 nm for metronidazole) were selected according to the UV spectra of the drugs obtained. According to the results of quantitative determination of the components of the Metronidazole ointment, the content of medicines is within the limits: metronidazole from 0.4900 to 0.5219 g, tizol gel (in terms of the mass fraction of titanium) – 2.32–2.46%, which are acceptable according to regulatory documentation (FSF 42-3157-06, OFS.1.8.0001). Conclusion. Quantitative analysis of tisol gel in complex pharmaceutical preparations was proposed for the first time. The method of quantitative determination by multiple-wavelength spectrophotometry has been developed which allows to determine the content of tizol gel and metronidazole in a new semisolid dosage form «Metronidazole» with relative errors of the average result not exceeding ± 3.00%.

Outcomes of additional local antibiotic to local analgesic and vasodilator in acute anal fissure - A randomized controlled study

Acute anal fissure is a common and painful condition of ano-rectal region characterized by tear in the anoderm causing pain during defecation. Mainstay of its treatment is pharmacotherapy with lifestyle modification. Current study was undertaken to evaluate the role of add-on local antimicrobial in recovery and relief of symptoms of acute anal fissure in comparison to local anesthetic and vasodilator without any antimicrobial. It was a randomized, assessor-blinded, active-controlled clinical study in which data of 68 eligible participants were analyzed. Participants of both group received local lignocaine and nifedipine and the test group (Group B) received metronidazole ointment in addition. Healing was assessed by clinical examination and pain by Numeric Pain Rating Scale. Sample size was calculated based upon result of older pilot study and the proportion of recovery were assessed by Chi-square test. After 6 weeks of treatment, 61 out of 68 (i.e., 89.7%) patients receiving add-on antimicrobial recovered completely compared to 75% of the comparator group. Reduction of pain and cessation of bleeding were also significantly better in patients receiving additional antibacterial. Healing and symptom relief in acute anal fissure is better with addition of local antibacterial along with local vasodilator and anesthetic.

Role of local antibiotics in the treatment of acute anal fissure.

Objective: To assess the role of topical antibiotic (mertronidazole) in the treatment of acute anal fissure. Study Design: Randomized Control Trial. Setting: General Surgery Outpatient Department of Aziz Fatima Hospital. Period: January 2020 and March 2021. Material & Method: In this study, patients were divided into two groups randomly. Patients in Group 1 were given only 0.2% GTN ointment and those in Group 2 were given 0.2% GTN ointment and metronidazole cream. All patients’ VAS scores for pain and healing of fissure by examining the peri anal area, as well as any adverse effects of the drugs, were recorded and statistically compared. Patients demographic characteristics, such as age and gender, were recorded. All patients were physically examined at the end of weeks 2, 4, and 6 of treatment. All statistical data analyses were performed using the Statistical Package for the Social Sciences (SPSS) version 23.0. Descriptive statistics were used for comparisons. t test, and chi-square test were used to assess independent samples. A p-value <0.05 was accepted as statistically significant. Results: There were 46 (92%) female and 4 (08%) male patients in Group 1 and 48 (96%) female and 2 (24%) male patients in Group 2. The mean ages of the patients were 35.4±3.7 years in Group 1 and 37.8±4.2 years in Group 2. The mean VAS scores of the patients at the time of presentation to the hospital (pretreatment) were 7.2±1.2 in Group 1 and 7.4±0.9 in Group 2 (p=0.058). The mean VAS scores of the patients at the end of week 2 were 4.6±0.8 in Group 1 and 4.2±0.9 in Group 2 (p=0.058). The mean VAS scores of the patients at the end of week 4 were 3.2±O.7 in Group 1 and 2.4±0.8 in Group 2 (p=0.00004). The mean VAS scores of the patients at the end of week 6 were 2.36+0.65 in Group 1 and 1.86±0.48 in Group 2 (p<0.00054). In Group 1, 6(12%) patients had recovery at week 4 and 26 (32%) patients at week 6 with no recovery seen in 18(36%) patients. In Group 2, 9 (18%) patients had recovery at week 2 and 33(66%) patients at week 4 with no recovery seen in 8(16%) patients. There was a statistically significant difference between these data (p=0.022). Conclusion: We have observed that topical metronidazole along with other traditional management is an fruitful, easy-to-use, safe, rapid and secure option that helps in further reducing pain associated with anal fissure and increasing the healing rate. It is also effective in preventing the anal fissure to become chronic.

The dose-duration effect on cutaneous pharmacokinetics of metronidazole from topical dermatological formulations in Yucatan mini-pigs

Dermal microdialysis (dMD) permits the investigation of cutaneous pharmacokinetics (cPK) for topical dermatological drug products (TDDP). dMD involves probe implantation into the dermis and a sample collection system that restricts subjects’ movements for the experimental duration. A truncated dose-duration, by TDDP removal at predetermined time-points, may help to adequately characterize the cPK in a relatively short time. The goals of this study were to: assess and compare the dose-duration effect on the dermal exposure of metronidazole (MTZ) containing TDDPs; and characterize MTZ dermal elimination following TDDP application and direct dermal delivery of MTZ utilizing a retrodialysis/microdialysis approach that we termed “dermal infusion.” MTZ cream and gel were applied on three Yucatan mini-pigs for dose-durations of 6-hr, 12-hr, or 48-hr. The gel’s dermal exposure was similar among the three dose-durations. Conversely, at the 6-hr dose-duration, the cream’s dermal exposure was significantly lower than other cream dose-durations while also comparable to the gel. In comparison, the 12-hr and 48-hr cream exposures were not significantly different. Terminal-phase half-live differences between the MTZ TDDP’s and dermal-infusion indicate flip/flop cPK. Truncating topical dose-duration may provide a valuable strategy to reduce experimental duration; however, dose-duration must be carefully selected if the goal is to discriminate between formulations.

Strategies to Reduce Post-Hemorrhoidectomy Pain: A Systematic Review.

Background and Objectives: Excisional hemorrhoidectomy is considered as a mainstay operation for high-grade hemorrhoids and complicated hemorrhoids. However, postoperative pain remains a challenging problem after hemorrhoidectomy. This systematic review aims to identify pharmacological and non-pharmacological interventions for reducing post-hemorrhoidectomy pain. Materials and Methods: The databases of Ovid MEDLINE, PubMed and EMBASE were systematically searched for randomized controlled trails (published in English language with full-text from 1981 to 30 September 2021) to include comparative studies examining post-hemorrhoidectomy pain as their primary outcomes between an intervention and another intervention (or a sham or placebo). Results: Some 157 studies were included in this review with additional information from 15 meta-analyses. Fundamentally, strategies to reduce post-hemorrhoidectomy pain were categorized into four groups: anesthetic methods, surgical techniques, intraoperative adjuncts, and postoperative interventions. In brief, local anesthesia-alone or combined with intravenous sedation was the most effective anesthetic method for excisional hemorrhoidectomy. Regarding surgical techniques, closed (Ferguson) hemorrhoidectomy performed with a vascular sealing device or an ultrasonic scalpel was recommended. Lateral internal anal sphincterotomy may be performed as a surgical adjunct to reduce post-hemorrhoidectomy pain, although it increased risks of anal incontinence. Chemical sphincterotomy (botulinum toxin, topical calcium channel blockers, and topical glyceryl trinitrate) was also efficacious in reducing postoperative pain. So were other topical agents such as anesthetic cream, 10% metronidazole ointment, and 10% sucralfate ointment. Postoperative administration of oral metronidazole, flavonoids, and laxatives was associated with a significant reduction in post-hemorrhoidectomy pain. Conclusions: This systematic review comprehensively covers evidence-based strategies to reduce pain after excisional hemorrhoidectomy. Areas for future research on this topic are also addressed at the end of this article.

Evaluation of changes in laser Doppler flowmetry indices in patients with a combined subtype of rosacea under the influence of a course of complex phototherapy

BACKGROUND: The development of new methods for the treatment of rosacea, as well as a combination of various methods of physiotherapy, is of scientific and practical interest. In this work, the assessment of changes in microcirculation indices under complex phototherapy has been carried out.
 AIMS: Тo assess changes in microcirculation indices in patients with a combination of rosacea subtypes according to laser Doppler flowmetry under a course of complex phototherapy.
 MATERIAL AND METHODS: In 20172020 a randomized controlled study of 130 patients with a combination of rosacea subtypes. All patients were divided into 4 groups. In each separate group, laser therapy and 1% metronidazole cream were used (group I); phototherapy and 1% metronidazole cream (group II); complex photolaser therapy and 1% metronidazole cream (group III); in the comparison group (group IV), patients show only 1% metronidazole cream. The treatment, the duration of which was 3 months, included 6 sessions with an interval of 2 weeks. The effectiveness of therapy was assessed according to the data of laser Doppler flowmetry, reflecting changes in the hemodynamics of the microvasculature in the affected skin areas.
 RESULTS: The developed complex method, including exposure to intense pulsed light (intense pulsed light, IPL) 5201100 nm in combination with submillisecond neodymium laser radiation 1064 nm (submilisecond Nd: YAG laser 1064 nm) and daily application of 1% metronidazole cream showed the most pronounced improvement in the state of microcirculation according to laser Doppler flowmetry in comparison with the rest groups. Against the background of the course of complex phototherapy for all patients with the combined subtype of rosacea, statistically significant changes were in the volume of blood flow, modulation coefficients, coefficient of variation. On the contrary, no statistically significant changes were found in the ranges corresponding to active regulatory factors endothelial, neurogenic, myogenic, and passive respiratory and cardiac, as well as in the T index.
 CONCLUSION: After the course of complex phototherapy in the group of patients with a combination of rosacea subtypes, there was a decrease in the severity of clinical manifestations of diseases, as well as an improvement in the main indicators of microcirculation according to laser Doppler flowmetry.

Topical Versus Oral Metronidazole After Excisional Hemorrhoidectomy: A Double-Blind Randomized Controlled Trial.

Both topical and oral metronidazole have been shown to reduce pain after excisional hemorrhoidectomy. Although recent meta-analyses have demonstrated efficacy against placebo, there has been no comparison between the 2 routes. This study aims to investigate whether topical or oral metronidazole provides the most analgesic properties after excisional hemorrhoidectomy. A prospective, double-blind, randomized controlled trial was performed. This trial was conducted at 2 hospitals in New Zealand between March 2019 and February 2020. Adults undergoing elective excisional hemorrhoidectomy for grade III/IV hemorrhoids were randomized. Participants were randomized to receive either topical metronidazole ointment and an oral placebo versus oral metronidazole with a placebo ointment for 7 days. The primary outcome was daily pain scores for 7 days, estimated using a generalized linear mixed model fitted with time and treatment arm and tested for interaction with time and treatment arm. Secondary outcomes included additional analgesia, return to normal activity, recovery scores, and adverse effects. A total of 120 participants were included, with 60 in each group. A unimodal peak of pain was recorded with the maximum at days 3 and 4, but there was no significant difference in resting pain scores, with a mean difference at day 3 of 0.47 (-0.48, 1.42). There were no significant differences for secondary outcomes. Fourteen (11.7%) participants were readmitted, without significant difference between groups. Fifty-nine percent of participants preferred topical analgesic compared with 31% who preferred oral and 9.7% who had no preference. This was a pragmatic study in which we could not have stopped participants seeking other analgesics and with less than perfect complete compliance. Postoperative oral and topical metronidazole provide similar analgesia after excisional hemorrhoidectomy. The route should depend on patient preference, with topical administration potentially benefiting from improved antimicrobial stewardship and having less effect on the gut microbiome. See Video Abstract at http:/links.lww.com/DCR/B853 .METRONIDAZOL TÓPICO VERSUS ORAL DESPUÉS DE UNA HEMORROIDECTOMÍA POR ESCISIÓN: UN ENSAYO CONTROLADO ALEATORIO DOBLE CIEGO. Se ha demostrado que tanto el metronidazol tópico como el oral reducen el dolor después de una hemorroidectomía por escisión. Aunque los metaanálisis más recientes han demostrado eficacia frente al placebo, no ha habido comparación entre las dos vías. Este estudio tiene como objetivo investigar si el metronidazol tópico u oral proporciona las propiedades más analgésicas después de una hemorroidectomía por escisión. Se realizó un ensayo prospectivo, controlado, aleatorio, a doble ciego. Este ensayo fue realizado en dos hospitales de Nueva Zelanda entre marzo de 2019 y febrero de 2020. Se asignaron al azar pacientes adultos sometidos a hemorroidectomía por escisión electiva por hemorroides de grado III / IV. Los participantes fueron asignados al azar para recibir un ungüento de metronidazol tópico y un placebo oral versus metronidazol oral con un ungüento de placebo durante siete días. El resultado primario fueron las puntuaciones diarias de dolor durante siete días, estimadas mediante un modelo lineal mixto generalizado ajustado tanto con el tiempo y el brazo de tratamiento y probado para la interacción con el tiempo y el brazo de tratamiento. Los resultados secundarios incluyen analgesia adicional, retorno a la actividad normal, puntuaciones de recuperación y efectos adversos. Se incluyó un total de 120 participantes, 60 en cada grupo. Se registró un pico de dolor unimodal con el máximo en los días 3 y 4, pero no hubo diferencias significativas en las puntuaciones de dolor en reposo, con una diferencia media en el día 3 de 0,47 (-0,48, 1,42). No hubo diferencias significativas para los resultados secundarios. Catorce (11,7%) participantes fueron readmitidos, sin diferencias significativas entre los grupos. El cincuenta y nueve por ciento de los participantes prefirió el tópico, en comparación con el 31% por vía oral y el 9,7% sin preferencia. Este fue un estudio pragmático en el que no pudimos haber impedido que los participantes buscaran otros analgésicos, con un cumplimiento completo menos que perfecto. El metronidazol posoperatorio por vía oral o tópica proporciona una analgesia similar después de una hemorroidectomía por escisión. La vía debe depender de la preferencia del paciente, y la administración tópica se beneficia potencialmente por una mejor protección de los antimicrobianos y un menor efecto sobre el microbioma intestinal. Consulte Video Resumen en http://links.lww.com/DCR/B853 . (Traducción-Dr Osvaldo Gauto).

Stability study of metronidazole cream, extemporaneously made in pharmacy

Abstract Background Rosacea is a chronic recurrent disease, characterized by facial redness, dilated blood vessels, inflammatory rash elements on the face. The pharmacy produces 2% metronidazole cream extemporaneously for the treatment of the disease, as there is no such cream concentration on the market. The treatment of the disease is usually long, so the shelf life of the cream is very important for the patient, especially for those who do not have the opportunity to reach the manufacturing pharmacy. The aim of this investigation was to determine the stability and shelf life of metronidazole cream. Methods Long-term stability study of metronidazole cream was applied at 25 ± 2° C, 60 ± 5% relative humidity; accelerated stability test at 40 ± 2 °C, 75 ± 5% relative humidity. The influence of stress conditions were evaluated on the stability of metronidazole cream. It was determined metronidazole cream texture and microbiological examination was applied. Results It was found that color (white), odor (odorless), integrity (homogeneous), pH (6.8) did not change during storage of metronidazole (6 months). Mechanical properties of the metronidazole cream: firmness, shear, consistency and cohesion throughout the study remained stable. High performance liquid chromatography in the full stability study showed that metronidazole concentrations did not fluctuate within ± 5%. Stress factors such as acid media, alkaline media, hydrogen peroxide, daylight and heat did not affect the stability of the cream. A microbiological examination of the metronidazole cream suited European Pharmacopoeia requirements. Conclusions The extemporaneously made metronidazole cream were stable for 6 months.

Assessment of the dynamics of indicators of morphological and functional characteristics of the skin in patients with the combined subtype of rosacea under the influence of complex phototherapy

Rosacea is a common chronic inflammatory dermatosis of vascular origin, characterized by a lesion of the face skin in the form of erythema and papulopustular elements. Taking into account the new research devoted to the treatment of rosacea, it is of scientific and practical interest to develop new methods for the treatment of this dermatosis using complex physiotherapy approaches and their synergy, for example, IPL radiation (without the use of photo filters) and submilisecond neodymium 1,064nm laser radiation. Material and methods. The study included 130patients with the combined subtype of rosacea (CSR) with varying degrees of severity of ETR and PPR. In order to study the effectiveness of complex photo- and laser therapy of CSR, all patients were divided into 4groups by simple randomization (envelope method). The treatment of the patients in each separate group included: group I — laser therapy and 1% metronidazole cream; group II — phototherapy and 1% metronidazole cream; group III — complex photo-laser therapy and 1% metronidazole cream; group IV — comparison group, patients received only 1% metronidazole cream. This work takes into account the synergism of both physiotherapeutic effects provided by non-truncated (without the use of photo filters) IPL radiation and submilisecond neodymium 1,064 nm laser radiation, as well as the increased destruction of pathologically altered vessels observed during the sequential use of both procedures, and the developed original method of treating patients with CSR. Conclusion. Based on the obtained results, it was concluded that the maximum improvement in the morphofunctional parameters of the skin was in the third group of patients with CSR. The increase in the hydration index of the skin exceeded the indicators of the other groups of patients with CSR. Also, the intensity of sebum production decreased most significantly. There was a maximum narrowing of the excretory ducts of the sebaceous glands, while in the other groups, the narrowing of the excretory ducts of the sebaceous glands occurred to a lesser and equal extent. Such changes reflect the pronounced effect of complex phototherapy on the tone of the sphincter of the excretory duct, the intensity of sebum production, as well as on the synthesis of collagen and elastin, which is reflected in the maximum approximation to the indicators of the group of healthy volunteers of such characteristics as «hydration» and «smoothness».

Assessment of the dynamics of indicators of morphological and functional characteristics of the skin in patients with the combined subtype of rosacea under the influence of complex phototherapy

Rosacea is a common chronic inflammatory dermatosis of vascular origin, characterized by a lesion of the face skin in the form of erythema and papulopustular elements. Taking into account the new research devoted to the treatment of rosacea, it is of scientific and practical interest to develop new methods for the treatment of this dermatosis using complex physiotherapy approaches and their synergy, for example, IPL radiation (without the use of photo filters) and submilisecond neodymium 1,064 nm laser radiation. Material and methods: The study included 130 patients with the combined subtype of rosacea (CSR) with varying degrees of severity of ETR and PPR. In order to study the effectiveness of complex photo- and laser therapy of CSR, all patients were divided into 4 groups by simple randomization (envelope method). The treatment of the patients in each separate group included: group I — laser therapy and 1% metronidazole cream; group II — phototherapy and 1% metronidazole cream; group III — complex photo-laser therapy and 1% metronidazole cream; group IV — comparison group, patients received only 1% metronidazole cream. This work takes into account the synergism of both physiotherapeutic effects provided by non-truncated (without the use of photo filters) IPL radiation and submilisecond neodymium 1,064 nm laser radiation, as well as the increased destruction of pathologically altered vessels observed during the sequential use of both procedures, and the developed original method of treating patients with CSR. Conclusion: Based on the obtained results, it was concluded that the maximum improvement in the morphofunctional parameters of the skin was in the third group of patients with CSR. The increase in the hydration index of the skin exceeded the indicators of the other groups of patients with CSR. Also, the intensity of sebum production decreased most significantly. There was a maximum narrowing of the excretory ducts of the sebaceous glands, while in the other groups, the narrowing of the excretory ducts of the sebaceous glands occurred to a lesser and equal extent. Such changes reflect the pronounced effect of complex phototherapy on the tone of the sphincter of the excretory duct, the intensity of sebum production, as well as on the synthesis of collagen and elastin, which is reflected in the maximum approximation to the indicators of the group of healthy volunteers of such characteristics as «hydration» and «smoothness».

UTILIZATION OF ISOLATED THERAPEUTIC BACTERIA IN TOPICAL OINTMENT FOR INFECTION TREATMENT

This study includes the using therapeutic bacteria isolate in topical ointment for bacterial vaginosis treatment and to compare it with metronidazole ointment that use in a clinical trial under medical supervision. Four active Lactobacillus probiotics bacteria were cultured in %12 skim milk , three of these bacteria were commercial types and one Iraqi local isolate , the total bacterial count of probiotics bacteria were around ≥ 1012 cfu/ml . %10 of individually culture free cells filtrate were added to Muller Hinton broth with secretions of patients infected with bacterial vaginosis "BV", %50 of natural organic components and %50 of local isolate Lactobacillus plantarum cultured in skim milk were mixed to prepare the natural ointment. Eighty-nine BV volunteers were divided into two group, first was 43 volunteers used probiotic ointment, the second group was 46 volunteers used metronidazole ointment "as control group", both groups were under medical observation for two weeks. The results shown that Iraqi local isolate Lb . plantarum gave best inhibition in vitro, according to Amsel criteria the rate of healing with Lb . plantarum ointment group was %97.87, it was higher than metronidazole ointment %91.30 and the healed cases numbers were increased at the day 7 and 14,it has been noticed that the results were positive based on vaginal secretions, and whiff test, clue cell and the pH was above 4.5 shown significant progress. According to Nugent criteria Lb . plantarum ointment gave higher healing percentage which was %95.35.

Assessment of the dynamics of dermatologic index indicators of symptom scale and dermatologic quality of life index under the influence of complex phototherapy in patients with a combination of rosacea subtypes

Background. Taking into account the data of recent studies on the treatment of rosacea, the development of new methods of treating this dermatosis using complex physiotherapeutic approaches and their synergism is of scientific and practical interest. In this work, we took into account the synergism of physiotherapeutic effects exerted by intense pulsed light and submilisecond neodymium 1064 nm laser radiation, as well as an increase in the destruction of pathologically altered vessels observed with the sequential use of both procedures.
 Aims: to assess the effect of complex phototherapy on changes in the indicators of the dermatological index of the symptom scale and the dermatological index of quality of life, reflecting the effect of the therapy on the clinical manifestations of the disease and the patient's subjective assessment of the skin condition.
 Material and methods. In the period 20172020 we conducted a randomized controlled study in which 130 patients with a combination of rosacea subtypes took part. All patients were divided into 4 groups. In each separate group, the following types of therapy were used: in group I laser therapy and 1% metronidazole cream; in group II phototherapy and 1% metronidazole cream; in group III complex photo-laser therapy and 1% metronidazole cream; in the comparison group (IV), patients received only 1% metronidazole cream. The treatment included 6 sessions with an interval of 2 weeks, with a total duration of 3 months. The effectiveness of therapy was assessed according to the results of the dermatological index of quality of life (DQL) and the dermatological index of the symptom scale (DYS) before and after treatment.
 Results. The developed complex method of combination of rosacea subtypes therapy demonstrated maximum efficiency, which was reflected in the maximum (by 55.21%) decrease in DYS in group III compared with the other three groups: in group I, the decrease in DYS was 30.54%, in II 21.51%, in IV 21.56%. The DQL in group III decreased by 67.4%, which was significantly higher than the indicators of the other three groups: in group I, DQL decreased by 31.3%, in group II by 27.4%, in IV by 20.7%.
 Conclusion. After the course of complex phototherapy in the group of patients with combination of rosacea subtypes, there was a decrease in the severity of clinical manifestations of the disease, as well as an increase in the quality of life of patients according to the data of the DYS and DQL, respectively.

A Rapid Tool to Optimize Process Variables for Continuous Manufacturing of Metronidazole Ointment Using Melt Extrusion Technique.

The use of hot-melt extrusion (HME) technique in the preparation of semi-solid products offers several advantages over conventional processes. However, the optimization of the technique for preparation of semi-solid pharmaceuticals is challenging due to involvement of ingredients with different physical properties. Hence, a simple tool to optimize the mixing of ingredients that results in a target ratio and drug content uniformity is utmost important. In this study, a handheld colorimeter has been explored to optimize the process variables of twin screw processor for preparation of hydrophilic PEG-based ointment. The process parameters which were optimized with use of handheld colorimeter have been used for preparation of polyethylene glycol-based metronidazole ointment. The metronidazole ointment prepared by twin screw processor was compared with commercially available metronidazole gel for in vitro release testing and ex vivo permeation. The flux, ex vivo bioavailability, and Tmax of polyethylene glycol-based metronidazole ointment was found to be similar to that of marketed metronidazole gel.

Different Types of Gel Carriers as Metronidazole Delivery Systems to the Oral Mucosa.

Periodontal diseases are some of the most widespread oral afflictions, and they are labeled as chronic infections caused by the accumulation of bacteria in dental plaque that produces localized inflammation of the periodontium. The use of local drug delivery systems to treat periodontal diseases has received greater attention, because the active substance is targeted directly to the affected area, which minimizes its systemic side effects. Therefore, the purpose of the investigation was to develop and characterize different types of gel formulations—bigel, hydrogel and oleogel—as local delivery systems containing metronidazole (MET), which can be applied to the oral mucosa. The influence of the formulation type on the mechanical, rheological and mucoadhesive properties were examined. Moreover, in vitro release of metronidazole, its ex vivo permeation through buccal porcine mucosa and antimicrobial activity measured by the plate diffusion method were estimated. It was found that the gel formulations obtained were non-Newtonian systems, showing a shear-thinning behavior and thixotropic properties with good textural features such as firmness, compressibility and adhesiveness. Moreover, the preparations designed possessed beneficial mucoadhesive properties. The formulated hydrogels and bigels containing micronized MET were considered as better formulations in terms of drug release and antimicrobial activity compared to commercially available metronidazole ointment. An ex vivo permeation study with the use of porcine buccal mucosa demonstrated that the bigel formulation was characterized by higher initial permeability rate providing a fast therapeutic effect with simultaneous moderate retention in mucosal tissue to decrease the risk of local cytotoxicity.

Metronidazole Ointment in Non-healing Pilonidal Sinus Wounds

Metronidazole Ointment in Non-healing Pilonidal Sinus Wounds

Rosacea Treatment Satisfaction: Matching Adjusted Indirect Treatment Comparison Analysis of Metronidazole Gel or Cream vs Azelaic Acid Foam

To assess differences in patient-reported treatment side effects and concerns associated with azelaic acid 15% foam (AAF) vs metronidazole cream (MC) and metronidazole gel (MG). This study used matching-adjusted indirect comparison (MAIC) to compare patient-reported outcomes from survey data evaluating rosacea treatments. Outcomes of interest included percentages of patients reporting concerns and side effects and measures of importance of the concerns and tolerability of the side effects. Patients in each analysis (MG vs AAF and MC vs AAF) were matched using stabilized inverse propensity scores. When compared to AAF, MG-treated patients more frequently reported concerns with treatment efficacy (54% vs 4%), application (7% vs 3%), and treatment side effects. MC-treated patients more frequently reported concerns with treatment efficacy (61% vs 5%) and dryness (8% vs 5%). AAF-treated patients more frequently reported concerns with cost of treatment compared with MG (7% vs 1%) and MC (9% vs 4%). Among patients reporting concerns, level of importance associated with these concerns was similar for AAF-treated patients compared with MG- and MC-treated patients. When compared to AAF-treated patients, MG-treated patients more frequently reported side effects of dryness (26% vs 15%) and uneven skin tone (3% vs 0%), and MC-treated patients more frequently reported side effects of burning (7% vs 3%), itching (7% vs 5%), and redness (7% vs 5%). MG- and MC-treated patients indicated greater intolerance for reported side effects than AAF-treated patients. MG- and MC-treated patients more frequently reported treatment concerns and side effects than AAF-treated patients, and tolerability of those side effects was higher for patients treated with AAF. While treatment cost is a more frequent concern in patients treated with AAF, these patients less frequently reported concerns with treatment efficacy and reported similar or greater tolerance to side effects than patients treated with either MC or MG. J Drugs Dermatol. 2020;19(3): doi:10.36849/JDD.2020.3679.

Efficacy of treatments for Demodex blepharitis: A systematic review and meta-analysis

PurposeWe conducted a systematic review and meta-analysis to evaluate the efficacy of different treatment for Demodex blepharitis. Parameters studied were mites count, improvement of symptoms and mites’ eradication, stratified on type of treatments and mode of delivery of treatments (local or systemic). MethodThe PubMed, Cochrane Library, Embase, ClinicalTrials.gov, Google scholar and Science Direct databases were searched for studies reporting an efficacy of treatments for Demodex blepharitis. ResultsWe included 19 studies (14 observational and 5 randomized clinical trials), for a total of 934 patients, 1741 eyes, and 13 different treatments. For mites count, eradication rate, and symptoms improvement, meta-analysis included fifteen, fourteen and thirteen studies, respectively. The overall effect sizes for efficiency of all treatments, globally, were 1.68 (95CI 1.25 to 2.12), 0.45 (0.26–0.64), and 0.76 (0.59–0.90), respectively. Except usual lid hygiene for mites count, Children's Hospital of Eastern Ontario ointment (CHEO) for both eradication rate and symptoms, and CHEO, 2% metronidazole ointment, and systemic metronidazole for eradication rate, all treatments were efficient. Stratified meta-analysis did not show significant differences between local and systemic treatments (1.22, 0.83 to 1.60 vs 2.24, 1.30 to 3.18 for mites count; 0.37, 0.21 to 0.54 vs 0.56, 0.06 to 0.99 for eradication rate; and 0.77, 0.58 to 0.92 vs 0.67, 0.25 to 0.98 for symptoms improvement). ConclusionWe reported the efficiency of the different treatments of Demodex blepharitis. Because of less systemic side effects, local treatments seem promising molecules in the treatment of Demodex blepharitis.

Could local antibiotics be included in the treatment of acute anal fissure?

Acute anal fissure is a very common disorder of the anorectal region. Its most widely used treatment method is the medications given in addition to conservative therapies. The objective of the present study was to investigate the effects of local metronidazole use in the treatment of acute anal fissure on the symptoms and remission processes of the patients. This was a prospective, randomized, controlled clinical study conducted on 100 consecutive patients who presented to our clinic between March 2016 and March 2017 and who were diagnosed with acute anal fissure. Patients were randomly divided into two groups of 50 persons. Patients in Group 1 were given only 5% lidocaine pomade as a local anesthesia, and those in Group 2 were given 5% lidocaine pomade and metronidazole cream. Patients applied the medications topically to the anal margin 3 times per day for 4 weeks. Patients' demographic characteristics, such as age and gender, were recorded. All patients were invited for check-up at the end of weeks 1, 2, and 4 of treatment. The Visual Analogue Scale scores for pain and the healing status of their fissure by visual inspection, as well as any adverse effects of the drugs, were recorded. The results were compared statistically. A p-value <0.05 was considered significant. The mean ages of the patients were 34.2±4.1 years in Group 1 and 36.6±3.8 years in Group 2. As a result of the statistical comparison of the Visual Analogue Scale scores, there was a statistically significant difference between the two groups at the end of weeks 2 and 4 (p=0.004 and p<0.001, respectively). In Group 1, 28 (56%) patients recovered, but no recovery was observed in 22 (44%) patients. In Group 2, 43 (86%) patients recovered, whereas 7 (14%) patients had no recovery (p=0.004). The topical antimicrobial treatment with metronidazole as an addition to the classical medical treatments in acute anal fissure is an effective and safe practice resulting in further reduction in pain and increased healing rate.

New combined topical therapy for refractory rosacea

The main pathogenetic aspects of rosacea, various classifications of dermatosis and the modern clinical classification are presented. The symptoms of different forms of rosacea are described. Contradictory of modern scientific concepts of different researchers, approaches to etiology, pathogenesis and treatment has been noted. The main triggers for the manifestation of rosacea, which should be tak en into account to achieve the maximum effect in the treatment of the disease, are indicated. The first domestic positive experience of authors with 1 % ivermectin cream and 0.03 % tacrolimus ointment is presented. The high efficacy and very good tolerability of this combination, compared to monotherapy of 1 % ivermectin cream and traditional therapy of metronidazole cream and azelaic acid gel as well as the absence of any side effects in patients with moderate to severe rosacea are shown.