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The Cochrane Database of Systematic... Nov 2016Incontinence-associated dermatitis (IAD) is one of the most common skin problems in adults who are incontinent for urine, stool, or both. In practice, products and... (Review)
Review
BACKGROUND
Incontinence-associated dermatitis (IAD) is one of the most common skin problems in adults who are incontinent for urine, stool, or both. In practice, products and procedures are the same for both prevention and treatment of IAD.
OBJECTIVES
The objective of this review was to assess the effectiveness of various products and procedures to preventand treat incontinence-associated dermatitis in adults.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 September 2016). Additionally we searched other electronic databases: CENTRAL(2015, Issue 4), MEDLINE (January 1946 to May Week 3 2015), MEDLINE In-Process (inception to 26 May 2015), CINAHL(December 1981 to 28 May 2015), Web of Science (WoS; inception to 28 May 2015) and handsearched conference proceedings (to June 2015) and the reference lists of relevant articles, and contacted authors and experts in the field.
SELECTION CRITERIA
We selected randomised controlled trials (RCTs) and quasi-RCTs, performed in any healthcare setting, with included participants over 18 years of age, with or without IAD. We included trials comparing the (cost) effectiveness of topical skin care products such as skin cleansers, moisturisers, and skin protectants of different compositions and skin care procedures aiming to prevent and treat IAD.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles, abstracts and full-texts, extracted data, and assessed the risk of bias of the included trials.
MAIN RESULTS
We included 13 trials with 1295 participants in a qualitative synthesis. Participants were incontinent for urine, stool, or both, and were residents in a nursing home or were hospitalised.Eleven trials had a small sample size and short follow-up periods. .The overall risk of bias in the included studies was high. The data were not suitable for meta-analysis due to heterogeneity in participant population, skin care products, skin care procedures, outcomes, and measurement tools.Nine trials compared different topical skin care products, including a combination of products. Two trials tested a structured skin care procedure. One trial compared topical skin care products alongside frequencies of application. One trial compared frequencies of application of topical skin care products.We found evidence in two trials, being of low and moderate quality, that soap and water performed poorly in the prevention and treatment of IAD (primary outcomes of this review). The first trial indicated that the use of a skin cleanser might be more effective than the use of soap and water (risk ratio (RR) 0.39, 95% confidence interval (CI) 0.17 to 0.87; low quality evidence). The second trial indicated that a structured skin care procedure, being a washcloth with cleansing, moisturising, and protecting properties, might be more effective than soap and water (RR 0.31, 95% CI 0.12 to 0.79; moderate quality evidence). Findings from the other trials, all being of low to very low quality, suggest that applying a leave-on product (moisturiser, skin protectant, or a combination) might be more effective than not applying a leave-on product. No trial reported on the third primary outcome 'number of participants not satisfied with treatment' or on adverse effects.
AUTHORS' CONCLUSIONS
Little evidence, of very low to moderate quality, exists on the effects of interventions for preventing and treating IAD in adults. Soap and water performed poorly in the prevention and treatment of IAD. Application of leave-on products (moisturisers, skin protectants, or a combination) and avoiding soap seems to be more effective than withholding these products. The performance of leave-on products depends on the combination of ingredients, the overall formulation and the usage (e.g. amount applied). High quality confirmatory trials using standardised, and comparable prevention and treatment regimens in different settings/regions are required. Furthermore, to increase the comparability of trial results, we recommend the development of a core outcome set, including validated measurement tools. The evidence in this review is current up to 28 September 2016.
Topics: Administration, Topical; Adult; Amitriptyline; Dermatitis; Dermatologic Agents; Fecal Incontinence; Humans; Petrolatum; Randomized Controlled Trials as Topic; Skin Care; Skin Cream; Soaps; Urinary Incontinence; Zinc Oxide
PubMed: 27841440
DOI: 10.1002/14651858.CD011627.pub2 -
Pharmaceutical Research Oct 2018Ophthalmic ointments are unique in that they combine features of topical drug delivery, the ophthalmic route and ointment (semisolid) formulations. Accordingly, these... (Review)
Review
Ophthalmic ointments are unique in that they combine features of topical drug delivery, the ophthalmic route and ointment (semisolid) formulations. Accordingly, these complex formulations are challenging to develop and evaluate and therefore it is critically important to understand their physicochemical properties as well as their in vitro drug release characteristics. Previous reports on the characterization of ophthalmic ointments are very limited. Although there are FDA guidance documents and USP monographs covering some aspects of semisolid formulations, there are no FDA guidance documents nor any USP monographs for ophthalmic ointments. This review summarizes the physicochemical and in vitro profiling methods that have been previously reported for ophthalmic ointments. Specifically, insight is provided into physicochemical characterization (rheological parameters, drug content and content uniformity, and particle size of the API in the finished ointments) as well as important considerations (membranes, release media, method comparison, release kinetics and discriminatory ability) in in vitro release testing (IVRT) method development for ophthalmic ointments. Graphical Abstract Summary of the physicochemcial profiling and in vitro drug release testing (IVRT) for ophthalmic ointments.
Topics: Administration, Ophthalmic; Administration, Topical; Animals; Drug Compounding; Drug Delivery Systems; Drug Liberation; Humans; Ointments; Particle Size; Petrolatum; Pharmaceutical Preparations; Rheology
PubMed: 30324424
DOI: 10.1007/s11095-018-2513-3 -
In Silico Pharmacology 2022Meclizine is antihistamine and is used in combination with pyridoxine to treat motion sickness. The in-silico study of meclizine prediction studied showed that meclizine...
Meclizine is antihistamine and is used in combination with pyridoxine to treat motion sickness. The in-silico study of meclizine prediction studied showed that meclizine has anti-eczema activity with possible activity 95. This research aimed to explore the anti-eczema activity of meclizine. Therefore, five formulations of meclizine ointment have been prepared using different bases (white base, simple ointment base, hydrophilic petrolatum base, hydrophilic, and emulsifying ointment bases). The efficiency of meclizine ointment has been evaluated by testing the physical compatibility and stability, homogeneity and irritant effect, absorbance and spreadability, chemical identification, calibration curve, drug content (assay), and dissolution test. This is followed by evaluating the ointment's effectiveness on volunteers and molecular docking. Five creams trials have been prepared, and two formulas (F3, and F5) have been selected for further evaluation. The formulas three and five (F3, F5) have passed the physical and chemical tests and showed compatibility, homogenous, absorbed, non-irritant, and stable with calibration curve (R = 0.9999). Then, the F3 formula was selected by testing them on seven volunteers after evaluating the irritant test. Four of the volunteers showed excellent recovery, and three of the volunteers suffered from uncomforting feelings and the formation of new pills. Therefore, F5 has been tested by eight volunteers that contain high oleaginous activity; five showed an excellent recovery, while three of the volunteers showed no difference. According to that, F5 is more efficient for eczema patients than F3, and Meclizine showed promising activity as an anti-eczema that requires further evaluation in the future.
PubMed: 36062215
DOI: 10.1007/s40203-022-00129-x -
Journal of the European Academy of... Jun 2022Benzyl alcohol is a widely used preservative, solvent and fragrance material. According to published data, it is a rare sensitizer in humans.
BACKGROUND
Benzyl alcohol is a widely used preservative, solvent and fragrance material. According to published data, it is a rare sensitizer in humans.
OBJECTIVES
To identify characteristics and sensitization patterns of patients with positive patch test reactions to benzyl alcohol and to check the reliability of the patch test preparation benzyl alcohol 1% pet.
PATIENTS AND METHODS
Retrospective analysis of data from the Information Network of Departments of Dermatology (IVDK), 2010-2019.
RESULTS
Of 70 867 patients patch tested with benzyl alcohol 1% pet., 146 (0.21%) showed a positive reaction, most of them (89%) only weakly positive. The number of doubtful and irritant reactions significantly exceeded the number of positive reactions. Reproducibility of positive test reactions was low. Among benzyl alcohol-positive patients, compared to benzyl alcohol-negative patients, there were significantly more patients with leg dermatitis (17.8% vs. 8.6%), more patients aged 40 years or more (81.5% vs. 70.5%) and more patients who were tested because of a suspected intolerance reaction to topical medications (34.9% vs. 16.6%). Concomitant positive reactions were mainly seen to fragrances, preservatives and ointment bases.
CONCLUSIONS
Sensitization to benzyl alcohol occurs very rarely, mainly in patients with stasis dermatitis. In view of our results, benzyl alcohol cannot be regarded as a significant contact allergen, and therefore marking it as skin sensitizer 1B and labelling it with H 317 is not helpful.
Topics: Allergens; Benzyl Alcohol; Dermatitis, Allergic Contact; Humans; Patch Tests; Perfume; Preservatives, Pharmaceutical; Reproducibility of Results; Retrospective Studies
PubMed: 35080274
DOI: 10.1111/jdv.17968 -
Biomedicine & Pharmacotherapy =... Jun 2022The phytochemical analysis of the investigated Immortelle essential oil revealed the presence of monoterpenes and sesquiterpenes as major components that might be...
The phytochemical analysis of the investigated Immortelle essential oil revealed the presence of monoterpenes and sesquiterpenes as major components that might be efficient as a wound healing potential agent. The present study aimed to develop an ointment based on the Immortelle essential oil and investigate its wound healing effects on excision wounds in diabetic rats. The topical formulated Immortelle ointment was subjected to pharmaco-technical characterization. Thirty-two diabetic rats with the induced excision wound were used to evaluate in vivo wound healing effects of ointment. The animals were randomly divided into four groups untreated or topically treated with either a 1% silver sulfadiazine, the ointment base, or Immortelle ointment. The response to the treatment was assessed by macroscopic, biochemical and histopathological analysis. The ointment, compatible with the skin remained stable for 6 months. Topical application of the Immortelle ointment showed the highest wound contraction with the highest content of hydroxyproline in comparison to the all examined groups. The Immortelle ointment showed significant wound contraction from day 7 to day 21 as compared to other groups. On the day 21, there was an average of 99.32% wound contraction in the Immortelle group, whereas the mean wound contraction in the negative control and ointment base group was 71.36% and 81.26% respectively. The histopathological results validated the potential wound healing effect of Immortelle ointment with evident post-excision scar maturation and increased collagen fibers density. Our findings revealed that the Immortelle ointment approach might serve as a promising and innovative tool for wound healing.
Topics: Animals; Diabetes Mellitus, Experimental; Oils, Volatile; Ointment Bases; Ointments; Rats; Skin; Wound Healing
PubMed: 35429742
DOI: 10.1016/j.biopha.2022.112941 -
Biological & Pharmaceutical Bulletin 2023Wound-healing deficits of the skin, one of the most common complications in patients with diabetes, delay wound healing, significantly reducing the patient's QOL....
Wound-healing deficits of the skin, one of the most common complications in patients with diabetes, delay wound healing, significantly reducing the patient's QOL. Therefore, the topical treatment of wound areas with drug-containing ointments and dressings is important. In this study, we investigated the effect of various ointment bases on skin wound healing in normal and streptozotocin-induced diabetic rats (STZ rats). Three ointment bases were used: white ointment (oil-based), absorbent cream (emulsion-based, w/o), and macrogol ointment (water-based). Skin wound healing in STZ rats was delayed compared with that in normal rats. Each of the three ointment bases was applied to the skin wound area in normal rats, and there was no difference in the therapeutic effect. The therapeutic effect of both white ointment and absorbent cream was higher in the STZ rats group than that in the non-treated group, and delayed wound healing was observed in STZ rats treated with macrogol ointment. In conclusion, skin wound healing in STZ rats is affected by the properties of the ointment base, and it is important to use an ointment base that controls the drying of the wound area in STZ rats. These findings provide information for the selection of ointment bases useful for application to skin wounds in patients with diabetes.
Topics: Rats; Animals; Ointment Bases; Ointments; Streptozocin; Diabetes Mellitus, Experimental; Quality of Life; Skin; Polyethylene Glycols
PubMed: 37121696
DOI: 10.1248/bpb.b22-00871 -
Gels (Basel, Switzerland) Nov 2023The purpose of this work was to develop a novel topical formulation of econazole nitrate based on gel that can be easily scaled up in one pot for the potential treatment...
The purpose of this work was to develop a novel topical formulation of econazole nitrate based on gel that can be easily scaled up in one pot for the potential treatment of fungal and yeast infections. Econazole nitrate, a topical antifungal, is used to treat tinea versicolor, tinea pedis, and tinea cruris. Compared to applying cream or ointment, topical gels offer numerous advantages, one of which is that the drug is released more quickly to the intended site of action. A viscous mixture of propylene glycol, Capmul MCM C8, methyl and propyl paraben, and econazole nitrate were mixed together before being formulated into the optimized Carbopol gel bases. The gel's color, appearance, and homogeneity were assessed visually. For every formulation, the drug content, pH, viscosity, spreadability, and gel strength were characterized. The cup plate diffusion method was used to evaluate the anti-fungal activity of the prepared formulations. To assess the behavior of the developed system, studies on in vitro release and mechanism were conducted. The manufactured formulations were transparent, pale yellow, and exhibited excellent homogeneity. The pH of each formulation was roughly 6.0, making them suitable for topical use. The concentration of Carbopol 940 resulted in a significant increase in viscosity and gel strength but a significant decrease in spreadability. It was demonstrated that the prepared formulations inhibited the growth of and . In contrast, the standard blank gel showed no signs of antifungal action. By increasing the concentration of Carbopol 940, the in vitro release profile of econazole nitrate significantly decreased. Following the Korsmeyer-Peppas model fitting, all formulations exhibited n values greater than 0.5 and less than 1, indicating that diffusion and gel swelling control econazole nitrate release.
PubMed: 38131915
DOI: 10.3390/gels9120929 -
Turkish Journal of Pharmaceutical... Oct 2021Combinatorial drugs are among the leading pharmacotherapeutic agents, including those used for the treatment of herpetic infections, which require complex treatment. We...
OBJECTIVES
Combinatorial drugs are among the leading pharmacotherapeutic agents, including those used for the treatment of herpetic infections, which require complex treatment. We have developed a soft dosage form of ointment, which includes acyclovir and miramistin, which have antimicrobial, anti-inflammatory, and local immunoadjuvant activity. The study aimed to investigate the rheological properties of ointment bases in order to substantiate the composition of a soft dosage form with antiviral effect using the active ingredients miramistin and acyclovir.
MATERIALS AND METHODS
The object of the study was to determine the heterogeneous and homogeneous composition models of the bases made using a wide range of excipients. Structural and mechanical studies were performed using the "Rheolab QC" rotary viscometer by Anton Paar (Austria) with coaxial cylinders CC27/S-SN29766. The rheological parameters were investigated at a temperature of 25°C±0.5°C. The samples were thermostated using a thermostat MLM U15c. The batch of sample weighing about 15.0±0.5 g was placed in the container of an external stationary cylinder. The required temperature of the experiment was set and the thermostating time was 20 min. The device is equipped with RheoPlus 32 V3.62 software.
RESULTS
The rheological behavior of the model compositions was analyzed in terms of indicators, such as yield strength, hysteresis square, coefficients of dynamic flow, and mechanical stability. It was found that all samples have a non-Newtonian pseudoplastic type of flow. The model of spreading optimums was used to evaluate consumer properties. According to the rheological parameters, it is advisable to use the sample based on paraffin and vaseline oil for further research.
CONCLUSION
The findings from this study will be relevant in the development of the soft dosage form for the treatment of herpes viral diseases.
PubMed: 34719191
DOI: 10.4274/tjps.galenos.2021.93457 -
The Cochrane Database of Systematic... Dec 2017Cutaneous leishmaniasis, caused by a parasitic infection, is considered one of the most serious skin diseases in many low- and middle-income countries. Old World... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cutaneous leishmaniasis, caused by a parasitic infection, is considered one of the most serious skin diseases in many low- and middle-income countries. Old World cutaneous leishmaniasis (OWCL) is caused by species found in Africa, Asia, the Middle East, the Mediterranean, and India. The most commonly prescribed treatments are antimonials, but other drugs have been used with varying success. As OWCL tends to heal spontaneously, it is necessary to justify the use of systemic and topical treatments. This is an update of a Cochrane Review first published in 2008.
OBJECTIVES
To assess the effects of therapeutic interventions for the localised form of Old World cutaneous leishmaniasis.
SEARCH METHODS
We updated our searches of the following databases to November 2016: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs). We wrote to national programme managers, general co-ordinators, directors, clinicians, WHO-EMRO regional officers of endemic countries, pharmaceutical companies, tropical medicine centres, and authors of relevant papers for further information about relevant unpublished and ongoing trials. We undertook a separate search for adverse effects of interventions for Old World cutaneous leishmaniasis in September 2015 using MEDLINE.
SELECTION CRITERIA
Randomised controlled trials of either single or combination treatments in immunocompetent people with OWCL confirmed by smear, histology, culture, or polymerase chain reaction. The comparators were either no treatment, placebo/vehicle, and/or another active compound.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias and extracted data. We only synthesised data when we were able to identify at least two studies investigating similar treatments and reporting data amenable to pooling. We also recorded data about adverse effects from the corresponding search.
MAIN RESULTS
We included 89 studies (of which 40 were new to this update) in 10,583 people with OWCL. The studies included were conducted mainly in the Far or Middle East at regional hospitals, local healthcare clinics, and skin disease research centres. Women accounted for 41.5% of the participants (range: 23% to 80%). The overall mean age of participants was 25 years (range 12 to 56). Most studies lasted between two to six months, with the longest lasting two years; average duration was four months. Most studies were at unclear or high risk for most bias domains. A lack of blinding and reporting bias were present in almost 40% of studies. Two trials were at low risk of bias for all domains. Trials reported the causative species poorly.Here we provide results for the two main comparisons identified: itraconazole (200 mg for six to eight weeks) versus placebo; and paromomycin ointment (15% plus 10% urea, twice daily for 14 days) versus vehicle.In the comparison of oral itraconazole versus placebo, at 2.5 months' follow up, 85/125 participants in the itraconazole group achieved complete cure compared to 54/119 in the placebo group (RR 3.70, 95% CI 0.35 to 38.99; 3 studies; 244 participants). In one study, microbiological or histopathological cure of skin lesions only occurred in the itraconazole group after a mean follow-up of 2.5 months (RR 17.00, 95% CI 0.47 to 612.21; 20 participants). However, although the analyses favour oral itraconazole for these outcomes, we cannot be confident in the results due to the very low certainty evidence. More side effects of mild abdominal pain and nausea (RR 2.36, 95% CI 0.74 to 7.47; 3 studies; 204 participants) and mild abnormal liver function (RR 3.08, 95% CI 0.53 to 17.98; 3 studies; 84 participants) occurred in the itraconazole group (as well as reports of headaches and dizziness), compared with the placebo group, but again we rated the certainty of evidence as very low so are unsure of the results.When comparing paromomycin with vehicle, there was no difference in the number of participants who achieved complete cure (RR of 1.00, 95% CI 0.86, 1.17; 383 participants, 2 studies) and microbiological or histopathological cure of skin lesions after a mean follow-up of 2.5 months (RR 1.03, CI 0.88 to 1.20; 383 participants, 2 studies), but the paromomycin group had more skin/local reactions (such as inflammation, vesiculation, pain, redness, or itch) (RR 1.42, 95% CI 0.67 to 3.01; 4 studies; 713 participants). For all of these outcomes, the certainty of evidence was very low, meaning we are unsure about these results.Trial authors did not report the percentage of lesions cured after the end of treatment or speed of healing for either of these key comparisons.
AUTHORS' CONCLUSIONS
There was very low-certainty evidence to support the effectiveness of itraconazole and paromomycin ointment for OWCL in terms of cure (i.e. microbiological or histopathological cure and percentage of participants completely cured). Both of these interventions incited more adverse effects, which were mild in nature, than their comparisons, but we could draw no conclusions regarding safety due to the very low certainty of the evidence for this outcome.We downgraded the key outcomes in these two comparisons due to high risk of bias, inconsistency between the results, and imprecision. There is a need for large, well-designed international studies that evaluate long-term effects of current therapies and enable a reliable conclusion about treatments. Future trials should specify the species of leishmaniasis; trials on types caused by Leishmania infantum, L aethiopica, andL donovani are lacking. Research into the effects of treating women of childbearing age, children, people with comorbid conditions, and those who are immunocompromised would also be helpful.It was difficult to evaluate the overall efficacy of any of the numerous treatments due to the variable treatment regimens examined and because RCTs evaluated different Leishmania species and took place in different geographical areas. Some outcomes we looked for but did not find were degree of functional and aesthetic impairment, change in ability to detect Leishmania, quality of life, and emergence of resistance. There were only limited data on prevention of scarring.
Topics: Adult; Animals; Anti-Infective Agents; Antiprotozoal Agents; Complementary Therapies; Cryotherapy; Asia, Eastern; Female; Hot Temperature; Humans; Itraconazole; Laser Therapy; Leishmania major; Leishmania tropica; Leishmaniasis, Cutaneous; Male; Middle Aged; Middle East; Ointment Bases; Paromomycin; Photochemotherapy; Randomized Controlled Trials as Topic
PubMed: 29192424
DOI: 10.1002/14651858.CD005067.pub5 -
International Dental Journal Oct 2022The aim of this work was to review the protocol of the use of silver diamine fluoride (SDF) for arresting caries, specifically the application time. (Review)
Review
OBJECTIVE
The aim of this work was to review the protocol of the use of silver diamine fluoride (SDF) for arresting caries, specifically the application time.
METHOD
Two researchers searched manufacturers' instructions, YouTube videos, and 5 databases (Embase, Medline, PubMed, Scopus, and Web of Science). Manufacturers' instructions, videos from national dental organisations, and peer-reviewed journal articles that published the SDF application protocol in English for arresting caries were selected.
RESULTS
The review included 14 protocols from 15 publications from 4 manufacturers, 3 dental associations, and 7 author teams (one team had 2 articles). The American Dental Association and the British Society of Paediatric Dentistry provided their SDF application protocols on YouTube. The American Academy of Paediatric Dentistry and 7 author teams published their protocols in journal articles. Seven publications suggested an SDF application time of 60 seconds. Seven publications suggested a time range of 10 seconds to 240 seconds. Two publications suggested caries excavation, but 4 publications suggested no caries excavation before SDF application. The procedures from at least 5 publications involved protecting the gingiva with petroleum jelly, isolating the carious tooth with cotton rolls, drying the carious lesion with a 3-in-1 syringe, applying SDF solution with a micro brush for 60 seconds, removing excess SDF solution with gauze, and applying fluoride varnish to the SDF-treated lesion.
CONCLUSIONS
Although the SDF application protocol is simple and straightforward, the published protocols could be different. Most publications suggested an SDF application time of 60 seconds, which can be long, particularly for young children and older adults.
Topics: Aged; Cariostatic Agents; Child; Child, Preschool; Dental Caries; Fluorides, Topical; Humans; Petrolatum; Quaternary Ammonium Compounds; Silver Compounds
PubMed: 35843730
DOI: 10.1016/j.identj.2022.06.006