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The Cochrane Database of Systematic... Sep 2014Until recently, phimosis has been treated surgically by circumcision or prepuceplasty; however, recent reports of non-invasive treatment using topical corticosteroids... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Until recently, phimosis has been treated surgically by circumcision or prepuceplasty; however, recent reports of non-invasive treatment using topical corticosteroids applied for four to eight weeks have been favourable. The efficacy and safety of topical corticosteroids for treating phimosis in boys has not been previously systematically reviewed.
OBJECTIVES
We aimed to 1) compare the effectiveness of the use of topical corticosteroid ointment applied to the distal stenotic portion of the prepuce in the resolution of phimosis in boys compared with the use of placebo or no treatment, and 2) determine the rate of partial resolution (improvement) of phimosis, rate of re-stenosis after initial resolution or improvement of phimosis, and the rate of adverse events of topical corticosteroid treatment in boys with phimosis.
SEARCH METHODS
We searched the Cochrane Renal Group's Specialised Register through contact with the Trials' Search Co-ordinator using search terms relevant to this review. Date of last search: 16 June 2014.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) that compared use of any topical corticosteroid ointment with placebo ointment or no treatment for boys with phimosis.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed titles, abstracts and the full-text of eligible studies, extracted data relating to the review's primary and secondary outcomes, and assessed studies' risk of bias. Statistical analyses were performed using the random-effects model and results were expressed as risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI). We contacted authors of primary articles asking for details of study design and specific outcome data.
MAIN RESULTS
We included 12 studies that enrolled 1395 boys in this review. We found that both types of corticosteroids investigated and treatment duration varied among studies.Compared with placebo, corticosteroids significantly increased complete or partial clinical resolution of phimosis (12 studies, 1395 participants: RR 2.45, 95% CI 1.84 to 3.26). Our analysis of studies that compared different types of corticosteroids found that these therapies also significantly increased complete clinical resolution of phimosis (8 studies, 858 participants: RR 3.42, 95% CI 2.08 to 5.62). Although nine studies (978 participants) reported that assessment of adverse effects were planned in the study design, these outcomes were not reported.Overall, we found that inadequate reporting made assessing risk of bias challenging in many of the included studies.Selection bias, performance and detection bias was unclear in the majority of the included studies: two studies had adequate sequence generation, none reported allocation concealment; two studies had adequate blinding of participants and personnel and one had high risk of bias; one study blinded outcome assessors. Attrition bias was low in 8/12 studies and reporting bias was unclear in 11 studies and high in one study.
AUTHORS' CONCLUSIONS
Topical corticosteroids offer an effective alternative for treating phimosis in boys. Although sub optimal reporting among the included studies meant that the size of the effect remains uncertain, corticosteroids appear to be a safe, less invasive first-line treatment option before undertaking surgery to correct phimosis in boys.
Topics: Administration, Topical; Adrenal Cortex Hormones; Beclomethasone; Betamethasone; Clobetasol; Glucocorticoids; Humans; Hydrocortisone; Male; Mometasone Furoate; Ointments; Phimosis; Pregnadienediols; Randomized Controlled Trials as Topic; Triamcinolone
PubMed: 25180668
DOI: 10.1002/14651858.CD008973.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 -
PloS One 2023Glycyrrhetinic acid, a drug with anti-inflammatory effects, enhanced the activity of antipsoriatic efficacy. In this research, an ointment with glycyrrhetinic acid was...
Glycyrrhetinic acid, a drug with anti-inflammatory effects, enhanced the activity of antipsoriatic efficacy. In this research, an ointment with glycyrrhetinic acid was prepaired as the major component and several other herbal monomers (astilbin, osthole, and momordin Ic) have antipsoriatic activity as minor components. Then an Imiquimod-induced psoriasis-like mouse model was established and the damaged skin condition of the administered group, the changes in the spleen index and the secretion of inflammatory factors in mouse skin were observed. Calcipotriol ointment was used as a positive control to compare the efficacy. Glycyrrhizic acid compound ointment significantly improved imiquimod-induced psoriasis in mice and reduced the secretion of TNF-α, IL-12, IL-17, and IL-23 in mouse skin, and showed a stronger therapeutic effect than calcipotriol ointment. Calcipotriol ointment did not significantly alleviate imiquimod-induced splenomegaly and did not significantly reduce the expression of IL-17 and IL-23 in mouse skin. Glycyrrhetinic acid compound ointment was more effective than calcipotriol and was dose-dependent in the treatment of imiquimod-induced psoriatic dermatitis in mice. Meanwhile,calcipotriol was not suitable for the treatment of Imiquimod -induced psoriasis-like mice.
Topics: Animals; Mice; Glycyrrhizic Acid; Imiquimod; Interleukin-17; Ointments; Psoriasis; Glycyrrhetinic Acid; Interleukin-23
PubMed: 37643205
DOI: 10.1371/journal.pone.0290637 -
The Annals of Pharmacotherapy Apr 2022Actinic keratoses (AKs) are cutaneous lesions that arise in sun-damaged skin. AKs may transform into squamous cell carcinoma in situ. Tirbanibulin 1% ointment is a new... (Review)
Review
OBJECTIVE
Actinic keratoses (AKs) are cutaneous lesions that arise in sun-damaged skin. AKs may transform into squamous cell carcinoma in situ. Tirbanibulin 1% ointment is a new topical treatment for AKs, recently approved by the Food and Drug Administration.
DATA SOURCES
The PubMed database was searched for articles published from 1960 to March 31, 2021, using the keywords and .
DATA EXTRACTION
Phase 2 and phase 3 clinical trials were reviewed.
DATA SYNTHESIS
In phase 2 clinical trials, 43% of patients treated with tirbanibulin experienced complete clearance by day 57 (43% [95% CI = 32, 54]). Across two phase 3 clinical trials (pooled data), complete (100%) clearance occurred in 49% of patients in tirbanibulin groups and in only 9% of the vehicle groups (difference, 41% points; 95% CI = 35 to 47; < 0.001). Although no comparative studies are available, tirbanibulin is applied for a shorter duration (5 days) compared with diclofenac 3% gel, fluorouracil 5% cream, and imiquimod 3.75% cream. Adverse events were mild and included pruritus, application site pain, and local skin reactions. Systemic adverse events such as necrosis and angioedema, observed with other AK treatments such as fluorouracil and imiquimod, were not observed with tirbanibulin, thus giving tirbanibulin a favorable safety profile.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
Tirbanibulin effectively reduces AK burden and recurrence and has a favorable safety profile with mild adverse events. In comparison, imiquimod, 5-flourouracil, and diclofenac can result in necrosis, angioedema, and arthralgias.
CONCLUSION
With a favorable safety profile and short regimen, tirbanibulin is an efficacious treatment for clinicians to utilize in their treatment toolbox when treating AKs on the face and scalp.
Topics: Acetamides; Humans; Keratosis, Actinic; Morpholines; Ointments; Pyridines; Treatment Outcome; United States
PubMed: 34301153
DOI: 10.1177/10600280211031329 -
Foods (Basel, Switzerland) Dec 2022This study was to investigate the impact of granule size, amylose content, and starch molecular characteristics on pasting and rheological properties of starch...
This study was to investigate the impact of granule size, amylose content, and starch molecular characteristics on pasting and rheological properties of starch paste/gels in neutral (water) and sugar-acid systems. Normal rice starch (RS), waxy rice starch (WRS), normal tapioca starch (TS), and waxy tapioca starch (WTS) representing small-granule starches and intermediate-granule starches respectively, were used in the study. Impacts of granule size, AM content, and their synergistic effects resulted in different starch susceptibility to acid hydrolysis and interactions between starch and sucrose-water, yielding different paste viscosities in both systems. The high molecular weight (Mw¯) and linearity of amylopectin and amylose molecules increased the consistency of starch pastes. RS produced a stronger and more brittle gel than other starch gels in both neutral and sugar-acid systems. The results indicated the impact of the effect of granule size and amylose content on starch gel behaviors. Properties of waxy starch gels were mainly governed by amylopectin molecular characteristics, especially in the sugar-acid system. Adding sugar and acid had minor impacts on starch gel behaviors in the linear viscoelastic (LVE) region but were most evident in the nonlinear response regime of starch gels as shown in the Lissajous curves at large oscillatory strain.
PubMed: 36553803
DOI: 10.3390/foods11244060 -
The Cochrane Database of Systematic... Feb 2017Pressure ulcers are common in clinical practice and pose a significant health problem worldwide. Apart from causing suffering to patients, they also result in longer... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pressure ulcers are common in clinical practice and pose a significant health problem worldwide. Apart from causing suffering to patients, they also result in longer hospital stays and increase the cost of health care. A variety of methods are used for treating pressure ulcers, including pressure relief, patient repositioning, biophysical strategies, nutritional supplementation, debridement, topical negative pressure, and local treatments including dressings, ointments and creams such as bacitracin, silver sulphadiazine, neomycin, and phenytoin. Phenytoin is a drug more commonly used in the treatment of epilepsy, but may play an important role in accelerating ulcer healing.
OBJECTIVES
To assess the effects of topical phenytoin on the rate of healing of pressure ulcers of any grade, in any care setting.
SEARCH METHODS
In September 2016, we searched the following electronic databases to identify relevant randomized clinical trials: the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library); Ovid MEDLINE; Ovid Embase; and EBSCO CINAHL Plus. We handsearched conference proceedings from the European Pressure Ulcer Advisory Panel, European Wound Management Association and the Tissue Viability Society for all available years. We searched the references of the retrieved trials to identify further relevant trials. We also searched clinical trials registries to identify ongoing and unpublished studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included all randomized controlled trials (RCTs) addressing the effects (both benefits and harms) of topical phenytoin on the healing of pressure ulcers of any grade compared with placebo or alternative treatments or no therapy, irrespective of blinding, language, and publication status.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies, extracted information on participants, interventions, methods and results and assessed risk of bias using Cochrane methodological procedures. For dichotomous variables, we calculated the risk ratio (RR) with 95% confidence interval (CI). For continuous variables, we calculated the mean difference with 95% CI. We rated the quality of the evidence by using Grading of Recommendations, Assessment, Development and Evaluation approach (GRADE).
MAIN RESULTS
Three small RCTs met our inclusion criteria and included a total of 148 participants. These compared three treatments with topical phenytoin: hydrocolloid dressings, triple antibiotic ointment and simple dressings. In the three RCTs, 79% of participants had grade II ulcers, and 21% of participants had grade I ulcers; no participants had grade III or IV ulcers. Two RCTs had a high risk of bias overall and the other RCT was at unclear risk of bias due to poor reporting. Two RCTs had three intervention arms and the other had two intervention arms.Two studies compared topical phenytoin with hydrocolloid dressing (84 participants analysed). The available data suggest that hydrocolloid dressings may improve ulcer healing compared to topical phenytoin (39.3% ulcers healed for phenytoin versus 71.4% ulcers healed for hydrocolloid dressings (RR 0.55, 95% CI 0.33 to 0.92; 56 participants, 1 study; low quality evidence). We downgraded the evidence twice: once due to serious limitations (high risk of bias) and once due to the small sample size and small number of events. Two studies compared topical phenytoin with simple dressings (81 participants analysed). From the available data, we are uncertain whether topical phenytoin improves ulcer healing compared to simple dressings (39.3% ulcers healed for phenytoin versus 29.6% ulcers healed for the simple dressing (RR 1.33, 95% CI 0.63 to 2.78; 55 participants, 1 study; very low quality evidence). This evidence was downgraded once due to serious limitations (high risk of bias) and twice due to the low number of outcome events and resulting wide CI which included the possibility of both increased healing and reduced healing. We therefore considered it to be insufficient to determine the effect of topical phenytoin on ulcer healing. One study compared topical phenytoin with triple antibiotic ointment, however, none of the outcomes of interest to this review were reported. No adverse drug reactions or interactions were detected in any of the three RCTs. Minimal pain was reported in all groups in one trial that compared topical phenytoin with hydrocolloid dressings and triple antibiotic ointment.
AUTHORS' CONCLUSIONS
This review has considered the available evidence and the result shows that it is uncertain whether topical phenytoin improves ulcer healing for patients with grade I and II pressure ulcers. No adverse events were reported from three small trials and minimal pain was reported in one trial. Therefore, further rigorous, adequately powered RCTs examining the effects of topical phenytoin for treating pressure ulcers, and to report on adverse events, quality of life and costs are necessary.
Topics: Administration, Topical; Anti-Bacterial Agents; Bandages; Bandages, Hydrocolloid; Dermatologic Agents; Humans; Ointments; Phenytoin; Pressure Ulcer; Randomized Controlled Trials as Topic
PubMed: 28225152
DOI: 10.1002/14651858.CD008251.pub2 -
JAMA Dermatology Sep 2022Given that mycosis fungoides-cutaneous T-cell lymphoma (MF/CTCL) is chronic, there is a need for additional therapies with minimal short- and long-term adverse effects.... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Given that mycosis fungoides-cutaneous T-cell lymphoma (MF/CTCL) is chronic, there is a need for additional therapies with minimal short- and long-term adverse effects. Topical synthetic hypericin ointment, 0.25%, activated with visible light is a novel, nonmutagenic photodynamic therapy (PDT).
OBJECTIVES
To determine the efficacy and safety of topical synthetic hypericin ointment, 0.25%, activated with visible light as a nonmutagenic PDT in early-stage MF/CTCL.
DESIGN, SETTINGS, AND PARTICIPANTS
This was a multicenter, placebo-controlled, double-blinded, phase 3 randomized clinical trial (FLASH study) conducted from December 2015 to November 2020 at 39 academic and community-based US medical centers. Participants were adults (≥18 years) with early-stage (IA-IIA) MF/CTCL.
INTERVENTIONS
In cycle 1, patients were randomized 2:1 to receive hypericin or placebo to 3 index lesions twice weekly for 6 weeks. In cycle 2, all patients received the active drug for 6 weeks to index lesions. In cycle 3 (optional), both index and additional lesions received active drug for 6 weeks.
MAIN OUTCOMES AND MEASURES
The primary end point was index lesion response rate (ILRR), defined as 50% or greater improvement in modified Composite Assessment of Index Lesion Severity (mCAILS) score from baseline after 6 weeks of therapy for cycle 1. For cycles 2 and 3, open label response rates were secondary end points. Adverse events (AEs) were assessed at each treatment visit, after each cycle, and then monthly for 6 months. Data analyses were performed on December 21, 2020.
RESULTS
The study population comprised 169 patients (mean [SD] age, 58.4 [16.0] years; 96 [57.8%] men; 120 [72.3%] White individuals) with early-stage MF/CTCL. After 6 weeks of treatment, hypericin PDT was more effective than placebo (cycle 1 ILRR, 16% vs 4%; P = .04). The ILRR increased to 40% in patients who received 2 cycles of hypericin PDT (P < .001 vs cycle 1 hypericin) and to 49% after 3 cycles (P < .001 vs cycle 1 hypericin). Significant clinical responses were observed in both patch and plaque type lesions and were similar regardless of age, sex, race, stage IA vs IB, time since diagnosis, and number of prior therapies. The most common treatment-related AEs were mild local skin (13.5%-17.3% across cycles 1-3 vs 10.5% for placebo in cycle 1) and application-site reactions (3.2%-6.9% across cycles 1-3 vs 4% for placebo in cycle 1). No drug-related serious AEs occurred.
CONCLUSION AND RELEVANCE
The findings of this randomized clinical trial indicate that synthetic hypericin PDT is effective in early-stage patch and plaque MF/CTCL and has a favorable safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02448381.
Topics: Adult; Anthracenes; Female; Humans; Lymphoma, T-Cell, Cutaneous; Male; Middle Aged; Mycosis Fungoides; Ointments; Perylene; Photochemotherapy; Photosensitizing Agents; Skin Neoplasms; Treatment Outcome
PubMed: 35857290
DOI: 10.1001/jamadermatol.2022.2749 -
American Family Physician Jan 2022
Topics: Administration, Topical; Aged; Dermatitis, Atopic; Eczema; Emollients; Female; Humans; Insect Bites and Stings; Male; Ointments; Physical Examination; Pregnancy; Pruritus; Skin; Tinea; Water
PubMed: 35029961
DOI: No ID Found -
Skin Therapy Letter Mar 2019Atopic dermatitis is a common cutaneous disease with significant morbidity affecting children and adults. The mainstay of atopic dermatitis therapy has typically... (Review)
Review
Atopic dermatitis is a common cutaneous disease with significant morbidity affecting children and adults. The mainstay of atopic dermatitis therapy has typically included emollients, topical corticosteroids, and topical calcineurin inhibitors. Among the newer advances recently introduced is crisaborole (Eucrisa™), a phosphodiesterase type-4 inhibitor (PDE-4) for the treatment of mild moderate atopic dermatitis. Evidence from phase 3 trials demonstrates crisaborole as an efficacious topical agent with a favorable safety profile and limited systemic exposure. While the efficacy of crisaborole compared to existing therapies remains unknown, crisaborole is a promising candidate in the treatment of atopic dermatitis.
Topics: Administration, Cutaneous; Boron Compounds; Bridged Bicyclo Compounds, Heterocyclic; Clinical Trials, Phase III as Topic; Dermatitis, Atopic; Humans; Ointments; Phosphodiesterase 4 Inhibitors
PubMed: 30970204
DOI: No ID Found -
Clinical Therapeutics Jun 2021Impetigo affects approximately 162 million children worldwide at any given time. Lack of consensus on the most effective treatment strategy for impetigo and increasing... (Review)
Review
PURPOSE
Impetigo affects approximately 162 million children worldwide at any given time. Lack of consensus on the most effective treatment strategy for impetigo and increasing antibiotic resistance continue to drive research into newer and alternative treatment options. We conducted a systematic review to assess the effectiveness of new treatments for impetigo in endemic and nonendemic settings.
METHODS
We searched PubMed, MEDLINE, CINAHL, Web of Science, and Embase via Scopus for studies that explored treatments for bullous, nonbullous, primary, and secondary impetigo published between August 1, 2011, and February 29, 2020. We also searched online trial registries and hand-searched the reference lists of the included studies. We used the revised Cochrane risk of bias (version 2.0) tool for randomized trials and the National Heart, Lung, and Blood Institute for nonrandomized uncontrolled studies to assess the risk of bias.
FINDINGS
We included 10 studies that involved 6651 participants and reported on 9 treatments in the final analysis. Most clinical trials targeted nonbullous impetigo or did not specify this. The risk of bias varied among the studies. In nonendemic settings, ozenoxacin 1% cream appeared to have the strongest evidence base compared with retapamulin and a new minocycline formulation. In endemic settings, oral co-trimoxazole and benzathine benzylpenicillin G injection were equally effective in the treatment of severe impetigo. Mass drug administration intervention emerged as a promising public health strategy to reduce the prevalence of impetigo in endemic settings.
IMPLICATIONS
This review highlights the limited research into new drugs used for the treatment of impetigo in endemic and nonendemic settings. Limited recent evidence supports the use of topical ozenoxacin or retapamulin for impetigo treatment in nonendemic settings, whereas systemic antibiotics and the mass drug administration strategy have evidence for use in endemic settings. Given the troubling increase in resistance to existing treatments, there is a clear need to ensure the judicious use of antibiotics and to develop new treatments and alternative strategies; this is particularly important in endemic settings. PROSPERO identifier: CRD42020173042.
Topics: Anti-Bacterial Agents; Child; Humans; Impetigo; Ointments; Treatment Outcome
PubMed: 34053699
DOI: 10.1016/j.clinthera.2021.04.013