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The tubulin polymerization and Src kinase inhibitor tirbanibulin was superior to placebo ointment in clearing actinic keratoses on the face and scalp at 2 months. As is typical of the disorder, lesions recurred in 47% of patients at 1 year. Adverse events were related to local irritation.

Background. Topical antimicrobial therapy of infected diabetic foot ulcers can focus on the wound and avoid the adverse effects of systemic anti-infective agents. We compared the efficacy of outpatient treatment using an investigational topical antimicrobial peptide, pexiganan acetate cream, with the efficacy of systemic therapy using an oral fluoroquinolone antibiotic, ofloxacin, for mildly infected diabetic foot ulcers. Methods. In 2 consecutive, double-blind, controlled trials (study 303 and study 304), we randomized diabetic patients with a mildly infected diabetic foot ulcer to receive the active topical agent or active oral antibiotic, plus a respective inactive placebo. The primary outcome of interest was clinical cure or improvement of the infection. Secondary outcomes included eradication of wound pathogens and wound healing, which was documented by a semiquantitative scoring system. Results. Overall, 835 patients were randomized; those in each treatment arm were similar with regard to demographic and clinical characteristics. Although study 303 failed to demonstrate equivalence, study 304 and the combined data for the 2 trials demonstrated equivalent results (within the 95% confidence interval) for topical pexiganan and oral ofloxacin in clinical improvement rates (85%–90%), overall microbiological eradication rates (42%–47%), and wound healing rates. The incidence of worsening cellulitis (2%–4%) and amputation (2%–3%) did not differ significantly between treatment arms. Bacterial resistance to ofloxacin emerged in some patients who received ofloxacin, but no significant resistance to pexiganan emerged among patients who received pexiganan. Conclusions. Topical pexiganan might be an effective alternative to oral antibiotic therapy in treating diabetic patients with a mildly infected foot ulcer, and might reduce the risk of selecting antimicrobial-resistant bacteria. Clinical trials registration. NCT00563394 and NCT00563433.

Jaft extract exhibits anti-inflammatory, antimicrobial, antioxidant, and astringent properties, making it a promising therapeutic agent for wound treatment. This study aims to synthesize an the ointment containing varying concentrations of Jaft extract and evaluate its efficacy in promoting wound healing. By understanding that prompt wound washing prevents infection and acts as an astringent, we observe its dual role in achieving hemostasis and controlling bleeding. The second aim is to assess the impact of early wound cleansing with Jaft extract on treatment outcomes. A comparative study was conducted to evaluate the impact of preliminary wound washing with Jaft extract before ointment application on healing efficacy. Three ointment formulations (2%, 4%, and 8% w/w Jaft extract) were prepared. Wound healing parameters in rats included wound closure rate, levels of catalase and glutathione antioxidants, histopathological analysis, hydroxyproline content, and tissue-breaking strength. The Jaft extract exhibited potent antioxidant (3.72 μg/mL) and anti-inflammatory (IC 50 of NO inhibition: 0.0045 mg/mL) properties, attributed to its high tannin and flavonoid content. In vivo studies demonstrated that pre-treatment with Jaft extract followed by 2% w/w ointment application resulted in the most rapid wound closure (87% by day 7) and optimal tissue regeneration in male Wistar rats.

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.

PurposeThis comprehensive prospective study aimed to investigate the bacterial contamination of antibiotic steroid eye ointments and drops frequently used by eye patients.MethodIn this comprehensive prospective study, a total of 410 multi-use topical eye medications containing 15 different ingredients from 22 pharmaceutical companies used by 185 patients were analyzed. Four groups were formed as follows: group 1: antibiotic ointments (n: 109); group 2: antibiotic drops (n: 103); group 3: steroid ointments (n: 67); and group 4: steroid drops (n: 131). Topical multi-use eye drops and ointments used by patients at home for at least 1 week were randomly collected. The caps and contents were separately bacteriologically examined in a chocolate agar medium.ResultsOur study detected bacterial contamination in 23 containers (5.6%) of the total 410 topical drugs. According to the groups, bacterial contamination was detected in 10 of 67 (14.9%) steroid ointments, 6 of 109 (5.5%) antibiotic ointments, 4 of 131(3.1%) steroid drops, and 3 of 103 (2.9%) antibiotic drops. While the bacterial contamination rate in ointments was 9.1%, this rate was 3% in drops. The difference between them was statistically significant (p = 0.015). According to the post-hoc pairwise comparisons, the difference between steroid drops and steroid ointment (p = 0.0023) was statistically significant. Among all drugs, contamination was detected in 12 of the 93 (12.9%) containers used after keratitis, conjunctivitis, and inflammatory conditions. It was determined that preservatives statistically reduced bacterial growth on the cap. The preservatives did not have a statistically significant effect on the bacterial contamination of the contents compared to the caps. While all contaminations were detected in illiterate and primary school graduates, no contamination was seen in the drugs used by any secondary school or university graduate.ConclusionOur study detected contamination in all topical ophthalmic drug groups. Contamination rates were found to be higher in ointments and steroids. Bacterial contamination was also seen in drugs containing preservatives. We should be careful in the use of topical medications. We do not recommend the bilateral use of ointments and drops in infected eyes, such as those with keratitis, or after intraocular surgeries, such as those for cataracts.

Alopecia areata/AA is an autoimmune cause of nonscarring hair loss. The pathogenesis of AA involves many immune axes, including Th1/Th2 pathways. Delgocitinib is a pan-Janus kinase/JAK inhibitor that broadly blocks pro-inflammatory cytokines and has been effective in other inflammatory skin conditions. Recent human studies/reports have shown that use of some systemic JAK inhibitors led to hair regrowth, suggesting this medication class as a potential therapy for AA. However, topical treatment is desirable due to potential systemic side effects. To assess the efficacy and safety of topical delgocitinib in AA, we conducted a double-blind, randomized, vehicle-controlled clinical trial in 31 moderate-to-severe AA patients that were randomized 2:1 to receive delgocitinib ointment 30 mg/g ( n  = 20) or ointment vehicle ( n  = 11) for 12 weeks. The primary endpoint was change in severity of Alopecia Tool/SALT score from baseline to week 12. The secondary endpoint included safety profile by reported adverse events. Twenty-three subjects completed the trial, with eight discontinuing mostly due to voluntary withdrawal. Ten patients receiving delgocitinib ointment and three patients receiving vehicle showed SALT score improvements after 12 weeks, but the mean percent SALT improvement at week 12 compared to baseline between the two arms was not significant ( p  = 0.92). Our study suggests that delgocitinib ointment is not effective in moderate-to-severe AA, likely due to its inability to penetrate sufficiently deeply into the dermis of the scalp, but larger studies are necessary to assess whether a different formulation of topical JAK inhibitors may be suitable to treat mild or more localized forms of AA.

The healthcare workforce in the United States is becoming increasingly diverse, gradually shifting society away from the historical overrepresentation of White men among physicians. However, given the long-standing underrepresentation of people of color and women in the medical field, patients may still associate the concept of doctors with White men and may be physiologically less responsive to treatment administered by providers from other backgrounds. To investigate this, we varied the race and gender of the provider from which White patients received identical treatment for allergic reactions and measured patients’ improvement in response to this treatment, thus isolating how a provider’s demographic characteristics shape physical responses to healthcare. A total of 187 White patients experiencing a laboratory-induced allergic reaction interacted with a healthcare provider who applied a treatment cream and told them it would relieve their allergic reaction. Unbeknownst to the patients, the cream was inert (an unscented lotion) and interactions were completely standardized except for the provider’s race and gender. Patients were randomly assigned to interact with a provider who was a man or a woman and Asian, Black, or White. A fully blinded research assistant measured the change in the size of patients’ allergic reaction after cream administration. Results indicated that White patients showed a weaker response to the standardized treatment over time when it was administered by women or Black providers. We explore several potential explanations for these varied physiological treatment responses and discuss the implications of problematic race and gender dynamics that can endure “under the skin,” even for those who aim to be bias free.

The indications for collagenase ointment (CO) and its efficacy are not clearly established in the treatment of second-degree burn wounds. To evaluate the efficacy of CO versus silver sulfadiazine ointment (SSD) in the treatment of second-degree burn wounds. A total of 170 eligible patients with deep second-degree burns, aged 18–65 years, with injuries occurring within 48–96 h, and having a total wound area of less than 30% of the total body surface area were included from 5 centers in China. The primary outcome was the wound healing time, and the secondary outcomes were the clearance time of wound necrotic tissues, wound healing rate, and wound inflammation. The study included 85 patients in SSD group and 84 in CO group in the modified intention-to-treat (mITT) population. The median time of wound healing was comparable in both groups (10 days vs. 10.5 days P  = 0.16). The time for wound necrotic tissue removal was significantly shortened by CO compared with SSD (5 vs. 10 days P  < 0.01). Wound inflammation, pain, wound healing rate, and scar were compared with SSD (all P-values > 0.05). No adverse events, such as infection or allergic reactions to the drugs and materials used, were reported. Both CO and SSD could heal the burn wounds at 10 days of treatment. However, CO significantly shortened the time of wound necrotic tissue removal by 5 days. Trial Registration: ChiCTR2100046971.

Background and Objective The antipsoriatic effect of an innovative aerosol foam formulation of fixed combination calcipotriol 50 μg/g (as hydrate; Cal) and betamethasone 0.5 mg/g (as dipropionate; BD) was explored in order to compare the effect with that of the first-line treatment Cal/BD ointment. Methods This was a Phase IIa, single-centre, investigator-blinded, exploratory study, with intra-individual comparison using a modified psoriasis plaque test. Patients were treated once daily (6 days/week) for 4 weeks with Cal/BD foam, Cal/BD ointment, BD foam and Cal/BD foam vehicle, randomized to four plaque test sites (5 cm 2 each). The primary efficacy endpoint was change in total clinical score (TCS; sum of erythema, scaling and lesional thickness). Secondary endpoints included ultrasonographic changes in total skin thickness and echo-poor band thickness, and adverse events. Results Twenty-four patients, median age 52.5 years (range 21–75), completed this study. At week 4, test sites treated with Cal/BD foam had a significantly greater decrease in mean (±SD) TCS (−6.00 ± 1.27) versus those treated with Cal/BD ointment (−5.25 ± 1.78; difference −0.75; 95 % CI −1.46 to −0.04; p  = 0.038), BD foam (−4.96 ± 1.85; difference −1.04; 95 % CI −1.75 to −0.33; p  = 0.005) or foam vehicle (−1.88 ± 1.12; difference −4.13; 95 % CI −4.83 to −3.42; p  < 0.001). Total skin thickness and echo-poor band thickness of Cal/BD foam-treated sites were reduced to a greater extent than those treated with comparators. Eleven patients reported 17 adverse events, the most frequent being headache (five patients). There were no lesional/perilesional adverse events or adverse drug-related events. Conclusions Cal/BD foam demonstrated a significant improvement in antipsoriatic effect over Cal/BD ointment, BD foam and foam vehicle alone.

This paper reports on a validated, stability-indicating high-performance thin-layer chromatography (HPTLC)-based assay for the quantification of nitrofurazone in an ointment formulation. The simple and rapid HPTLC analysis was performed on silica gel 60 F254 HPTLC plates using toluene–acetonitrile–ethyl acetate–glacial acetic acid (6:2:2:0.1, v/v) as the mobile phase and chloroform–acetone (9:1, v/v) as the solvent. The method was validated in accordance with the guidelines set by both the International Council for Harmonisation (ICH) and the United States Food and Drug Administration (FDA). Nitrofurazone appeared as a sharp band with a RF value of 0.18. The method showed excellent linear regression between the concentration ranges of 30–180 ng/band (R = 99.99%). The limit of detection was found to be 10.39 ng/band, and the limit of quantification was 31.49 ng/band. The forced degradation of nitrofurazone via photolysis, oxidation, acid and alkaline hydrolyses confirmed the assay’s suitability for stability studies involving nitrofurazone. Therefore, the method is considered suitable for the routine quality control of nitrofurazone ointment.