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High‐dose betamethasone and dexamethasone are standard of care treatments for women at risk of preterm delivery to improve neonatal respiratory and mortality outcomes. The dose in current use has never been evaluated to minimize exposures while assuring efficacy. We report the pharmacokinetics and pharmacodynamics (PDs) of oral and intramuscular treatments with single 6 mg doses of dexamethasone phosphate, betamethasone phosphate, or a 1:1 mixture of betamethasone phosphate and betamethasone acetate in reproductive age South Asian women. Intramuscular or oral betamethasone has a terminal half‐life of 11 hours, about twice as long as the 5.5 hours for oral and intramuscular dexamethasone. The 1:1 mixture of betamethasone phosphate and betamethasone acetate shows an immediate release of betamethasone followed by a slow release where plasma betamethasone can be measured out to 14 days after the single dose administration, likely from a depo formed at the injection site by the acetate. PD responses were: increased glucose, suppressed cortisol, increased neutrophils, and suppressed basophils, CD3CD4 and CD3CD8 lymphocytes. PD responses were comparable for betamethasone and dexamethasone, but with longer times to return to baseline for betamethasone. The 1:1 mixture of betamethasone phosphate and betamethasone acetate caused much longer adrenal suppression because of the slow release. These results will guide the development of better treatment strategies to minimize fetal and maternal drug exposures for women at risk of preterm delivery.

IntroductionAntenatal corticosteroid (ACS) regimens have remained unchanged since the initial trials in 1972, with the optimal regimen still undetermined. The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns)-III trial is a three-arm individually randomised double-blind trial evaluating the efficacy and safety of two different ACS dosing regimens (currently used and lower-dose ACS regimens vs placebo) in women with a high probability of having a late preterm birth. This study protocol nested within this trial aims to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) effects of two different ACS dosing regimens in pregnant women in the late preterm period (34–36 weeks) to help inform an optimal dosing regimen.Methods and analysisThe study will be conducted in two of the five countries participating in the WHO ACTION-III trial—India (Delhi, Belagavi) and Nigeria (Ibadan and Ile-Ife). We will use a population PK approach using sparse sampling to study the PK effects of the two ACS regimens, that is, 6 mg dexamethasone phosphate (DEXp) or 2 mg betamethasone phosphate (BETp), administered intramuscularly every 12 hours for a maximum of four doses or till birth, whichever is earlier, compared with placebo. We will also ascertain the fetal–maternal ratio of DEXp and BETp at birth.Maternal venous blood samples will be collected at 0, 1–4 hours, 8–12 hours after the first dose, and at 24–36 hours, 48–60 hours, 72–96 hours after the last dose, and immediately after birth, along with cord blood. Concentrations of DEXp and BETp will be measured at set time points using a validated liquid chromatography mass spectroscopy assay. PD parameters measured will include total and differential white blood cell count (by automated analysers using electrical impedance), plasma glucose (hexokinase method) and serum cortisol (using a validated electrochemiluminescence immunoassay), at predefined time points. PK models will be developed for each drug using non-linear mixed effects methods. Optimal dosing will be investigated using Monte Carlo simulations.Ethics and disseminationThe study has been approved by the WHO Ethics Review Committee and the site-specific ethics committees of the participating leading institutions. Written informed consent will be obtained from all participants. The study results will be published in a peer-reviewed journal and presented at scientific conferences.Trial registration numberISRCTN11434567.

To evaluate the effectiveness of non-aromatic very rich in steranes (NAVS) naphthalan in the treatment of oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Null hypothesis was that there would be no difference between NAVS and topical steroids in the treatment of OLP and RAS. The study consisted of two sub-trials conducted as randomized, double-blind controlled studies: first included OLP patients and second patients with RAS. Patients received either NAVS or 0.05% betamethasone dipropionate. Primary outcomes were activity score (OLP patients), No of lesions and lesion diameter (RAS patients) and pain intensity (VAS) while secondary outcome included the impact of the disease on quality of life assessed by Oral health impact profile (OHIP 14). No significant differences in terms of OLP clinical signs (p = 0.84, η2 = 0.001) and responses on the OHIP-14 (p = 0.81, η2 = 0.002) or on VAS (p = 0.14, η2 = 0.079) between NAVS and betamethasone groups were observed. In RAS patients, no significant differences between the groups in terms of lesion number (at days 3 and 5, p = 0.33 and p = 0.98, respectively), lesion diameter (days 3 and 5, p = 0.24 and p = 0.84, respectively) were observed. However, in NAVS group a significant reduction of lesions diameter was observed on the 3rd day, while in betamethasone group a significant reduction in lesions diameter was evident only after the 5th day. No significant differences in VAS (p > 0.05) and the OHIP-14 (p > 0.05) between groups were found. No evidence of differences between the two compared interventions was found. Retrospective registration of this trial was conducted in ClinicalTrials.gov on September 30, 2016; trial registration number: NCT02920658. https://clinicaltrials.gov/ct2/show/NCT02920658?term=NAVS&draw=2&rank=4.

In this multicenter, randomized trial involving women at high risk for late preterm delivery, administration of betamethasone significantly reduced the rate of neonatal respiratory complications. Antenatal glucocorticoids are widely used in obstetrics for pregnancies at risk for early preterm delivery. Their use increased especially after a consensus conference held by the National Institutes of Health in 1994, which concluded that there was strong evidence that glucocorticoids reduce adverse neonatal outcomes, including death, the respiratory distress syndrome, and other complications, when administered to women who are likely to deliver before 34 weeks of gestation. 1 – 3 The recommendation was not extended to women at risk for preterm delivery after 34 weeks because of both a lack of data 4 , 5 and the belief that at a threshold of . . .

Excimer light was reported to be effective in treating alopecia areata (AA), as it induces T-cell apoptosis, however its combination with topical steroids in the management of AA still needs to be investigated. The study objectives were to determine the efficacy and safety of combining 308 nm–Excimer light and topical steroid versus either Excimer light or topical steroid alone in treating AA. Thirty AA patients were included, each patient had at least three patches, patches in each patient were randomly classified in to 3 groups. Group I patch: was treated by topical steroid only. Group II patch: was treated by Excimer light only. Group III patch: was treated by topical steroid and Excimer light. The response for hair growth was assessed at the baseline, week 8, week 12 then at 3months after the last session using a hair regrowth scale and trichoscopy. Any encountered adverse effects were recorded. All treatment groups showed significant improvement at the end of the study compared to the baseline, although hair regrowth was significantly better in group III where 60% of patches showed > 50% hair regrowth. All treatment groups showed significant decrease in black dots (BD) (trichoscopic sign of activity), and increase in signs of improvement (upright growing and pigtail hairs). However, BD and exclamation mark hair (EMH) were significantly reduced in the mixed therapy group compared to the other two groups. We concluded that excimer light is an effective and safe treatment option for AA, particularly when combined with topical steroid.

Clinical practice guidelines recommend administering antenatal corticosteroids (ACS), either betamethasone or dexamethasone, to women at risk of preterm birth at less than 35 weeks' gestation. If women remain at risk of preterm birth seven or more days after an initial course of ACS, most guidelines recommend administration of a repeat dose(s). No randomised trials have assessed the efficacy of dexamethasone as a repeat steroid compared to betamethasone. We aimed to determine if there were differences between the use of dexamethasone or betamethasone as repeat ACS, for women who remain at risk of preterm birth after an initial course, on maternal, infant, and childhood health outcomes. We performed a secondary analysis of data from the ASTEROID randomised trial, where women at risk of preterm birth were allocated to either betamethasone or dexamethasone. Infant, childhood, and maternal outcomes were compared according to whether women received a repeat dose(s) of dexamethasone or betamethasone. The primary outcome was a composite outcome of death or any neurosensory disability at age two years (corrected for prematurity). The ASTEROID trial is registered with ANZCTR, ACTRN12608000631303. 168 women and their infants were included, with 86 women receiving dexamethasone and 82 women receiving betamethasone as a repeat dose. Women in the two ACS groups had similar baseline characteristics. We observed little to no difference in the incidence of death or any neurosensory disability at age two years (OR 0.89, 95% CI 0.39 to 2.06, p = 0.79) or in the incidence of other infant, childhood, and maternal adverse health outcomes between women who received dexamethasone and those who received betamethasone. Use of dexamethasone for a repeat dose(s) compared to betamethasone did not result in any differences in infant, childhood, and maternal health outcomes. These results can be used to support clinical practice guideline recommendations.

BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. METHODSThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. RESULTSThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRSpain reduction 50% or greater74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. CONCLUSIONSThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.Clinical Trial RegistrationClinicalTrials.gov (NCT02343003).

Introduction Erosive oral lichen planus (OLP) and periodontitis frequently coexist and may worsen each other. This study will evaluate the effectiveness and safety of combining periodontal initial therapy under local anesthesia with intralesional betamethasone sodium phosphate (BSP) injection in patients with erosive OLP, particularly in enhancing lesion healing. Methods and analysis This is a multicenter, randomized, split-mouth, self-controlled trial. We will recruit 29 adults from five tertiary centers in China. Eligible participants are adults (aged ≥ 18 years) diagnosed with erosive gingival OLP accompanied by generalized periodontitis (stage II–IV). Within each participant, sides will be randomly allocated to a test side (periodontal initial therapy under local anesthesia plus intralesional BSP) and a control side (intralesional BSP alone). Independent outcome assessors and statisticians will be strictly blinded to ensure objectivity of the assessments. The follow-up will last 6 months, with assessments at the 2nd, 4th, 8th, 12th, and 24th weeks. The primary outcome is the reduction in erosive lesion size at the 12th week. Secondary outcomes will include the complete healing rate, OLP clinical severity scores, visual analog score of pain, periodontal parameters, and complications. Discussion This protocol introduces an innovative method for managing erosive OLP accompanied by periodontitis by integrating periodontal initial therapy under local anesthesia with corticosteroid injections. It aims to offer a more effective and patient-centric multidisciplinary treatment strategy. The utilization of local anesthetics will enhance patient comfort and optimize adherence. Findings will guide clinical practice and motivate mechanistic studies. Trial registration The trial has been registered on the Chinese Clinical Trial Registry (No. ChiCTR2400083728; registered on April 30, 2024) and on the U.S. National Institutes of Health Clinical Trials website (No. NCT06498180; registered on July 12, 2024). Protocol version: 1.0 Version date: 01 September 2025.

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.

To explore the anesthetic efficacy of ropivacaine combined with compound betamethasone in iliac fascial space nerve block analgesia (IFNBA) in patients receiving artificial femoral head replacement (AFHR), and to provide a theoretical basis for the selection of clinical anesthetic drugs. From January 2022 to June 2022, 70 patients requiring IFNBA analgesia undergoing AFHR surgery at our hospital were included in this prospective study. Using Excel randomization, 70 patients were divided into study group ( n  = 35) and control group ( n  = 35). The study group received ropivacaine combined with compound betamethasone analgesia regimen, while the control group only received ropivacaine analgesia regimen. In addition to patients’ general baseline clinical characteristics, outcomes indicators included preoperative and postoperative visual analogue scale (VAS) pain scores, preoperative and postoperative Ramsay sedation scores, preoperative and postoperative levels of inflammatory cytokines, duration of analgesia and patient satisfaction in both groups were collected. At 12 h and 24 h after surgery, the static and dynamic VAS pain score of the study group was significantly lower than that of the control group ( P  < 0.05). At 6 h and 12 h after surgery, the Ramsay sedation score of the study group was significantly higher than that of the control group ( P  < 0.05). The level of inflammatory cytokines in the study group was significantly lower than that in the control group at the completion of surgery, 24 h and 72 h after surgery ( P  < 0.05). In addition, the study group had a significantly longer duration of postoperative analgesia and significantly better patient satisfaction ( P  < 0.05). Especially for patients receiving AFHR, in IFNBA, ropivacaine combined with compound betamethasone has better analgesic effect, higher patient satisfaction, and can effectively reduce the level of inflammatory status, which is worthy of clinical application and promotion.