Silane-Modified Fillers Enhance Dental Composite Performance, suggests study

Researchers have found in a new study that incorporating filler particles functionalized with silanes containing long alkyl spacers between the silyl and methacrylate groups offers a promising approach for creating packable dental composites. Further these materials demonstrate strong mechanical properties and a significant decrease in viscosity when heated, improving their clinical applicability.

A study was done to evaluate the influence of the nature of silane coupling agents on the consistency of dental composites at various temperatures. Silanes SI 1–4 were synthesized in one single step. They were characterized by 1H and 13C NMR spectroscopy. SI 1–4, as well as 3-methacryloyloxypropyltrimethoxysilane (MPTS), 8-methacryloyloxyoctyltrimethoxysilane (MOTS) and n-dodecyltrimethoxysilane were then used to functionalize a barium aluminum borosilicate glass filler (d50 = 1.0 µm). Silanizations were carried out in cyclohexane in the presence of a catalytic amount of n-propylamine. Each silane was used in an equimolar amount. Composites containing 67 wt% of silanized fillers and packable composites exhibiting a similar consistency at room temperature were subsequently formulated. The consistency of the uncured composites was determined at various temperatures (23 °C, 30 °C, 50 °C and 60 °C) using a texture analyzer. The flexural strength and modulus of the cured composites were assessed according to ISO 4049. Results: The structure of the silane was shown to strongly influence the consistency of composites. The spacer length between silyl and methacrylate groups, as well as the presence of a urea or a urethane moiety, were demonstrated to be key parameters. Heating of each composite resulted in a drop of the consistency. The decrease was however significantly stronger if coupling agents with long spacers were selected. Especially, the use of SI 3 provided a packable composite which exhibited a packable consistency at 30 °C and flowable consistency at 60 °C. Regarding mechanical properties, it was shown that the coupling agent must be able to copolymerize with the monomers of the organic matrix to obtain high flexural strength and modulus values. The silanization of glass fillers using silanes bearing a long spacer was shown to have an additional advantage: packable composites having a higher filler content, and consequently improved flexural modulus, can be formulated. The use of filler particles functionalized with silanes containing long alkyl spacers between the silyl and methacrylate moiety is a promising strategy for the development of packable dental composites which exhibit good mechanical properties and a strong drop in consistency upon heating.

Reference:

Benjamin Grob, Nathan Wachter, Robert Liska, Yohann Catel,

Heating of dental composites: The crucial role of the silane coupling agent on the consistency change, Dental Materials, 2025, ISSN 0109-5641,

https://doi.org/10.1016/j.dental.2025.06.022.

(https://www.sciencedirect.com/science/article/pii/S0109564125006785)

Keywords:

Silane-Modified, Fillers, Enhance, Dental, Composite, Performance, suggest, study, Benjamin Grob, Nathan Wachter, Robert Liska, Yohann Catel, Heating of dental composites

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Matrix rhythm therapy represents promising advancement in treatment of tissue adhesions: study

Matrix rhythm therapy (MRT) is an innovative therapeutic approach that utilizes vibrational and rhythmic stimulation to restore physiological cellular function. Developed by Randoll et al, MRT targets the ECM and cellular rhythm, promoting tissue regeneration and healing. Unlike traditional manual or instrument-assisted techniques, MRT offers a non-invasive solution that acts on both mechanical and physiological levels.

By influencing the ECM directly, MRT helps to reverse the pathological changes that lead to adhesion formation, offering a novel avenue for improving patient outcomes.

MRT demonstrates promising results in breaking tissue adhesions, improving mobility, and reducing pain by restoring cell matrix dynamics and tissue elasticity.

MRT acts on adhesions through several mechanisms – Mechanical disruption, ECM remodeling, Improved microcirculation, Cellular Effects.

Studies and case reports highlight MRT’s efficacy in various conditions.

• Post-surgical adhesions

Patients undergoing MRT post-abdominal or orthopedic surgery report significant improvements in mobility and reductions in pain.

• Chronic pain conditions

In frozen shoulder and myofascial pain syndrome, MRT demonstrated significant pain relief and enhanced range of motion. Clinical trials indicate a 30–50% reduction in pain scores after 4–6 weeks of treatment.

• Athletic recovery

MRT has facilitated faster recovery in athletes by addressing scar tissue and restoring tissue dynamics. Athletes with hamstring or Achilles tendon injuries returned to activity sooner with MRT compared to standard physiotherapy

MRT offers several benefits compared to traditional therapies.

Non-invasive and painless – MRT provides a targeted approach to specific adhesion sites with minimal risk of complications or side effects.

Enhanced patient comfort – The gentle oscillatory mechanism ensures higher patient compliance, particularly in individuals sensitive to pain.

Comprehensive action – By addressing both mechanical and physiological factors, MRT delivers a more holistic approach to tissue healing.

The authors concluded that – ‘Matrix rhythm therapy (MRT) represents a promising advancement in the treatment of tissue adhesions. By addressing the underlying causes of adhesions and promoting ECM remodeling, MRT offers a non-invasive and effective solution for improving mobility and reducing pain. While preliminary evidence supports its efficacy, further research is essential to standardize protocols and establish its role in clinical practice. MRT has the potential to transform adhesion management, providing hope for patients and clinicians alike.’

Further reading:

The role of matrix rhythm therapy in managing and breaking tissue adhesions

International Journal of Research in Orthopaedics

Rizvi A et al. Int J Res Orthop. 2025 May;11(3):671-674 http://www.ijoro.org

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New Gene therapy trial shows restored hearing and speech in children born deaf, treated in both ears

A novel gene therapy designed to target a form of inherited deafness restored hearing function in five children who were treated in both ears. The children also experienced better speech perception and gained the ability to localize and determine the position of sound. The study, the world’s first clinical trial to administer a gene therapy to both ears (bilaterally), demonstrates additional benefits than what were observed in the first phase of this trial, published earlier this year, when children were treated in one ear. The research was led by investigators from Mass Eye and Ear (a member of the Mass General Brigham healthcare system) and Eye & ENT Hospital of Fudan University in Shanghai, and findings were published June 5th in Nature Medicine.

“The results from these studies are astounding,” said study co-senior author Zheng-Yi Chen, DPhil, an associate scientist in the Eaton-Peabody Laboratories at Mass Eye and Ear. “We continue to see the hearing ability of treated children dramatically progress and the new study shows added benefits of the gene therapy when administrated to both ears, including the ability for sound source localization and improvements in speech recognition in noisy environments.”

The researchers noted their team’s goal was always to treat children in both ears to achieve the ability to hear sound in three dimensions, a capability important for communication and common daily tasks such as driving.

“Restoring hearing in both ears of children who are born deaf can maximize the benefits of hearing recovery,” said lead study author Yilai Shu MD, PhD, professor, director of Diagnosis and Treatment Center of Genetic Hearing Loss affiliated with the Eye & ENT Hospital of Fudan University in Shanghai, “These new results show this approach holds great promise and warrant larger international trials.”

Over 430 million people around the world are affected by disabling hearing loss, of which congenital deafness constitutes about 26 million of them. Up to 60 percent of childhood deafness is caused by genetic factors. Children with DFNB9 are born with mutations in the OTOF gene that prevent the production of functioning otoferlin protein, which is necessary for the auditory and neural mechanisms underlying hearing.

This new study is the first clinical trial to use bilateral ear gene therapy for treating DFNB9. The new research presents an interim analysis of a single-arm trial of five children with DFNB9 who were observed over either a 13-week or 26-week period at the Eye & ENT Hospital of Fudan University in Shanghai, China. Shu injected functioning copies of the human OTOF transgene carried by adeno-associated virus (AAV) into the inner ears of patients through a specialized, minimally invasive surgery. The first case of bilateral treatment was conducted in July 2023. During follow-up, 36 adverse events were observed, but no dose-limiting toxicity or serious events occurred. All five children showed hearing recovery in both ears, with dramatic improvements in speech perception and sound localization. Two of the children gained an ability to appreciate music, a more complex auditory signal, and were observed dancing to music in videos captured for the study. The trial remains ongoing with participants continuing to be monitored.

In 2022, this research team delivered the first gene therapy in the world for DFNB9 as part of a trial of six patients in China treated in one ear. That trial, which had results published in The Lancet in January 2024, showed five of six children gained improvements in hearing and speech. Shu initially presented the data at the 30th annual congress of European Society of Gene and Cell Therapy (ESGCT) in Brussels, Belgium in October 2023, becoming the first in the world to report clinical data on using gene therapy to restore hearing.

“These results confirm the efficacy of the treatment that we previously reported on and represent a major step in gene therapy for genetic hearing loss,” said Shu. Shu trained under Chen for four years as a postdoctoral fellow at Mass Eye and Ear, with their collaboration continuing for more than a decade since he returned to Shanghai.

“Our study strongly supports treating children with DFNB9 in both ears, and our hope is this trial can expand and this approach can also be looked at for deafness caused by other genes or non-genetic causes,” added Chen, who is also an associate professor of Otolaryngology–Head and Neck Surgery at Harvard Medical School. “Our ultimate goal is to help people regain hearing no matter how their hearing loss was caused.”

Currently, there are no drugs available to treat hereditary deafness, which has made room for novel interventions like gene therapies.

Mass General Brigham’s Gene and Cell Therapy Institute is helping to translate scientific discoveries made by researchers into first-in-human clinical trials. Chen and his colleagues are working with the Institute to develop platforms and vectors with good manufacturing practice standards that would enable his team to more easily test this therapeutic approach with other genes in the future.

The authors note that more work is needed to further study and refine the therapy. The bilateral study requires more consideration compared to the unilateral (one-ear) study as operations in both ears, in the course of one surgery, doubles the surgical time. Furthermore, by injecting double doses of AAVs into the body, the immune response is likely to be stronger and the potential for adverse effects could be greater. Looking ahead, more patients as well as a longer follow-up duration are necessary, and continued analysis of gene therapies and cochlear implants in larger randomized trials will be valuable.

Reference:

Wang, H., Chen, Y., Lv, J. et al. Bilateral gene therapy in children with autosomal recessive deafness 9: single-arm trial results. Nat Med 30, 1898–1904 (2024). https://doi.org/10.1038/s41591-024-03023-5

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Blood Urea Nitrogen-to-Albumin Ratio Predicts 28-Day Mortality in ICU Patients with CKD: Study

Researchers have found in a new study that Blood Urea Nitrogen-to-Albumin Ratio (BAR) shows a significant association with 28-day mortality risk in ICU patients suffering from chronic kidney disease (CKD), highlighting its potential as a valuable tool for mortality risk stratification.

Chronic kidney disease (CKD) is prevalent worldwide, with patients facing significant mortality risk in intensive care units (ICUs). Early identification of high-risk CKD patients is crucial for improving clinical outcomes. The blood urea nitrogen to albumin ratio (BAR) is a simple and measurable indicator, but its relationship with 28-day mortality in CKD patients is not well established. This study aimed to investigate this association. They conducted a retrospective analysis of eligible CKD patients from the MIMIC IV database. The association between the BAR and 28-day mortality was assessed using Kaplan-Meier survival curves, multivariable Cox regression models, and restricted cubic spline models. Results: A total of 4,625 patients were included, with a 28-day mortality rate of 25.2%. Kaplan-Meier survival curve analysis indicated that patients in the high BAR tertile had significantly lower survival probabilities than those in the low BAR tertile. The adjusted Cox regression model showed that compared to low BAR patients (T1 ≤ 9.8 mg/g), those in T2 (10.0-17.4 mg/g) and T3 (≥ 17.5 mg/g) had increased risks of 28-day mortality, with HRs of 1.49 (95% CI: 1.26–1.76) and 2.04 (95% CI: 1.73–2.40), respectively. Restricted cubic spline analysis indicated a nonlinear association. The BAR is significantly associated with 28-day mortality risk in ICU patients with CKD and may serve as a valuable tool for mortality risk stratification.

Reference:

He, K., Zhu, Y., Wang, W. et al. Association between the blood urea nitrogen to serum albumin ratio and the risk of mortality in patients with chronic kidney disease: a cohort study. BMC Nephrol 26, 275 (2025). https://doi.org/10.1186/s12882-025-04214-z

Keywords:

Blood, Urea, Nitrogen-to-Albumin, Ratio, Predicts, 28-Day, Mortality, ICU Patients, CKD, Study, He, K., Zhu, Y., Wang, W.

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Reflux recurrence risk after laparoscopic fundoplication similar in Both Erosive and Nonerosive GERD: JAMA

A new study published in the Journal of American Medical Association showed that reflux recurrence risk after laparoscopic fundoplication was similar in patients with nonerosive and erosive gastroesophageal reflux disease (GERD), challenging the notion that nonerosive GERD is less suitable for surgery. The findings suggest that absence of erosive disease on endoscopy should not preclude antireflux surgery.

With a more benign history of the disease and less sensitivity to antireflux drugs, nonerosive GERD is increasingly being seen as a distinct entity from erosive GERD. It is unknown if antireflux surgery works better for erosive GERD than nonerosive GERD. And so, to determine if individuals with nonerosive GERD experience greater reflux symptoms following antireflux surgery than those with erosive GERD, this study was carried out.

All patients in Finland and Sweden who had primary laparoscopic fundoplication for GERD between January 1, 1996, and December 31, 2019 were included in this population-based cohort analysis. Between March and April of 2024, statistical analysis was carried out. The primary exposure was comparing individuals with erosive GERD (i.e., erosive esophagitis found during preoperative endoscopy) with those with nonerosive GERD (i.e., no erosive esophagitis or Barrett esophagus found during preoperative endoscopy).

Reflux recurrence was the primary outcome, which was defined as secondary antireflux surgery or postoperative antireflux medication for at least 6 months. After controlling for age, sex, comorbidity, hospital volume of antireflux surgery, calendar year, and country, Poisson regression yielded hazard ratios (HRs) with 95% confidence intervals.

Of the 6,194 patients who had primary fundoplication, 2700 (43.6%) were diagnosed with nonerosive GERD and 3494 (56.4%) with erosive GERD (median age, 53 years [IQR, 42-62 years]; 3310 women [53.4%]).

In patients with nonerosive GERD (17.1% [461 of 2700]) and those with erosive GERD (17.1% [596 of 3494]), the frequency of reflux recurrence was comparable across a follow-up period of up to 23 years (range, 0-23 years; median, 8.8 person-years [IQR, 4.3-13.5 person-years]).

When examining recurrence by antireflux medication (HR, 1.04; 95% CI, 0.90-1.21) and secondary antireflux surgery (HR, 0.91; 95% CI, 0.75-1.10) separately, patients with nonerosive GERD had a similar overall risk of reflux recurrence as patients with erosive GERD (adjusted HR, 0.98; 95% CI, 0.87-1.11).

The HRs of the different follow-up groups following fundoplication and analyses stratified by the six factors in the multivariable model did not differ from one another. Overall, evidence suggesting nonerosive GERD is less responsive to antireflux drugs contradicts this conclusion. Therefore, the lack of erosive GERD seen during an upper endoscopy cannot be used as justification for skipping antireflux surgery.

Source:

Holmberg, D., Bielik, J., Santoni, G., Ness-Jensen, E., von Euler-Chelpin, M., Kauppila, J. H., & Lagergren, J. (2025). Reflux recurrence after laparoscopic fundoplication for nonerosive gastroesophageal reflux disease. JAMA Network Open, 8(6), e2517754. https://doi.org/10.1001/jamanetworkopen.2025.17754

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Instant Coffee and Genetics May Raise Risk of Dry Age-Related Macular Degeneration: Study

Approximately 200 million people globally live with age-related macular degeneration (AMD), with the majority affected by its dry form. While known risk factors include both genetics and lifestyle, a new study suggests that the combination of genetic predisposition and consumption of instant coffee may further increase the risk of developing dry age-related macular degeneration.

Coffee is a popular beverage, and previous cohort studies suggest it may reduce the risk of age-related macular degeneration (AMD). However, confounding factors in these studies necessitate further exploration of causal relationships using advanced methods. We obtained data on coffee consumption from genome-wide association studies (GWAS) and the latest age-related macular degeneration-related GWAS summary data from the Finngen consortium R11. We assessed their genetic correlation using linkage disequilibrium score regression (LDSC), explored causal associations using Mendelian randomization (MR), and identified shared genetic loci via colocalization. The results revealed a genetic correlation between instant coffee consumption and dry age-related macular degeneration, with each standard deviation (SD) increase in instant coffee intake associated with a corresponding odds ratio (OR) of approximately 6.92 for dry age-related macular degeneration, indicating a 6.92-fold increased risk. However, colocalization analysis did not show shared genetic variants between instant coffee consumption and age-related macular degeneration. Instant coffee may increase the risk of age-related macular degeneration, and reducing its intake could help prevent dry age-related macular degeneration. People at high-risk for age-related macular degeneration should avoid instant coffee. This study aids clinicians in identifying dietary factors, particularly instant coffee consumption, as potential risks for age-related macular degeneration. By providing genetically based causal evidence, our findings support the development of personalized age-related macular degeneration prevention strategies. Clinicians can advise patients to reduce instant coffee intake based on genetic risk profiles, offering a precision approach to reduce dry age-related macular degeneration risk. These interventions may significantly contribute to age-related macular degeneration prevention and treatment.

Reference:

Jia, Q., Z. Zha, S. Li, Y. Zhang, L. Ke, and S. Liu. 2025. “ Genetic Correlation and Mendelian Randomization Analyses Support Causal Relationships Between Instant Coffee and Age-Related Macular Degeneration.” Food Science & Nutrition 13, no. 6: e70439. https://doi.org/10.1002/fsn3..

Keywords:

Instant Coffee, Genetics, May, Raise, Risk, Dry, Age-Related, Macular, Degeneration, Study, Jia, Q., Z. Zha, S. Li, Y. Zhang, L. Ke, and S. Liu.

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Icariin Shows Kidney-Protective Effects Against Contrast-Induced Injury: Study

Researchers have discovered in a new research that oral administration of icariin at a dose of 100 mg/kg demonstrated significant renoprotective effects by mitigating contrast-induced renal injury. The protective mechanisms included anti-inflammatory, anti-apoptotic, and antioxidant actions.

Currently, the use of contrast agents in interventional procedures and imaging has been increasing. Icariin, an active component of Epimedium, offers beneficial biological activities such as antioxidation and anti-inflammation. Therefore, our study aimed to investigate the protective role of icariin and its underlying mechanisms against contrast-induced nephropathy (CIN). They divided twenty-four rats into four groups (n = 6 each): control group icariin-only treated group, contrast-induced nephropathy (CIN) group, and CIN+Icariin group, with six rats in each group. We performed renal function tests (serum creatinine and blood urea nitrogen (BUN) and histological evaluations. Additionally, we measured malondialdehyde (MDA) and superoxide dismutase (SOD) levels in renal supernatant and used ELISA to quantify caspase-8, caspase-9, cytochrome c, Bcl-2 associated protein x (Bax), and B cell lymphoma/leukemia 2 protein (Bcl-2) levels. We assessed nuclear factor kappa beta (NF-κB) and interleukin-1 beta (IL-1β) gene expression and evaluated immunoexpression of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), CD68, and caspase-3. Results: Icariin showed nephroprotective effects against CIN, demonstrated by reduced creatinine and BUN; decreased MDA, IL-6, NF-κB, TNF-α, IL-1β, CD68, caspase-8, caspase-9, Bax, and cytochrome c; and increased SOD and Bcl-2 levels. Renal histology improved in the CIN+Icariin group compared to CIN group. Oral administration of 100 mg/kg icariin exhibited renoprotective effects against contrast-induced renal injury through anti-inflammatory, anti-apoptotic, and antioxidant mechanisms.

Reference:

Hanan A. Elgendy, Amira Osman, Amira E. Farage, Medhat Taha, Sara Abubakr, Alaa.M. Badawy, Mohie Mahmoud Ibrahim, Ahmed Nabawy Ahmed Nasr, Hala Mahfouz, Tourki A.S. Baokbah, Ahmed shaban Abdelmonsef, Mohamed Ezzat Mahmoud, Ahmed Abdel-monem Elmetwally, Abdulrahman I. AbuAqil, Nora Elshehawy Helal, Icariin mitigates experimental contrast-induced nephropathy: Mechanistic insights, Tissue and Cell, Volume 96, 2025,

103020, ISSN 0040-8166, https://doi.org/10.1016/j.tice.2025.103020.

(https://www.sciencedirect.com/science/article/pii/S0040816625003003)

Keywords:

Icariin, Shows, Kidney-Protective, Effects, Against, Contrast-Induced, Injury, Study, Hanan A. Elgendy, Amira Osman, Amira E. Farage, Medhat Taha, Sara Abubakr, Alaa.M. Badawy, Mohie Mahmoud Ibrahim, Ahmed Nabawy Ahmed Nasr, Hala Mahfouz, Tourki A.S. Baokbah, Ahmed shaban Abdelmonsef, Mohamed Ezzat Mahmoud, Ahmed Abdel-monem Elmetwally, Abdulrahman I. AbuAqil, Nora Elshehawy Helal

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COPD Patients Face Earlier Mortality and Higher Comorbidity Burden: Study

Researchers have found in a real-world observational retrospective cohort study that patients with COPD died at a younger age and experienced more comorbidities compared to matched controls without COPD.

Patients with COPD suffer from various comorbidities, seemingly leading to a collective increase in morbidity and mortality. However, comorbidities with COPD have been largely unreported. Using healthcare claims data, only the deceased among around 250,000 COPD patients diagnosed in 2011– 2018 were evaluated by cause of death (cumulative incidence without competing risk) across a period of up to eight years. Results were compared with 1:1 propensity score-matched controls. Additionally, the prevalence of comorbidities in deceased patients was compared. Results: On average, deceased COPD patients and matched controls lived to be 75.7 and 78.0 years, respectively, and COPD patients had more comorbidities prior to death (mean 4.53 and 3.65). Both respiratory and cardiovascular-related deaths were more likely in COPD patients than in their matched controls (3.3 and 1.6 percentage points higher after eight years), and this was more extreme (9.8 and 3.4 percentage points higher, respectively) in the COPD subgroup with multiple/severe exacerbations; cumulative incidence of death increased with increasing COPD severity. Comorbidity prevalence, especially cardiovascular-related, was higher in COPD patients than in matched controls; COPD patients had a 42% higher risk of heart failure (RR 1.42; 1.38– 1.47), 30% higher risk of ischemic heart disease (RR 1.30; 1.25– 1.35), and 27% increased risk of atrial fibrillation (RR 1.27; 1.21– 1.32).

Conclusion: In this real-world observational retrospective cohort study, we found patients with COPD died at a younger age, and developed more comorbidities, than matched controls.

Reference:

Vogelmeier CF, Friedrich FW, Timpel P, Kossack N, Diesing J, Pignot M, Abram M, Gediga M, Halbach M. Comorbidities and Cause of Death in COPD Patients Compared to Non-COPD Controls: An 8-year Observational Retrospective Healthcare Claims Database Cohort Study. Int J Chron Obstruct Pulmon Dis. 2025;20:2117-2130

https://doi.org/10.2147/COPD.S488701

Keywords:

COPD, Patients, Face, Earlier, Mortality, Higher, Comorbidity, Burden, Study, exacerbations, mortality, cardiovascular disease, respiratory death, cardiovascular death, multimorbidity, Vogelmeier CF, Friedrich FW, Timpel P, Kossack N, Diesing J, Pignot M, Abram M, Gediga M, Halbach M. Comorbidities

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Roflumilast Foam as a Promising Topical Treatment for Scalp and Body Psoriasis: Phase 3 ARRECTOR Trial

Canada: In a major development for topical psoriasis therapy, researchers have found that roflumilast foam, 0.3%, applied once daily, significantly improves symptoms in patients with scalp and body psoriasis. The findings from the ARRECTOR Phase 3 randomized clinical trial, published in JAMA Dermatology, highlight both the efficacy and safety of the formulation in adolescents and adults.

The ARRECTOR trial, a double-blind, vehicle-controlled study, enrolled 432 participants aged 12 years and older. The participants presented with plaque psoriasis affecting up to 25% of the body, including a minimum of 10% scalp involvement. Conducted across 49 sites in the United States and Canada, the trial ran from August 2021 to June 2022.

Participants were randomly assigned to receive either roflumilast foam or a placebo (vehicle) once daily for eight weeks. The trial’s co-primary endpoints were based on the Scalp Investigator Global Assessment (S-IGA) and Body IGA (B-IGA), which measured the percentage of patients who achieved either a “clear” or “almost clear” status along with a minimum two-grade improvement from baseline.

Key findings were as follows:

  • By week 8, 66.4% of patients treated with roflumilast foam achieved Scalp Investigator Global Assessment (S-IGA) success, compared to 27.8% in the vehicle group.
  • Body Investigator Global Assessment (B-IGA) success was achieved by 45.5% of the roflumilast group versus 20.1% in the placebo group.
  • These results were statistically significant, indicating the strong efficacy of roflumilast foam.
  • Itch relief was measured using the Scalp Itch Numeric Rating Scale (SI-NRS) and Worst Itch NRS (WI-NRS).
  • There were significant improvements in itch as early as 24 hours after the first application of roflumilast foam.
  • The improvements in itch persisted through weeks 2, 4, and 8, with the roflumilast group consistently showing better outcomes than the control group.
  • Both groups experienced low rates of adverse events, and roflumilast was well tolerated.
  • There were no new safety concerns, highlighting the favorable safety profile of roflumilast foam.
  • The findings are significant, especially since existing topical treatments for scalp psoriasis often have limitations concerning tolerability, formulation, and long-term use.

The researchers note that roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which targets inflammatory pathways central to psoriasis pathogenesis. Its foam formulation allows for easier application on hairy areas like the scalp, addressing one of the common barriers to patient adherence in topical treatment regimens.

“Overall, the findings support roflumilast foam, 0.3%, as a viable and convenient monotherapy for managing mild to moderate psoriasis involving both the scalp and body. With its promising efficacy, rapid symptom relief, and favorable safety profile, this treatment could represent a significant step forward in dermatologic care,” they concluded.

Reference:

Gooderham MJ, Alonso-Llamazares J, Bagel J, et al. Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. JAMA Dermatol. Published online May 07, 2025. doi:10.1001/jamadermatol.2025.1136

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High-Alcohol Medicinal Preparations to Come Under Schedule H1: Govt Panel Approves Rule Change

New Delhi: The Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945 to regulate the alcohol content in tinctures and other alcoholic preparations in view of concerns regarding their illegal sale through pharmacies.

During its 66th meeting held on June 17, 2025, the agenda was taken up for discussion as part of ongoing efforts to curb the misuse of high-alcohol-content medicinal products that are being diverted for non-medical purposes.

As per the official meeting minutes, “DCC was apprised that the proposal was deliberated in 92nd DTAB meeting wherein the DTAB agreed that the rules may be amended and exemption provided for alcoholic preparations containing the alcohol content 30ml or above in Schedule K may be removed and such preparations may be included in Schedule H1.”

This recommendation from the Drugs Technical Advisory Board (DTAB) was aimed at bringing tighter regulatory control over such preparations by removing the exemption under Schedule K and instead placing them under Schedule H1. To mention, Schedule H1 is a category under the Drugs and Cosmetics Rules, 1945 that includes prescription drugs which require strict monitoring, including mandatory maintenance of sale records and prescription retention by pharmacies. It is intended to prevent misuse of certain antibiotics, psychiatric drugs, and other high-risk medicines.

Also Read: Govt To Amen Schedule K of Drugs Rules 1945 To Exempt Antiseptics From Sale License

The committee was further informed that “a draft notification was prepared in the matter. However, it was decided to discuss the matter in the DCC afresh.”

Following a detailed review of the draft notification, the DCC endorsed the proposal. As per the minutes, “DCC discussed the draft notification prepared for the purpose and after detailed deliberation agreed with the proposal to appropriately amend the Drugs Rules, 1945.”

The proposed amendment is expected to enhance control over the availability and dispensing of high-alcohol medicinal preparations, addressing rising concerns over their potential misuse, especially in vulnerable populations.

The move also aligns with the broader objective of strengthening the drug regulatory framework to ensure that pharmaceutical products are used strictly for therapeutic purposes.

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