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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Fire breaks out near AIIMS Trauma Centre after transformer blast

New Delhi: A fire broke out near the Trauma Centre of the All India Institute of Medical Sciences (AIIMS) in New Delhi on Thursday afternoon following a blast in an electric transformer, a Delhi Fire Services (DFS) official said.  

He added that no one was injured in the incident. 

“We received a call regarding a blast and a fire in an electric transformer at the AIIMS Trauma Centre at 3:34 pm. We rushed eight fire tenders to the spot. The fire was doused by 3:55 pm. No one was injured,” DFS chief Atul Garg said in a statement, according to news agency PTI.

Also Read:4 dead after smoke engulfs Kozhikode Medical College hospital, probe ordered

A fire officer told PTI that when their teams reached the spot, the staff of the AIIMS fire unit was already trying to bring the blaze under control.

“We immediately deployed the eight fire tenders and it took 30 to 40 minutes to douse the flames completely,” the officer said.

In a statement, the All India Institute of Medical Sciences (AIIMS) said, “We would like to inform that there was no fire at JPNATC, AIIMS Delhi. A fire incident occurred at an NDMC transformer located within the JPNATC complex, which was brought under control.”

“We are pleased to report that there were no injuries, no material loss and no disruption to the institute’s operations. All functions at the centre are operating normally,” the statement read.  

Medical Dialogues had earlier reported that a fire broke out in the burns ward of the government-run Victoria Hospital in Bengaluru, prompting the evacuation of 26 inpatients by the hospital staff. According to the preliminary investigation by the police, the fire broke out at around 3 a.m. in the burns ward due to a short circuit in the switchboard. A bed, register book, and other equipment were gutted in the incident. 

Also Read:Massive fire at Lucknow Hospital, 200 patients evacuated

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Physician associates provide safe care for diagnosed patients when directly supervised by a doctor

Physician associates provide safe and effective care when they work under the direct supervision of doctors and care for patients who have already been diagnosed, or when they undertake procedures for which they have been highly trained, finds a rapid review published in The BMJ.

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Large oncosomes in the blood may enable cancer diagnosis and monitoring

Cedars-Sinai investigators have discovered that large oncosomes—fluid-filled sacs released into the bloodstream by aggressive cancer cells—contain a consistent set of molecules across cancer types. Their findings, published in Cell Reports Medicine, highlight large oncosomes in the blood as a possible method of diagnosing and monitoring malignancies.

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Measles outbreak in Kentucky confirmed

There has been nationwide total of 1,267 confirmed cases of measles this year, with Kentucky being the latest state to announce an outbreak, the U.S. Centers for Disease Control and Prevention reported Wednesday.

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Carlyle to offload up to 10 percent stake in Piramal Pharma in Rs 26-27 billion deal: Report

U.S.-based private equity powerhouse Carlyle Group is reportedly gearing up to offload up to a 10 percent stake in Piramal Pharma, according to a Moneycontrol report citing sources.

The sale, expected to be executed through block trades, could earn Carlyle anywhere between Rs 26 billion to Rs 27 billion, the report added, as per Reuters.

Carlyle Group, through its affiliate Ca Alchemy Investments, had a 18% stake in Piramal Pharma as of March-end this year, exchange data showed. This planned sale would effectively slice that holding almost in half.

In October 2020, Medical Dialogues team reported that Piramal Pharma had completed the sale of 20 percent stake in the company for Rs 3,523.40 crore to Carlyle Group Inc. 

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Prevent 4th of July firework injuries by taking these simple steps

Fireworks are the pinnacle of many Fourth of July celebrations, and while they can be festive and fun, they can also land you in the emergency room if you don’t take proper precautions, experts warn.

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Considerable variation seen in commercial pricing for surgery services

Commercial pricing varies considerably for general surgery services, with facility prices exhibiting greater variability, according to a research letter published online June 25 in JAMA Network Open.

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7,000 beds in 5 Govt Hospitals by December 2025, says CM Revanth Reddy

Hyderabad: In a major step toward upgrading Telangana’s healthcare infrastructure, Chief Minister A Revanth Reddy announced the addition of nearly 7,000 beds across five upcoming government super-speciality hospitals, scheduled to be operational from December 9, 2025. 

The announcement was made during the inauguration of AIG Hospitals at Banjara Hills, where the Chief Minister also made a heartfelt appeal to doctors, both within India and abroad, to contribute to the state’s healthcare system as part of their social responsibility.

Also Read: Telangana CM lays foundation stone for 2000-bed Osmania General Hospital, Set to be completed in 2 years

According to TOI, doctors who studied in Hyderabad and Telangana but are now practising abroad, especially in the US and other countries, can give back to the state by offering their services for at least a week when they visit home,” the CM said. “The state govt will create a platform for voluntary registration of corporate doctors working in India and overseas to serve in govt hospitals,” he said.

Revanth Reddy emphasised that this effort not only offers a meaningful opportunity to give back but could also provide deeper professional satisfaction to doctors serving their communities.

He highlighted that doctors based in the US, UK, and other countries often return home to visit their families, and even a single in-person consultation during such visits can significantly impact patients. “That one consultation can help set a treatment course and lead to further digital follow-ups,” he said, reports the Hindu.

Mr. Reddy shared details of an ambitious plan to transform public health infrastructure in Telangana, announcing that five major government hospitals are currently under development and expected to be operational by December 2025. The upcoming facilities include the redevelopment of Osmania General Hospital in Goshamahal, new Telangana Institute of Medical Sciences (TIMS) campuses in Alwal, Sanathnagar, and LB Nagar, the expansion of Nizam’s Institute of Medical Sciences (NIMS), and the construction of a super-speciality hospital in Warangal.

He confirmed that the three TIMS facilities, the expanded NIMS, and the Warangal super-speciality hospital are all scheduled to be completed and operational by December 2025.

Underscoring the Congress-led government’s commitment to human development, the Chief Minister highlighted major allocations in this year’s budget, with a renewed focus on health and education. A total of ₹11,500 crore has been earmarked for the health sector, while ₹21,500 crore has been allocated to strengthen education.

The event also marked a significant milestone for AIG Hospitals, which inaugurated its new Banjara Hills facility. Dr. D. Nageshwar Reddy, Chairman of AIG Hospitals, shared that the expansion was a response to growing demand from residents of Secunderabad and central Hyderabad, who have long faced travel barriers to access specialized care.

Reflecting on the 25-year journey of AIG Hospitals, which began as a 300-bed gastroenterology-focused facility in Somajiguda, Dr. Reddy recounted a pivotal moment marked by a visit from former Chief Minister Y.S. Rajasekhara Reddy.

Also Read: Over Rs 600 crore Cost Escalation for Warangal Super Specialty Hospital: CM Orders probe

According to the Hindu, “Seeing the overcrowding at our Somajiguda facility, he told us, ‘We will give you land, go and build the best hospital in the world,’” Dr. Reddy recalled his conversation with the former Chief Minister.

Today, AIG stands as a nationally acclaimed institution with over 1,000 scientific papers, contributions to 50 medical textbooks, and more than 1,500 trained medical professionals. It continues to pioneer innovations in gastroenterology and other medical disciplines.

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