Publications by authors named "Berk D"

Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials. Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.

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Article Synopsis
  • The study aimed to evaluate the effectiveness of a new topical roflumilast cream vehicle compared to a popular ceramide-containing moisturizer in improving skin barrier function for patients with mild asteatotic eczema.
  • Over 17 days, 40 patients applied the roflumilast vehicle on one leg and the moisturizer on the other, measuring transepidermal water loss (TEWL) and skin hydration at various intervals.
  • Results showed both treatments effectively improved skin hydration, with no significant differences in performance after day 1, indicating that the new vehicle is comparable to the established moisturizer.
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Article Synopsis
  • Safe and effective long-term topical treatments for atopic dermatitis (AD) are limited, leading to low adherence rates among patients.
  • The study aimed to assess the efficacy and safety of once-daily roflumilast cream (0.15%) compared to a vehicle cream in patients aged 6 and older with mild to moderate AD across two phase 3 trials.
  • Results showed that a significantly higher percentage of patients using roflumilast achieved treatment success and a notable reduction in eczema severity compared to those using the vehicle cream.
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Prymnesins, produced by the haptophyte Prymnesium parvum, are considered responsible for fish kills when this species blooms. Although their toxic mechanism is not fully understood, membrane disruptive properties have been ascribed to A-type prymnesins. Currently it is suggested that pore-formation is the underlying cause of cell disruption.

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Objective: To evaluate the role of Extended Scope (ES) audiologists in managing adult Ear Nose and Throat (ENT)/Otology waitlists and analyse patient re-presentation rate to the ENT service within 12 months of being discharged from the clinic.

Design: A retrospective cohort study assessing the efficacy of ES audiologists, measuring the discharge rate from ENT waitlists, the rate of escalation to ENT care, and the rate and reasons for any re-presentations to care.

Study Sample: 394 adult patients.

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  • Topical psoriasis treatments often have limited efficacy and safety, prompting a study on roflumilast cream's long-term effects.
  • In a phase 2 trial with 332 adult psoriasis patients, those who applied roflumilast cream daily for 52 weeks showed a high completion rate and only minimal adverse events.
  • Results indicated that the cream was effective, with about 44.8% of patients achieving significant improvement at Week 52, supporting its use for chronic treatment, including sensitive areas like the face.
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Background: The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions.

Objective: Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD).

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Harmful algal blooms kill fish populations worldwide, as exemplified by the haptophyte microalga Prymnesium parvum. The suspected causative agents are prymnesins, categorized as A-, B-, and C-types based on backbone carbon atoms. Impacts of P.

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Purpose: Plush animal pacifiers (detachable weighted stuffed animals) have gained popularity. Although pacifiers have well-known benefits, they can also affect the development of the cranio-facial-respiratory complex. The purpose of this study was to study the forces gener- ated on the maxillary arch region during the use of plush animal pacifiers.

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Background: Scalp psoriasis affects most patients with psoriasis, but it can be difficult to treat.

Objectives: To evaluate the efficacy and safety of once-daily roflumilast foam 0.3% on scalp and body psoriasis.

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Article Synopsis
  • Current treatments for seborrheic dermatitis are not very effective or safe, prompting the need for new options.
  • A clinical trial tested the safety and effectiveness of roflumilast foam, 0.3%, on adults with seborrheic dermatitis across 24 locations in the US and Canada.
  • In the trial, 73.8% of patients using roflumilast foam achieved significant improvement in their condition after 8 weeks, compared to those using a placebo.
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Background: Patients with atopic dermatitis (AD) need safe and effective topical treatments.

Objective: To assess safety and efficacy of roflumilast cream in patients with mild to moderate AD.

Methods: In this phase 2, proof of concept trial, patients (N=136) aged ≥12 years with AD were randomized to once-daily roflumilast cream 0.

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Background: Most patients with chronic plaque psoriasis receive topical treatment; however, available options lack a balance of efficacy with long-term safety and tolerability. Roflumilast cream 0.3% is a highly potent phosphodiesterase 4 (PDE4) inhibitor approved by the US FDA for treatment of psoriasis.

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Background: Itch is the most bothersome symptom reported by patients with psoriasis. Safe and effective treatments for psoriasis that also address itch are needed.

Objectives: To report effects of roflumilast cream on itch-related outcomes from a Phase 2b trial.

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Importance: Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis.

Objective: To evaluate the efficacy of roflumilast cream, 0.

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Single-use face masks can release microfibres upon exposure to environmental conditions. This study investigates the number of microfibres released in the presence and absence of UV irradiation and mechanical friction and the removal of the released microfibres in a simulated conventional wastewater treatment process. UV exposure results in a four-fold increase in the number of microfibres released from new masks and used masks resulting in ~2400 microfibres/mask and ~1100 microfibres/mask, respectively.

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The Psoriasis Area and Severity Index (PASI) is the most widely used clinical measure in clinical trials to assess disease severity of plaque psoriasis. However, the PASI is not a precise measure of severity with less precision when the regional area of involvement is < 10% of the BSA of a specific anatomical region. Degradation of precision results from the area score defaulting to '1' when the area of involvement within an anatomical region falls between 0% and 10% of the BSA for a given anatomical region.

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CDAGS Syndrome is a rare congenital disorder characterized by Craniosynostosis, Delayed closure of the fontanelles, cranial defects, clavicular hypoplasia, Anal and Genitourinary malformations, and Skin manifestations. We performed whole exome and Sanger sequencing to identify the underlying molecular cause in five patients with CDAGS syndrome from four distinct families. Whole exome sequencing revealed biallelic rare variants that disrupt highly conserved nucleotides within the RNU12 gene.

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Background: Roflumilast cream (ARQ-151) is a highly potent, selective phosphodiesterase-4 inhibitor in development for once-daily topical treatment of chronic plaque psoriasis. Objectives: To assess the safety and efficacy of once-daily roflumilast cream 0.5% and 0.

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Background: Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors have been effective in the treatment of psoriasis. Roflumilast cream contains a PDE-4 inhibitor that is being investigated for the topical treatment of psoriasis.

Methods: In this phase 2b, double-blind trial, we randomly assigned adults with plaque psoriasis in a 1:1:1 ratio to use roflumilast 0.

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We sought to evaluate the safety, tolerability, and patterns of use for the once-daily oral, narrow-spectrum antibiotic sarecycline in patients with moderate-to-severe acne vulgaris during a 40-week Phase III, multicenter, open-label extension study. Patients aged nine years or older with moderate-to-severe acne who completed one of two prior Phase III, double-blind, placebo-controlled, 12-week trials in which they received sarecycline 1.5mg/kg/day or placebo were included.

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Background: Thyroid autoimmunity has been associated with bipolar disorder (BD). However, results from previous studies on the seroprevalence of anti-thyroid peroxidase antibodies (TPO-abs) in BD are inconsistent.

Objectives: The aim of the present study is to investigate whether the seroprevalence and titer levels of TPO-abs are related to BD.

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Background and Purpose- In infants with perinatal arterial ischemic stroke (PAIS), early prognosis of neurodevelopmental outcome is important to adequately inform parents and caretakers. Early continuous neuromonitoring after PAIS may improve early prognosis. Our aim was to study early cerebral electrical activity and oxygenation measured by amplitude-integrated electroencephalography (aEEG) and near-infrared spectroscopy in term neonates with PAIS and relate these to the development of cerebral palsy and cognitive deficit.

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