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The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization in Great Britain for delgocitinib cream (Anzupgo, Leo Pharma) for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate.
The IGNITE study was a 24-week, randomized, placebo-controlled, double-blind study to assess the efficacy, safety and tolerability of rocatinlimab monotherapy every four weeks in 769 adults with moderate to severe AD, including patients previously treated with a biologic or systemic Janus kinase (JAK) inhibitor medication. At week 24, 42.3%
Skin Conditions Conditions like eczema, psoriasis, or seborrheic dermatitis can irritate the skin around the brows, leading to hair loss. Dermatology Clinics. Microblading: Safety and Efficacy in Eyebrow Enhancement. Clinical and Aesthetic Dermatology. Journal of Cosmetic Dermatology. Shapiro, J., & Maddin, S.
This approval is based on positive results from the phase III ARCADIA clinical trial program which evaluated the efficacy and safety of nemolizumab in combination with background TCS, with or without TCI, versus placebo in combination with TCS, with or without TCI, in 1,728 patients aged 12 or older with moderate to severe atopic dermatitis.
It has great efficacy and safety and is oral… [This means] no shot and no risk of anaphylaxis.” Upadacitinib’s (Rinvoq, AbbVie) 5-yr safety data show that it is REALLY SAFE and effective in AD, and abrocitinib (Cibinqo, Pfizer) is safe as well.” Hands Up for New CHE therapies Chronic hand eczema (CHE) will also get some love in 2024.
Rezpegaldesleukin is a first-in-class interleukin-2 receptor (IL-2R) agonist that proliferates and activates regulatory T cells (Tregs) with promising dose-dependent clinical activity in multiple skin disease settings. Robin, President and CEO of Nektar Therapeutics, in a news release.
“We are thankful to the patients and medical experts whose insights informed our clinical trials, which assessed nemolizumab’s ability to reduce the symptoms of itch and skin lesions. In the ARCADIA program, nemolizumab clinically improved skin lesions and rapidly improved itch and sleep disturbance.
Infants of mothers randomized to cut out eggs, milk, and fish were significantly less likely to have eczema even years later. Eczema, also known as atopic dermatitis, is a chronic inflammatory skin disease. Previously, I talked about the safety and efficacy of other, more natural treatments. But what about diet?
This grant will fund a collaborative effort to investigate the safety, tolerability, efficacy, and durability of response of subcutaneous administration of dupilumab in pediatric patients with extensive alopecia areata, defined as affecting at least 30% of the scalp.
Delgocitinib cream continues to perform well in chronic hand eczema (CHE) with limited systemic exposure, according to two studies presented at the 2024 Winter Clinical Dermatology Conference in Honolulu, Hawaii. The post New Research Supports the Safety and Efficacy of Delgocitinib in CHE appeared first on The Dermatology Digest.
Social media significantly influences the popularity of retinol among young people, leading to increased experimentation without considering safety. However, there are concerns about the safety of using retinol on younger skin due to the physiological differences between children’s and adults’ skin.
The approval is based on previously available human safety data and data from a well-controlled animal study in which ACAM2000 vaccine was shown to be effective in protecting against mpox virus exposure. The clade I variant of mpox is characterized by more severe clinical outcomes and a higher case fatality rate.
In comparison, facial razors are tools that feature a safety guard and sit on the skin at a 35-degree angle and were designed to be used at home. Dermaplaning Regret #2: Your Breakouts Worsen According to the Cleveland Clinic , the sliding motion of dermaplaning can make breakouts worse by spreading bacteria around.
Aldeyra Therapeutics’ investigational RASP modulator ADX-629 performed well in a Phase 2 clinical trial of patients with atopic dermatitis (AD), according to topline results. The open-label, single-center Phase 2 clinical trial of ADX-629 included eight mild-to-moderate AD patients.
The drug demonstrated significant and clinically relevant improvements in itch, patient-assessed quality-of-life indicators, inflammation, and safety, with minimal side effects and strong patient tolerability when compared to baseline.
The research was presented by Jonathan I Silverberg, MD, Associate Professor of Dermatology and Director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine in Washington, DC, during the late breaker session at Maui Derm 2024. Safety was assessed throughout the study.
55% of people experienced clinically meaningful itch relief ( Peak Pruritus Numerical Rating Scale ≥4-point improvement) §. 55% of people experienced clinically meaningful itch relief ( Peak Pruritus Numerical Rating Scale ≥4-point improvement) §. No new safety signals were observed and there were no serious adverse events reported.
The overwhelming majority of people with atopic dermatitis (AD) treated with investigational roflumilast cream 0.15% (Zoryve, Arcutis) showed a measurable improvement in Eczema Area and Severity Index (EASI) in 4 weeks, according to new pooled analyses from two Phase 3 studies. Fully 91.5% Importantly, EASI-90 was observed in 22.4%
Tim Raducha-Grace Named Chief Platform Officer at Zerigo Health Tim Raducha-Grace is the new Chief Platform Officer at Zerigo Health, a connected phototherapy platform that couples a handheld Narrow-band ultraviolet B (NB-UVB) light device with a smartphone app and team of care providers to allow patients to treat psoriasis and eczema at home.
and Sanofi), adding efficacy and safety data for people aged 12 years and older with atopic dermatitis (AD) and uncontrolled moderate-to-severe hand and/or foot involvement. or less,” says Dr. Guttman-Yassky, the Director of the Occupational Dermatitis Clinic and Director of the Laboratory for Inflammatory Skin Diseases.
Higher levels of stress are correlated to inflammation, which can manifest in acne, eczema, and psoriasis flare-ups. Diverse Skincare Matters There have been rumors that the FDA is changing its guidelines to require clinical trials on the darkest skin tones on the Fitzpatrick scale.
In addition, results from the phase III ARCADIA clinical trials in atopic dermatitis (AD) found that nemolizumab-treated patients who responded at 16 weeks maintained skin and itch responses through to week 48, even when dosing was reduced from every four to every eight weeks. No new safety signals were observed in this trial.
Skin Conditions (Eczema, Psoriasis, Contact Dermatitis) as Causes of Dry, Itchy Scalp Various skin conditions can lead to a dry, itchy scalp: a. Eczema (Dermatitis): Symptoms : Red, itchy, scaly patches on the scalp. 7] Triggers and Aggravators Common for Eczema and Psoriasis : Stress, hormonal changes, and environmental factors.
achieved an Eczema Area and Severity Index (EASI) of 75, 90, and 100, respectively. Efficacy measures for patients in the group who remained on upadacitinib indicated that a proportion of patients achieved clinically meaningful improvements in both skin and itch outcomes after continuing treatment. In the switchers, 47.6%
The new findings support the quarterly dosing of amlitelimab 250mg with a 500mg loading dose (LD) now being investigated in a larger Phase 3 clinical program (OCEANA). Moreover, high responder rates were also observed in participants who were taken off amlitelimab. This could offer an important benefit in the treatment of AD patients.”
Based on these data, AbbVie will advance its clinical program of lutikizumab in HS to Phase 3. Kimball, MD, MPH, a professor of Dermatology at Harvard Medical School and the President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center in Boston, in a news release. in the placebo group.
The DNA Connection Deep in our DNA, there’s a primordial theme of slowing down, connection, and safety, said Dr. Barr. You can be activated…like falling behind in the clinic or navigating a challenging patient interaction and you can ride the wave of your stress response and stay within what we call ‘the window of capacity.’”
The new AD guidelines also: • Highlight the safety of the topical calcineurin inhibitors with typical usage once or twice daily. Clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation were paramount. Suggest against elimination diets for AD.
A recently published study from the Cleveland Clinic shows that integrative therapies that include massage therapy, can improve the physical, mental and social health for patients with chronic, non-cancer related pain without increased use of opioid medications.
"The eyelids are very vascular, and the eyelid skin is very thin; this will make them more apparent under the eyelid skin and cause the appearance of dark circles," Miss Elizabeth Hawkes, consultant ophthalmic and oculoplastic surgeon at London's Cadogan Clinic, told POPSUGAR.
has given its official nod to delgocitinib (Anzupgo, Leo Pharma) cream for adults with moderate to severe chronic hand eczema (CHE). These trials evaluated the safety and efficacy of delgocitinib compared to cream vehicle. The European Commission (E.C.) In addition, the U.S. Both trials met their primary and all secondary endpoints.
“The approval of Adbry for pediatric patients living with moderate-to-severe atopic dermatitis expands the therapeutic options for those living with this disease who historically have had a limited selection to choose from,” says Julie Block, President and CEO of the National Eczema Association, in a news release.
“The approval of Adbry for pediatric patients living with moderate-to-severe atopic dermatitis expands the therapeutic options for those living with this disease who historically have had a limited selection to choose from,” says Julie Block, President and CEO of the National Eczema Association, in a news release.
The Phase 2a trial ( NCT05984784 ) evaluates the safety, pharmacokinetics, and efficacy of IMG-007 in adult patients with moderate-to-severe AD who had inadequate response to and/or intolerant of topical therapies. Key study endpoints include safety and percent change from baseline in eczema area and severity index (EASI) over time.
“The approval of Adbry for pediatric patients living with moderate-to-severe atopic dermatitis expands the therapeutic options for those living with this disease who historically have had a limited selection to choose from,” says Julie Block, President and CEO of the National Eczema Association, in a news release.
The trials evaluated the efficacy and safety of nemolizumab in combination with background topical corticosteroids (TCS), with or without topical calcineurin inhibitors (TCI), versus placebo in combination with TCS, with or without TCI, in adolescent and adult patients with moderate-to-severe AD.
Her area of clinical expertise is in complex medical dermatology, skin cancer, and acne. He’s held key R&D, regulatory, quality, product safety, clinical & scientific affairs positions at Ciba, Dial, Henkel, ITG Brands, Newell Rubbermaid.
of children treated with roflumilast cream achieved a 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 4 compared to 20.6% Safety and tolerability results were consistent with previous trials of roflumilast cream 0.15% in patients aged 6 years with AD. Fully 35.3% for vehicle-treated subjects. of patients.
In addition, the Swiss approval is supported by the results from the head-to-head DELTA FORCE Phase 3 clinical trial, which evaluated the efficacy and safety of delgocitinib cream compared with oral alitretinoin capsules. The cream is fast-tracked by the U.S.
Delgocitinib cream (Anzupgo, LEO Pharma) met its primary endpoint in the Phase 3 DELTA China Trial of Chinese patients with moderate-to-severe chronic hand eczema (CHE). The 16-week safety profile of delgocitinib cream was consistent with previous pivotal trials, and the pharmacokinetics (PK) data supported low systemic exposure.
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