Search

Patients with mild-to-moderate psoriasis may have substantial quality-of-life impairment.To evaluate apremilast 30 mg twice daily for mild-to-moderate psoriasis.Phase 3, double-blind, placebo-controlled study in adults with mild-to-moderate psoriasis inadequately controlled or intolerant to ≥ 1 topical psoriasis therapy (NCT03721172). The primary endpoint was the achievement of static Physician Global Assessment score of 0 (clear) or 1 (almost clear) and ≥ 2-point reduction at week 16.Five hundred ninety-five patients were randomized (apremilast: 297; placebo: 298). The primary endpoint was met, with a significantly greater static Physician Global Assessment response rate observed at week 16 in the apremilast group compared with the placebo group (21.6% vs 4.1%; P .0001). All secondary endpoints were met with the achievement of body surface area-75 (33.0% vs 7.4%), body surface area ≤ 3% (61.0% vs 22.9%), ≥ 4-point reduction in Whole Body Itch Numeric Rating Scale (43.2% vs 18.6%), Scalp Physician Global Assessment 0 or 1 and ≥ 2-point reduction (44.0% vs 16.6 %), and changes from baseline in body surface area, Psoriasis Area and Severity Index, and Dermatology Life Quality Index (all P .0001). The most commonly reported adverse events (≥ 5%) with apremilast were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, consistent with prior studies.The study lacked an active-comparator arm.Apremilast demonstrated efficacy in mild-to-moderate psoriasis and safety consistent with the established safety profile of apremilast.

Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to 1 of 3 dosages or vehicle, with daily treatment for 42 days. Coprimary end points were the percentage of participants exhibiting ≥1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score by logistic regression, and change in HDSM-Ax as a continuous measure by analysis of covariance. Pair-wise comparisons were 1-sided with α = 0.10.At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P .05). Least-square mean (SE) changes in HDSM-Ax were -2.02 (0.14), -2.09 (0.14), 2.10 (0.14), and -1.30 (0.14) (all P ≤ .0001). Most treatment-related adverse events were mild or moderate.Not powered to detect changes in gravimetric sweat production.Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.

Efficacious topical medications for rosacea are needed. FMX103 1.5% is a novel topical minocycline foam that may have therapeutic benefits in treating rosacea while minimizing systemic adverse effects due to its topical route of delivery.To determine the efficacy, safety, and tolerability of 12 weeks of treatment with FMX103 1.5% topical minocycline foam for papulopustular rosacea.Two 12-week, phase 3, randomized, multicenter, double-blind, vehicle-controlled, 2-arm studies were performed in patients with moderate to severe papulopustular rosacea.Participants who received FMX103 1.5%, versus control individuals treated with vehicle, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P = .0031; FX2016-12: -18.54 vs -14.88; P .0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P = .0273; FX2016-12: 49.1% vs 39.0%; P = .0077). No serious treatment-related treatment-emergent adverse events occurred.The generalizability of these data from a controlled clinical trial should be examined in a real-world setting.FMX103 1.5% was efficacious for moderate to severe papulopustular rosacea and maintained a favorable safety profile.

One fascinating element of medical dermatology is the diversity of available therapeutic agents, and dermatologists are well versed in applying the mechanism of action of a drug to modify a disease process. Oral antibiotics are the ideal example of pharmacologic agents that are effective against inflammatory processes and have obvious roles in infectious diseases.

Many classes and preparations of immunomodulators are available to the clinician, serving as stimulatory or inhibitory influences on a variety of disease states. To maximize their efficacy, it is important for the clinician to take a step back from the usual routine of treating symptoms and consider the immune processes that took place to create inflammation, tumors, or responses to infections. From there, after considering the short-term and long-term consequences of the treatment, one can match the immune profile of the disease to the treatment. Most importantly, immunomodulators provide the opportunity to do what is best for the patient at that time, as well as for control of the future of the disease, whether it is acute or chronic.