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Dermal and Transdermal Drug Delivery Systems
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
Kenneth A. Walters, Majella E. Lane
Between April 2006 and October 2010, a total of 3,155 adverse events in 1,516 patients were reported (Pae et al., 2012). This represented 5.2% of the total exposures and was independent of causality. The most frequently reported adverse events were application site reactions and insomnia. There were no confirmed reports of hypertensive crisis with food at any selegiline dose level. To date, transdermal selegiline is the only FDA-approved antidepressant for patients with significant problems ingesting, tolerating or absorbing oral medications. Furthermore, it remains the only MAOI (monoamine oxidase inhibitor) that can be initiated at a therapeutic dose without dietary restrictions and has a low incidence of side effects when compared to other MAOIs (Bied et al., 2015; Cristancho and Thase, 2016).
Laboratory and Clinical Follow-Up
Published in Ayse Serap Karadag, Berna Aksoy, Lawrence Charles Parish, Retinoids in Dermatology, 2019
Nadide Burcu Öztürk, Berna Aksoy
Topical alitretinoin gel is indicated for Kaposi sarcoma, and got FDA approval in 1999. Adverse events related to topical treatment with alitretinoin gel tend to be mild to moderate in severity and are limited to the site of application. The most frequent adverse event is skin irritation occurring at the application site (32%) followed by paresthesia, itch, pain, and peeling (65). Physicians should inform patients about these application site reactions.
Current and future topical treatments for psoriasis
Published in M. Alan Menter, Caitriona Ryan, Psoriasis, 2017
Shivani Nanda, Linda Stein Gold
Tofacitinib is a JAK 1/3 inhibitor that is being evaluated in an ointment formulation. In a phase IIa, randomized, double-blinded, vehicle-controlled study, 71 patients were randomized to receive tofacitinib 2% ointment, tofacitimib ointment with a penetration enhancer, or either vehicle. At week 4, improvement in plaque severity scores in the formulation with the penetration enhancer was statistically superior to vehicle. Adverse events were mild to moderate and consisted of mainly local application site reactions.80 Although larger studies assessing long-term outcomes need to be conducted, tofacitinib appears to be a promising emerging topical treatment modality for psoriasis.
Intralesional cidofovir for the treatment of recalcitrant periungual warts
Published in Journal of Dermatological Treatment, 2023
In this series of cases, ILC was successful in resolving most recalcitrant periungual warts after one to four treatment sessions. Limitations of this case series include a small number of patients and follow-up restricted to 6 months for most cases with complete resolution. Patients with partial resolution continued treatment beyond the study window. Even considering these limitations, our results suggest that ILC can be successful in patients with periungual warts that have proven recalcitrant to standard therapy. ILC should not be used in patients with severe sulfonamide or probenecid hypersensitivity [2]. No systemic side effects were observed in this case series nor reported in the literature for intralesional administration. Application site reactions can occur and should be explained to patients prior to use. Given the risks to the nail of traditional therapies, we submit that ILC should be considered as a first-line therapy for periungual warts. To adequately understand the effectiveness of ILC, randomized clinical trials are necessary.
A critical review of the capsaicin 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet in adults
Published in Expert Review of Neurotherapeutics, 2021
Rory M. C. Abrams, Elizabeth J. Pedowitz, David M. Simpson
In the PACE trial [25] the most common adverse events associated with the capsaicin 8% patch were application site pain, burning, or erythema which was typically mild or moderate in intensity. Consistent with the STEP trial, all patients were pretreated with EMLA also containing lidocaine 2.5% and prilocaine 2.5%. The proportion of patients reporting application site reactions decreased from between the first and second applications to between the sixth and final treatments (application site pain: 30 min, −6.9%; 60 min, −7.9%; burning pain: 30 min, −2.8%; 60 min, −2.2%). The mean ‘pain now’ NPRS scores after patch application were low with peak mean pain scores occurring within 15 min of first patch removal (30-min application, 3.5 [IQR 2.0–5.0]; 60-min application 3.3 [IQR 1.0–5.0]). The ‘pain now’ NPRS scores decreased following the second patch removal. More patients in the 60-min application group (29.9%) required additional analgesic medications compared with the 30-min group (22.4%).
Capsaicin 8% dermal patch in clinical practice: an expert opinion
Published in Expert Opinion on Pharmacotherapy, 2020
Cesare Bonezzi, Amedeo Costantini, Giorgio Cruccu, Diego M.M. Fornasari, Vittorio Guardamagna, Vincenzo Palmieri, Enrico Polati, Pierangelo Zini, Anthony H Dickenson
Capsaicin creams of low concentrations (0.025–0.075%) have shown moderate efficacy in the topical treatment of PNP [1]. Nevertheless, these creams require several applications per day, and the initial burning sensation is often poorly tolerated. Qutenza®, which is a high-concentration (8%) capsaicin dermal patch, has been developed with the aim of providing long-lasting pain relief resulting from a single application. The capsaicin 8% dermal patch is approved in the EU, either alone or in combination with other medicinal products (for pain), for the treatment of PNP in adults [6]. Overall, patients using the capsaicin dermal patch reported limited adverse events. The general incidence of serious adverse events that resulted from controlled trials was 6% compared to 4% with the control patch [7]. The most common adverse reactions were application site reactions, such as dryness, erythema, edema, pain, papules and pruritus. Nevertheless, those reactions were mild to moderate in severity, resolved spontaneously within 7 days and did not preclude the completion of the treatment (99% of the patients completed ≥90% of the treatment) [8].