Physicians and patients have come to expect that our prescription topicals not only be efficacious but also minimally irritating and cosmetically pleasing. Much research and development effort are being spent to identify new vehicles to achieve these goals. Consumers are also demanding nonprescription products that give them noticeable results. The cosmeceutical industry, which accounts for multibillion dollars a year in sells, is on the forefront of the research. We reviewed the literature to identify and discuss some of those delivery systems used in consumer health products.
IntroductionCutaneous adverse events (AEs) have been observed in clinical studies of daclizumab high-yield process (HYP) in relapsing-remitting multiple sclerosis (RRMS). Here, we report cutaneous AEs observed in the randomized, double-blind, active-comparator DECIDE study (ClinicalTrials.gov identifier, NCT01064401).MethodsDECIDE was a randomized, double-blind, active-controlled phase 3 study of daclizumab HYP 150 mg subcutaneous every 4 weeks versus interferon (IFN) beta-1a 30 mcg intramuscular (IM) once weekly in RRMS. Treatment-emergent AEs were classified and recorded by investigators. Investigators also assessed the severity of each AE, and whether it met the criteria for a serious AE. Cutaneous AEs were defined as AEs coded to the Medical Dictionary for Regulatory Activities System Organ Class of skin and subcutaneous tissue disorders. The incidence, severity, onset, resolution, and management of AEs were analyzed by treatment group.ResultsCutaneous AEs were reported in 37% of daclizumab HYP-treated patients and 19% of IFN beta-1a-treated patients. The most common investigator-reported cutaneous AEs with daclizumab HYP were rash (7%) and eczema (4%). Most patients with cutaneous AEs remained on treatment (daclizumab HYP, 81%; IM IFN beta-1a, 90%) and had events that were mild or moderate (94% and 98%) and subsequently resolved (78% and 82%). Most patients with cutaneous AEs did not require treatment with corticosteroids or were treated with topical corticosteroids (daclizumab HYP, 73%; IM IFN beta-1a, 81%). Serious cutaneous AEs were reported in 14 (2%) daclizumab HYP patients and one (<1%) IM IFN beta-1a patient.ConclusionThere was an increased risk of cutaneous AEs with daclizumab HYP. While physicians should be aware of the potential for serious cutaneous AEs, the typical cutaneous AEs were mild-to-moderate in severity, manageable, and resolved over time.FundingBiogen and AbbVie Biotherapeutics Inc.Trial registrationClinicalTrials.gov identifier, NCT01064401.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0353-2) contains supplementary material, which is available to authorized users.
Background Intraoral metal contact allergy may result in mucositis that mimics lichen planus and the pathogenesis of squamous cell carcinoma.Methods Clinical records of all patients examined in the departments of dermatology and otorhinolaryngology at a tertiary-care academic medical center between June 1994 and June 2000 who had a diagnosis of intraoral squamous cell carcinoma adjacent to a metal dental restoration and who were patch tested with our metal series were reviewed retrospectively.
Eleven patients met the inclusion criteria.Results Ten patients (91%) had positive patch tests to metals. In eight (73%), the oral cancer was adjacent to a dental restoration containing a metal to which the patient was allergic.Prevalence of gold, mercury, silver, and copper allergy among these patients was substantially higher than that reported in the available worldwide patch-test clinic population.Conclusion Contact allergy to metal dental restorations may be a risk factor for development of intraoral squamous cell carcinoma.
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