Learning curves: historical trends of FDA-reported adverse events for dermal fillers.

Dermal fillers are medical devices regulated by the US Food and Drug Administration (FDA); therefore, reported adverse events (AEs) are publicly available via OpenFDA. Evaluation of historical AE data trends may help distinguish between AEs related to expected learning curves associated with a new type of filler from AEs related to inherent characteristics of a product. In this study, the full history of AE data was evaluated to establish reproducible learning curves for FDA-approved dermal fillers. Reactions to AEs for new fillers that garner FDA approval or are awarded new indications should be in response to analysis of AE rate data and determination of whether they fit on a historically normal learning curve.

Topicals in skin rejuvenation: prescription topicals.

With the recent proliferation of over the counter cosmeceuticals, prescription topical skin treatments have the cache of being evidence-based and not being available outside the setting of a patient-physician interaction. In the setting of facial rejuvenation, patient demand for prescription topical skin treatments falls into three main roles: (1) stimulation of collagen production; (2) improvement of dyspigmentation; and (3) amelioration of adult acne.

Future directions in facial rejuvenation.

Future directions in the advancement and refinement of facial rejuvenation techniques represent a response to patient demand for higher aesthetic impact with less procedural downtime and with minimal scarring as evidence of previous surgery. With surgical procedures, the trend of innovation in response to demand has been toward more minimally invasive approaches that have the predictability and durability of results of more traditional approaches. With nonsurgical procedures, there have been new developments in achieving more significant aesthetic improvements with less downtime and less invasively.

Efficacy and safety study of tazarotene cream 0.1% for the treatment of brittle nail syndrome.

Brittle nail syndrome refers to nails that exhibit surface roughness, raggedness, and peeling. It is a common problem, with a higher prevalence among elderly patients. The goal of this study was to determine if tazarotene cream 0.1% ameliorates the signs and symptoms of brittle nails. In this open-label, single-center trial, participants applied tazarotene cream to the nails twice daily for 24 weeks. Signs and symptoms were rated by the investigators and by the participants during treatment and 12 weeks after discontinuation. Twenty participants were enrolled in the study; 1 participant withdrew prior to the 4-week followup visit. Of the 18 participants available for analysis (1 participant was excluded because baseline photographs were not available) for the primary end point of improvement in the physician global improvement assessment (PGIA), all 18 participants achieved improvement of the target nails at week 12 as well as 16 participants (88.9%) at week 24. All 18 participants had improvement in the PGIA score 12 weeks posttreatment at week 36. The physician global assessment (PGA) improved for 14 of 19 participants (73.7%) at both weeks 12 and 24; at week 24, 4 of 19 participants had achieved a PGA score of none. At week 36, 17 of 19 participants (89.5%) agreed that their nails had improved overall. Only 1 participant (5.3%) reported mild local irritation. This study demonstrated that tazarotene improves some of the changes noted in conjunction with brittle nail syndrome with minimal to no irritation.

Beyond wet-to-dry: a rational approach to treating chronic wounds.

OBJECTIVE: This article reviews the current recommendations for the classification and treatment of chronic wounds. With a rational approach and a thorough understanding of available treatment options, plastic surgeons can provide better-quality and more cost-effective wound care. METHODS: The authors reviewed the literature on the history of wound care and on recent advancements in wound care and also summarized the current clinical practices of the Johns Hopkins Wound Center. RESULTS: n/a. CONCLUSIONS: Optimized wound dressings decrease pain, diminish morbidity, and improve healing times.

Personal physicians as study investigators: impact on patients' willingness to participate in clinical trials.

BACKGROUND: We asked whether patients are more willing to participate (WTP) in a cardiovascular drug trial if their personal rather than an unfamiliar physician were engaged as the study investigator. METHODS: We approached 1440 randomly selected patients from 13 Maryland-based outpatient cardiology and general medicine clinics to complete an 86-item self-administered questionnaire. We then asked respondents their WTP if their personal rather than an unfamiliar physician were the study investigator, as well as their trust in physicians and quality of their health care experiences. RESULTS: Of 1132 patients eligible, 789 (70%) patients responded and 666 had complete data. Patients were "very likely/likely" to participate in the study 56% of the time if conducted by their personal compared to only 36% if by an unfamiliar physician (p<0.0001). After adjusting for age, race, gender, and socioeconomic and health status, only the presence of a family member or friend in health care was positively associated with "very likely/likely" WTP with unfamiliar physician (OR, 95% CI=1.42, 0.99-2.03). If by a personal physician, however, trust in physician (1.57, 1.16-2.11, per 1/5 unit increase), rating of health care quality (1.18, 1.06-1.31 per 1/10 unit increase), and having a family member or friend in health care (1.57, 1.16-2.11) were important predictors of WTP. CONCLUSION: Patients are much more likely to enroll in a clinical trial if their personal physician is engaged as a study investigator, which could relate to the importance of communication, trust, and familiarity with the health care system.

Diffuse fasciitis with eosinophilia developing after local irradiation for breast cancer.

This case describes a patient who developed diffuse fasciitis with eosinophilia (DFE) after an exaggerated local response to radiation following excision of a lymph node-negative breast cancer. Our patient's fasciitis was diffuse, involving both upper and lower extremities and the trunk at sites distant from the irradiation and tumor site. The fasciitis progressed after curative excision of the breast cancer rather than concurrently with active breast cancer and persisted despite therapy; there was no tumor reoccurrence. With three published cases linking localized eosinophilic fasciitis with breast cancer, and with the literature suggesting that DFE commonly presents after a traumatic trigger, the possibility that radiation therapy for breast cancer could be one such trigger is an important insight for clinicians treating the many patients who undergo breast cancer treatment each year.

Race, medical researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trials.

Minority underrepresentation exists in medical research including cardiovascular clinical trials, but the hypothesis that this relates to distrust in medical researchers is unproven. Therefore, we examined whether African American persons differ from white persons in perceptions of the risks/benefits of trial participation and distrust toward medical researchers, and whether these factors influence willingness to participate (WTP) in a clinical drug trial. Participants were self-administered a survey regarding WTP in a cardiovascular drug trial given to 1440 randomly selected patients from 13 Maryland outpatient cardiology and general medicine clinics. Patients reported their WTP, rated their perceived chances of experiencing health benefit and harm, and rated their distrust toward researchers. Of eligible participants, 70% responded, and 717 individuals were included: 36% African American and 64% white. African American participants possessed lower WTP than white participants (27% vs. 39%, p = 0.001) and had higher mean distrust scores than whites (p < 0.0001). African American participants more frequently reported that doctors would less fully explain research participation to them (24% vs. 13%, p < 0.001), use them as guinea pigs without their consent (72% vs. 49%, p < 0.001), prescribe medication as a way of experimenting on people without their knowledge (35% vs. 16%, p < 0.001), and ask them to participate in research even if it could harm them (24% vs. 15%, p = 0.002). African American participants also more often believed they could less freely ask their doctor questions (8% vs. 2%, p < 0.001) and that doctors had previously experimented on them without their consent (58% vs. 25%, p < 0.001). African American participants expressed lesser WTP than white participants after controlling for racial differences in age, sex, socioeconomic status and cardiovascular disease risk profiles (multivariable odds ratio [OR], 0.57; 95% confidence interval [CI], 0.39-0.85). The impact of race was attenuated and nonsignificant after adjustment for potential mediating factors of racial differences in medical researcher distrust and perceived risk of harm (explanatory model OR, 0.84; 95% CI 0.54-1.30). In summary, African American participants expressed markedly greater concerns about experiencing harm from participation in clinical trials and distrust toward medical researchers than white participants. These factors, in turn, appear to explain much of the resistance among African American persons to participate in clinical trials compared to white persons.

Sex differences in perceived risks, distrust, and willingness to participate in clinical trials: a randomized study of cardiovascular prevention trials.

BACKGROUND: Multiple sex differences exist in cardiovascular disease burden and treatment efficacies; adequate participation of both sexes is crucial to clinical research. METHODS: A multicenter, double-blind, randomized study evaluated sex and trial scenarios on willingness to participate (WTP) in cardiovascular prevention trials and examined sex differences in perceived risks and distrust. Hypothetical trial scenarios randomized multifactorial vignettes of adverse effects, trial durations, sponsors, financial incentives, and conflicts of interest. RESULTS: With 783 participants across 13 clinical centers, women showed lower distrust of medical researchers, perceived greater risk of myocardial infarction, and perceived greater risk of harm from trial participation than men. Men had 15% greater WTP than women (33.1% vs 28.7%; relative risk [RR], 1.15; 95% confidence interval [CI], 1.02-1.31); adjusting for explanatory mediators, we found that sex differences in perceived risks and benefits explained the sex gap in WTP. Although greater perceived probability of harm (RR, 0.41; 95% CI, 0.23-0.72), health benefit (RR, 2.99; 95% CI, 1.63-5.46), and quality of care (RR, 1.71; 95% CI, 1.12-2.61) strongly predicted WTP (for perceived probabilities >or=80% vs <20%) similarly in both sexes, and perceptions of distrust and myocardial infarction risk predicted WTP differently between sexes (P

Autoimmune disorders: nail signs and therapeutic approaches.

Systemic sclerosis (scleroderma, SSc) is an autoimmune disease that targets small and medium-sized arteries and arterioles in the involved tissues, resulting in a fibrotic vasculopathy and tissue fibrosis. Several prominent nail and periungual changes are apparent in scleroderma. Examination of the nail fold capillaries can reveal the nature and extent of microvascular pathology in patients with collagen vascular disease and Raynaud's phenomenon. Among the complications stemming from Raynaud's phenomenon can be painful ischemic digital ulcers. This can be managed, and potentially prevented, through pharmacologic and nonpharmacologic means. Whereas oral calcium channel blockers remain the most convenient therapy, oral endothelin receptor antagonists and intravenous prostaglandins may be important therapeutic advances for ischemic digital vascular lesions.