Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients.

BACKGROUND: Recent publications have suggested an increased risk of delayed adverse events (DAEs) with a smooth, cohesive 20-mg/mL hyaluronic acid filler, Juvéderm Voluma (HA-V). OBJECTIVE: To examine the occurrence of HA-V DAEs and identify patterns and characteristics. METHODS: Charts from patients who received HA-V between February 1, 2009, and February 28, 2018 from 2 clinics were analyzed. RESULTS: In 4500 patients who received 9324 treatments with HA-V, 44 DAEs were identified, for a combined incidence of 0.98% per patient, 0.47% per treatment, and 0.23% per syringe. Patients with DAEs received a slightly larger cumulative amount of HA-V than those who did not. Delayed swelling and nodule formation were the most common reactions and occurred a median of 4 months after treatment, with an increase in frequency between October and January. About a third were preceded by an identifiable immunologic stimulus. DAEs were transient and resolved without incident. LIMITATIONS: The retrospective nature made it difficult to capture time to resolution or remember potential triggers. CONCLUSION: In this large, long-term, retrospective review, HA-V DAEs occurred at a rate of 0.98% per patient. Although the exact cause has yet to be elucidated, we hypothesize that an increase in fragmentation during the HA-V degradation process may trigger an inflammatory response after an immunologic trigger.

Ten-Year and Beyond Follow-up After Treatment With Highly Purified Liquid-Injectable Silicone for HIV-Associated Facial Lipoatrophy: A Report of 164 Patients.

BACKGROUND: Highly purified liquid-injectable silicone (LIS) has been established as a permanent agent for off-label correction of HIV-associated facial lipoatrophy (HIV-FLA). However, controversy exists about long-term safety. OBJECTIVE: To establish the safety and efficacy at 10 years or greater of LIS for HIV-FLA. METHODS: Patients from 3 practices with 10-year or greater in-person office follow-up were analyzed to determine the number of LIS treatments and total volume required to achieve optimal correction. The nature of any treated adverse events was noted. RESULTS: One hundred sixty-four patients had 10-year or greater in-office follow-up. All subjects maintained long-term correction with an average of 9 treatments, average of 1.56 mL per treatment, and an average total of 14.1 mL. Two patients had severe adverse events manifesting as temporary facial edema. Four patients experienced mild-to-moderate excess fibroplasia presenting as perceived overcorrection, and 6 patients had nondisfiguring subcutaneous firmness. All adverse events were successfully treatable, mostly with intralesional 5-fluorouracil and triamcinolone. CONCLUSION: Liquid-injectable silicone is an effective long-term treatment option for HIV-FLA. When injected in small quantities with the microdroplet serial puncture technique at monthly or greater intervals, optimal correction appears durable for more than 10 years. Adverse events consisted mostly of excess fibroplasia and were treatable.

Recognition of skin cancer and sun protective behaviors in skin of color.

Sun protective behaviors are not as frequently practiced in skin of color as they are amongst Caucasians.1 Thus providing a reasonable assumption this behavior, or lack thereof, increases the risk of skin cancer in this skin of color populations. The aim of this study was two-fold-- the first was to understand whether patients with skin of color, when categorized by ethnicity or skin type, are able to recognize skin cancer lesions. The second was to examine the correlation between ethnicity and/or skin type and practice of sun protective behaviors. We surveyed 105 respondents presenting for various skin problems in a dermatology office in Chicago, IL. Topics covered in the survey included recognition of skin cancer appearance and choice of sun protective behaviors. We show that there is a tendency for patients to potentially recognize atypical pigmented lesions when they are "dark moles with irregular borders" or "new moles". In contrast, there is a reduced ability among darkly pigmented skin types IV to VI, to recognize non-melanoma skin cancers. We also show that in addition to ethnicity, skin type within ethnic groups may also play an influential role on the decision to protect or not protect oneself from the sun.

A randomized, controlled trial of four ablative fractionated lasers for photoaging: a quadrant study.

BACKGROUND: Fractionated technology has revolutionized laser therapy. With the success of initial devices, several fractionated lasers have appeared on the market. Claims of superiority have made device choice difficult for physicians and patients. MATERIALS AND METHODS: Twelve subjects were treated with fractionated ablative lasers (10,600-nm carbon dioxide and 2790-nm yttrium scandium gallium garnet) in this institutional review board-approved trial. Each face was divided into four quadrants, and each quadrant was randomly treated using one of four lasers. Clinical experience was used to optimize settings. Two patients submitted biopsies from each quadrant immediately after treatment. Patients and blinded investigators assessed pain during treatment and post-treatment improvement in photoaging (measured by rhytides, lentigines, texture, and pore size) using a five-point scale. RESULTS: All devices resulted in statistical improvement in photoaging in all patients, but no device was statistically significantly superior. No statistically significant difference was found in pain scores. All patients reported satisfaction 1 month after treatment. Three patients experienced adverse reactions. Histologically, there were no statistically significant differences between devices. CONCLUSIONS: Fractionated ablative lasers reliably result in improvement in photoaging. Despite marketing claims, no statistically significant differences were found in outcomes, pain during treatment, or histologic findings. Even with experienced users, significant adverse reactions are possible.

Delayed inflammatory reaction to bio-alcamid polyacrylamide gel used for soft-tissue augmentation.

BACKGROUND: Given the recent boom of the cosmetic industry, there is a wealth of new products available to patients and physicians, including soft-tissue fillers. Bio-Alcamid polyacrylamide gel (Polymekon, Milan, Italy) is a filler that has potential to cause adverse reactions. OBSERVATIONS: Two patients who had previously been treated with Bio-Alcamid outside of the United States presented with different manifestations of inflammatory responses to the product. These reactions were challenging to treat. CONCLUSIONS: Despite claims of safety, Bio-Alcamid and possibly other soft-tissue fillers available worldwide have the potential to cause adverse reactions. Physicians should be aware of the various presentations and treatment options for these reactions.

The filler revolution: a six-year retrospective.

There are currently more than 20 FDA-approved fillers in the United States (U.S.), noteworthy considering that it was only six years ago that the first hyaluronic acid filler was approved. The pace of development of filler substances in the last few years has been extremely rapid. The authors review the development, advantages, and disadvantages of fillers currently available in the U.S.

Differences in perceptions of beauty and cosmetic procedures performed in ethnic patients.

The United States has become progressively more multicultural, with the ethnic population growing at record rates. The US Census Bureau projects that, by the year 2056, greater than 50% of the US population will be of non-Caucasian descent. Ethnic patients have different cosmetic concerns and natural features that are unique. The cosmetic concerns of ethnic patients also differ as the result of differences in skin pathophysiology, mechanisms of aging, and unique anatomic structure. There is no longer a single standard of beauty. We must now adapt to the more diverse population and understand how to accommodate the diversity of beauty in the United States. Ethnic patients do not necessarily want a Westernized look because what constitutes beauty is determined by racial, cultural, and environmental influences. We as leaders in skin care must understand these differences and adapt our practices accordingly. This article will focus on the differences in aging in different ethnic populations and highlight procedures unique to skin of color.

Racial (ethnic) differences in skin properties: the objective data.

Racial (ethnic) differences in skin properties may explain racial disparities seen in dermatologic disorders and provide insight into appropriate differences in the management of these disorders. However, racial differences in skin have been minimally investigated by objective methods and the data are often contradictory. Objective methods studied include transepidermal water loss (TEWL), water content (WC), corneocyte variability, blood vessel reactivity, elastic recovery/extensibility, pH gradient, lipid content, surface microflora, microscopic evaluation of mast cell granules, and confocal microscopy. The majority of the evidence (six out of eight studies) indicates that TEWL is greater in Black skin compared with White skin. TEWL measurements of Asian skin are inconclusive as they have been found to be equal to Black skin and greater than Caucasian skin, equal to Caucasian skin, and less than all other ethnic groups in different studies. Racial differences in WC, as measured by resistance, capacitance, conductance and impedance, are also inconclusive as the data are contradictory. While the evidence regarding corneocyte desquamation is minimal, one clinically provocative observation is that Blacks have a 2.5 times greater spontaneous desquamation rate compared with Caucasians and Asians, possibly accounting for an increased frequency of xerosis seen clinically in Blacks. With regards to blood vessel reactivity, studies can not be compared to each other because each uses different vasoactive substances. However, each study, except for one study comparing Hispanics and Whites, and another comparing Japanese and German women, reveal some degree of racial variation in blood vessel reactivity. It has been demonstrated that the pH of Black skin is less than White skin; however, the studies that have demonstrated this have done so under different skin conditions and on different anatomic sites. Racial differences in lipid content are inconclusive. Additionally, there is insufficient and conflicting evidence to make conclusions regarding racial differences in skin biomechanics and skin microflora. Microscopic evaluation reveals that Black skin contains larger mast cell granules, and differences in stuctural properties and enzymes of mast cells compared with White skin, possibly accounting for differences in pruritus experienced by the individuals of these racial groups. There exists substantial evidence to support that Black skin has a higher TEWL, variable blood vessel reactivity, decreased skin surface pH, and larger mast cell granules compared with White skin. Although some deductions have been made about Asian and Hispanic skin, further evaluation needs to be done. Differences in WC, corneocyte desquamation, elastic recovery/extensibility, lipid content and skin microflora, although statistically significant, are inconclusive.

Decreasing allergic contact dermatitis frequency through dermatotoxicologic and epidemiologic based intervention?

Allergic contact dermatitis (ACD) affects millions of people worldwide. In an attempt to decrease the incidence of contact dermatitis, several countries have implemented legislations to reduce the population's exposure to known sensitizers. To determine whether these legislations have been effective, we reviewed several studies examining trends in patch test reactivity before and after implementation of these legislations. Common sensitizers studied include nickel, gluceryl monothioglycolate fragrances, chromate, and thiuram. Overall, the evidence suggests a decreasing trend of ACD with appropriate formulation changes, however some of the data may be confounded by biases, and additionally, exposure to the sensitizer may still exist via non-compliance to regulations by small manufacturers. In the future population based studies should be conducted to more accurately assess trends in ACD.