What's hot?
What's hot
July 25, 2019
In this monthly column, members of Dermatology World's Editorial Advisory Workgroup identify exciting news from across the specialty.
Edward W. Cowen, MD, MHSc
In a recent study published in the Journal of the American Medical Association, investigators at the U.S. Food and Drug Administration administered four topical sunscreens (avobenzone, oxybenzone, octocrylene, and ecamsule) in different preparations (spray, lotion, and cream) to 75% body surface area of healthy volunteers four times a day for four days (maximal use conditions). Regardless of the sunscreen or preparation, all participants in the study had detectable plasma levels of sunscreen above 0.5 ng/ml within one day of sunscreen use (doi:10.1001/jama.2019.5586).
This report has already garnered significant media attention. However, it is important that patients understand that this study did not reveal evidence of harm from sunscreen absorption. Rather, it demonstrated that the plasma level of sunscreens under these study conditions exceeded the maximum level (0.5 ng/ml) which the FDA allows for waiver of nonclinical toxicology studies (e.g., systemic carcinogenicity studies). This threshold level is somewhat arbitrary, and — as the authors note — it approximates the level of potential carcinogenic risk of an unknown compound that would be <1:100,000 in a single dose. Indeed, the concluding statement of the paper is “these results do not indicate that individuals should refrain from the use of sunscreen.”
Nonetheless, in light of this report, patients will likely ask for specific guidance on topical sunscreen use. It is clear that more work needs to be done to understand the risk of sunscreen absorption. Patients should also understand that the plasma levels reached in this study were under maximal application conditions and study participants were not exposed to heat, sunlight, or other environmental factors. Lastly, titanium and zinc oxide were not evaluated in this study, but both mineral compounds are considered by the FDA to be generally safe and effective.
Deepti Gupta, MD
Sinecatechins ointment is a green tea derivative that has been approved for the treatment of anogenital verrucae (AV) in immunocompetent adults and has been reported to be effective in treating extragenital verrucae as well. Sinecatechins has been looked at for treatment of warts in children with both anogenital and extragenital verrucae and found in a case series to have 66.7% (16/24) partial resolution and decreased size of warts and 16.7% (4/24) of patients with complete resolution of warts with median treatment duration of 4.5 months (Pediatric Dermatology. 2019; 36: 121124). Adverse side effects were limited to mild local irritation in 30% of patients.
Recently, an article in Pediatric Dermatology compared sinecatechins 15% ointment applied BID to imiquimod 5% cream applied three times a week for AV in children (https://doi.org/10.1111/pde.13881). Both imiquimod 5% cream (24% complete response, 29% partial response, 49% no response) and sinecatechins 15% ointment (56% complete response, 33% partial response, 11% no response) showed a moderate effect, but there was a greater effectiveness with sinecatechins with 89% of children experiencing complete or partial resolution of AV. Combination therapy with one or more of the following therapies: podophyllin, cimetidine, candida antigen injections, and HPV vaccine, did not significantly increase effectiveness of topical therapies. Treatment with imiquimod and sinecatechins together also did not show greater effect. Average duration of therapy was 3.6 months in the sinecatechins group and 3.2 months with imiquimod. Sinecatechins may be an effective and tolerable topical treatment option for AV in children.
Michel McDonald, MD
Does the current health care business model rely on exploiting the professionalism and inherent dedication of physicians and nurses? That is the issue addressed in a recent op-ed article in the New York Times by Danielle Offri.
According to the article, physicians make the choice to put patient care first often at personal cost to themselves. One example is that you are at your child’s recital and an elderly patient’s son needs to speak to you urgently. This is not an unfamiliar scenario, and it is why we went into medicine: to help others. Is that professionalism being manipulated in the new era of corporate medicine? As the electronic health record has become standard, some physicians spend two hours of typing for every hour of patient care. The author postulates that if 30% more work was added to a factory line without new resources, it would grind to a halt. It asks us to imagine lawyers doing 30% more work for no more pay. For doctors, not finishing the loop of taking care of patients and charting is unthinkable. Also, the article outlines a staggering statistic that the number of health care administrators increased 3200% from 1975 to 2010. Is that the best allocation of limited health care funds? Is the one endless resource the willingness of medical staff to do the right thing? This article provokes thinking about this subject, especially in the context of rising levels of physician burnout.
CDR Josephine Nguyen, MD, HCDS
The FDA is asking industry for more safety data to determine two things: to what extent skin absorbs sunscreen ingredients, and whether absorbing sunscreen has any effects on the body.
Historically, topical treatments were believed to not result in clinically relevant systemic drug absorption. Over time, with the advances in analytical methods and the recognition of systemic absorption of topically applied OTC products, the FDA started to request pharmacokinetic (PK) trials under maximal-use conditions. For any topical product developed under the New Drug Application process, this information is now a required part of the systemic safety evaluation.
The FDA is requiring maximal usage trials (MUsT) for 12 chemical sunscreen filters to evaluate whether, and the extent to which, they are absorbed into the body. While MUsT is not representative of real-world sunscreen use, the FDA explained that if the labeled use is determined to be GRASE (generally recognized as safe and effective), then consumers who use sunscreen in a lower volume would still be using it safely. Additionally, the FDA is requesting animal study models to determine if there are any reproductive and developmental adverse effects and carcinogenicity. Industry is contesting the safety requirements set forth by the FDA, arguing MUsT is not representative of real-world use, among several other reasons, and is working to meet with the FDA to discuss the requirements.
Currently, sunscreens with broad-spectrum labels must have a critical wavelength of equal to or greater than 370 nm. The critical wavelength is the wavelength at which the sunscreen allows 10% of the rays to penetrate. The FDA is proposing an additional requirement: For a sunscreen to pass the broad-spectrum test, the sunscreen product must show that it provides a UVA I/UV ratio of 0.7 or higher. The testing procedure would stay the same. The FDA would require that all sunscreen products with an SPF 15 or higher meet this revised broad-spectrum test, to ensure that consumers have adequate UVA protection given the increasing evidence of the harmful effects of UVA. If the proposed revised broad-spectrum test is not satisfied, then the product would not be GRASE.
The AADA is focusing on robust communication efforts to ensure Americans understand that sunscreen is safe, and that the public continues to use sunscreen and practice other sun-protective measures.
