Is HPV vaccination associated with clearance of common warts?
A study published in JAADfound that the human papillomavirus (HPV) vaccine does not lead to increased clearance of common warts in young patients. Over a five-year period, 336 patients aged nine to 21 years were seen by a dermatologist for verruca vulgaris. At follow-up, 14% of patients received the HPV vaccine, while 39% were vaccinated before diagnosis and 47% were unvaccinated. The unvaccinated group had a complete response rate of 52.22%, while the group that was vaccinated during follow-up had a response rate of 54.17%, and the group that was vaccinated before diagnosis was 52.67%. Resolution rates did not vary between unvaccinated and vaccinated patients.
DermWorld Insights and Inquiries: Positively perplexing — Determining the meaning of CD30 positivity
I’ll wager that most DermWorld Insights and Inquiries readers have experienced receiving a biopsy report, obtained from an inflammatory lesion, stating “scattered CD30+ cells were observed, accompanied by a comment that “clinicopathologic correlation is necessary to rule out the possibility of a lymphoproliferative disorder.” After mumbling (or cursing) under your breath, you ponder the significance of these findings. Downplayed, a lymphoma may be missed; overplayed, unnecessary (and potentially dangerous) therapy may be administered. Keep reading!
FDA proposes new guidance on OTC sunscreen products and safety information
The FDA has released a proposed administrative order that updates its over-the-counter (OTC) sunscreen monograph. The proposed order serves as a roadmap for manufacturers to bring OTC sunscreens to market and provides a pathway to finalize outstanding questions about safety and labeling of sunscreen ingredients.
The proposed order “is essentially a ‘rulebook’ for OTC sunscreen products in the future,” said Academy President Kenneth Tomecki, MD, FAAD, in a MedPage Todayarticle. “It builds upon the labeling and testing requirements in the current ‘rulebook’ that sunscreen manufacturers will need to meet in the future. And this is a good thing! It means that the FDA is proactively taking steps to ensure the continued safety and efficacy of sunscreens and working to clarify confusion around sunscreen labels.”
The proposed order largely reflects what was outlined in the 2019 proposed rule on sunscreen. Highlights include:
Maximum labeled SPF value should be SPF 60+ while permitting the marketing of sunscreen products formulated with SPF values up to 80.
Sunscreens containing zinc oxide and titanium dioxide were deemed generally recognized as safe and effective (GRASE).
Aminobenzoic acid (PABA) and trolamine salicylate are not GRASE due to safety issues.
Cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone are not GRASE because more data is needed to make a GRASE determination.
All sunscreens with SPF values of 15 and above must satisfy broad spectrum requirements.
Updates proposed to sunscreen product labels, including an alphabetical listing of the active sunscreen ingredients in the product.
Sunscreen-insect repellent combinations are not GRASE due to inconsistencies in testing methods between FDA and the Environmental Protection Agency.
The FDA also issued a deemed final order, which outlines all existing FDA regulatory guidance on sunscreens, dating back to the final rule released in 1999 that was never implemented, and the 2011 labeling rules for sunscreens. This release was required by the Coronavirus Aid Relief and Economic Security Act and simply establishes what the current sunscreen requirements are. The proposed administrative order would modernize these established requirements with the latest science and research, and once finalized, will supersede these previous actions.
Academy advocacy
This proposed administrative order is not final, and the Academy, industry, and other stakeholders will have the opportunity to comment on the proposed guidance.
Resources for physicians and the public
The Academy has released a media statement and will develop talking points to assist members when answering questions from patients. The Academy will also develop educational resources to help the public navigate the implications of the FDA's proposed order.
FDA approves first topical JAK inhibitor for atopic dermatitis
On Sept. 21, the U.S. Food and Drug Administration (FDA) approved topical ruxolitinib (Opzelura) for the treatment of non-immunocompromised patients with mild to moderate atopic dermatitis (AD) ages 12 years and older. Ruxolitinib cream is the first and only topical formulation of a JAK inhibitor approved in the United States. The cream received approval for short-term, noncontinuous treatment of moderate-to-severe AD that has not been adequately controlled with topical prescription therapies or when those therapies are not advisable. The labeling includes boxed warnings for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, seen with oral JAK inhibitors for inflammatory conditions.
The drug’s approval was based on results from two phase 3 clinical trials, which involved a combined total of more than 1,200 adults and adolescents with moderate-to-severe AD. In the trials, patients with an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%-20% of affected body surface area were randomized to twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for eight weeks. The 1.5% concentration was approved by the FDA.
More than half of patients randomized to ruxolitinib cream met the primary endpoint as compared with 15.1% and 7.6% of patients in the control groups. Additionally, more than half of patients in the ruxolitinib groups had clinically meaningful reductions in itch versus 15-16% of patients randomized to vehicle.
The potential FDA approval of multiple JAK inhibitors could offer new treatment options for dermatology patients. Read more in DermWorld.
COVID-19 infection in a vaccinated health system
A recent letter to the editor in the New England Journal of Medicine shared the experience of a dramatic increase in COVID-19 infections in December 2020 at the University of California San Diego Health (UCSDH). By March, 76% of the UCSDH workforce was fully vaccinated, and by July, 87% were fully vaccinated. Between March and June, fewer than 30 health care workers tested positive each month. However, after the end of California’s mask mandate on June 15 in conjunction with the rise in the delta variant, infections rapidly increased, including cases among fully vaccinated persons.
From March 1 to July 31, 2021, a total of 227 UCSDH health care workers tested positive for COVID-19 by RT-qPCR assay of nasal swabs, 57% of which were fully vaccinated. Symptoms were present in 109 of the 130 fully vaccinated workers (84%) and in 80 of the 90 unvaccinated workers (89%). The seven remaining workers were partially vaccinated. Vaccine effectiveness exceeded 90% from March through June but fell to 65.5% in July. In workers completing vaccination in January or February, the attack rate was 6.7 per 1,000 persons, whereas the attack rate was 3.7 per 1,000 persons among those who completed vaccination during March through May. Among unvaccinated persons, the July attack rate was 16.4 per 1,000 persons.
The American Academy of Dermatology is a non-profit professional organization and does not endorse companies or products. Advertising helps support our mission.
