Recent Developments

New AAD Survey Reveals Many Americans Recognize UV Risks, Misunderstand How to Protect Themselves

In a recent survey of more than 1,000 US adults, the American Academy of Dermatology (AAD) found that while respondents gave themselves high ratings for sun protection and most reported that sun protection is more important to them now than it was five years ago, there’s a lot they don’t know about how to protect themselves from the sun and the risks of sun exposure, including skin cancer. To address these misconceptions, the AAD kicked off its annual SPOT Skin Cancer campaign on Melanoma Monday (May 2) during Skin Cancer Awareness Month to encourage Americans to #PracticeSafeSun since unprotected UV exposure is the most preventable risk factor for skin cancer.

According to the survey, 62 percent of respondents gave themselves an overall grade of excellent or good for sun protection in 2021, yet 63 percent reported getting a tan, an increase of nine percentage points from 54 percent in 2020. One-third of respondents (33 percent) reported getting a sunburn, an increase of eight percentage points from 2020.

The survey also revealed:

• 67 percent incorrectly believe that SPF 30 sunscreen offers twice as much protection as SPF 15 sunscreen.
• 65 percent say they often forget to reapply sunscreen.
• 43 percent are unaware that shade protects a person from UV rays.

Helping patients understanding what SPF measures and the difference between SPF numbers is an important step in sun protection. A sunscreen’s SPF number indicates how much UVB light (the burning rays) a sunscreen can filter out. While a sunscreen with an SPF 15 filters out 93 percent of the sun’s UVB rays, a sunscreen with an SPF 30 filters out 97 percent of the sun’s UVB rays.

Patients should also be counseled to seek shade, wear sun-protective clothing, apply a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher to all skin not covered by clothing. Broad-spectrum sunscreen provides protection from both UVA and UVB rays.

To help the public protect themselves from the sun, the AAD has awarded 20 shade structure grants to public schools and non-profit organizations this year for the installation of permanent shade structures for outdoor locations that are not protected from the sun, such as playgrounds, pools, or recreation spaces. Since 1999, the AAD’s Shade Structure Grant Program has awarded 480 shade structure grants that protect an estimated 3.6 million children and adults from overexposure to the sun each day.

The AAD also offers a youth education program, Good Skin Knowledge, which teaches young people the facts about common skin, hair, and nail conditions. This year, the AAD awarded 40 Good Skin Knowledge community grants to underserved communities.

Sun Hero Program GeArs up for Skin Cancer Awareness Month

Just ahead of Skin Cancer Awareness month, the Sun Hero Program (beasunhero.com) celebrated its launch at the Annual Meeting of the AAD in Boston in March. Dermatologist Amy Brodsky, MD launched Sun Hero in conjunction with L’Oreal skincare brands CeraVe and La Roche-Posay. She appeared holographically at the L’Oreal booth at the AAD meeting to describe the initiative, designed to expand UV safety education for youths across the country.

The program, conceived by Dr. Brodsky, is intended to empower dermatologists to bring UV safety education to young people in schools, camps, and other community programs. The goal is to encourage early adoption of safe behviors to reduce skin cancer risks. As COVID-19 restrictions lift across the US, opportunities to educate in person are expected to increase, Dr. Brodsky suggests.

The Sun Hero program offers dermatologists templates for making outreach to schools and other organizations. The program provides students nationwide a fun and unique way to learn about the importance of sun protection and provides free Sun Hero kits to students that feature age-appropriate sun-safety resources (sunscreen samples, a comic book, a sun sensor bracelet, sun hero stickers, and fact sheets).

Educational materials and the curriculum were developed by Dr. Brodsky and her team of medical professionals. She says that reponse to the program has been enthusiastic and that she looks forward to its continued growth. And she commends L’Oreal brands for their support of the initiative.

Next month, Dr. Brodsky and her team will be at Wrigley Field for Sun Safety Day, sponsored by CeraVe, as an extension of the Sun Hero Program. The day will be highlighted by public service announcements about sun safety and UV protection, sunscreen giveaways, and more.

Dove Survey: Half of All Girls Say Beauty Advice on Social Media Causes Low Self-Esteem

Two in three girls in the US are spending more than an hour each day on social media. Beauty advice fills their feeds, but it is not all positive. In fact, one of two girls say idealized beauty content on social media causes low self-esteem, according to The Dove Self-Esteem Project research.

The majority of girls realize that less time on social media and taking control of what they scroll, is part of the solution. In fact, seven in 10 girls felt better after unfollowing idealized beauty content on social media.

For years, Dove has championed wider definitions of beauty and has taken action toward making social media a more positive place with campaigns like #SpeakBeautiful, #NoDigitalDistortion and Reverse Selfie/Selfie Talk.

Now, the Dove Self-Esteem Project is launching the #DetoxYourFeed campaign to empower teens to define their own beauty standards and choose their own influences by inviting them to unfollow anything that doesn’t make them feel good about themselves.

Through a series of films, educational content, and partnerships with inspiring voices, the campaign encourages necessary conversations between parents, caregivers, and teens about the dangers of toxic beauty advice.

In a longform campaign film, Toxic Influence, moms and their teens engage in a dialogue around harmful beauty advice on social media. The film highlights dangerous topics like “fitspo,” “thinspo” and the promotion of elective cosmetic procedures to young girls.

Findings show that 80 percent of girls would like their parents to talk to them about how to manage idealized beauty posts, so the Dove Self-Esteem Project has developed academically-validated resources and tools to help parents navigate important conversations with their kids and empower teens to #DetoxYourFeed.

To help spread the #DetoxYourFeed message, Dove is partnering with Gabrielle Union and Zaya Wade to remind everyone that the power to curate your feed and overall experience with social media is in your hands.

FDA Cracks Down on OTC HQ Products

FDA is cracking down on over-the-counter (OTC) skin lightening products containing hydroquinone (HQ) that do not meet the requirements to be legally sold as OTC drugs.

The administration issued warning letters to 12 companies explaining that all OTC skin lightening products require an FDA-approved new drug application before they can be legally marketed. These products are not generally recognized as safe and effective (not GRASE). FDA has received reports of serious side effects including skin rashes, facial swelling, and ochronosis from the use of skin lightening products containing HQ.

The companies were given 15 days to fix any violations outlined in the warning letters and tell FDA what actions they’ve taken to address violations.

Some manufacturers and distributors have already removed their OTC skin lightening products from the marketplace, and FDA plans to take action against those continuing to market these potentially harmful and illegal OTC products. Currently, Tri-Luma is the only FDA-approved drug containing hydroquinone.

In addition to the COVID-19 response efforts, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) included important reforms that modernized the way certain OTC drugs are regulated. Since enactment of the CARES Act, OTC skin lightening products containing hydroquinone are deemed to be new drugs and are misbranded. All OTC skin lightening products require an FDA approved new drug application before they can be legally marketed.

Botox Cosmetic Turns 20!

Allergan Aesthetics’ Botox Cosmetic (onabotulinumtoxinA) turned 20 on April 15, 2022, marking 20 years since the FDA first approved the product to temporarily improve the look of moderate to severe glabellar lines. It was the first product of its kind and has since received two additional aesthetic indications—in 2013 and 2017—making Botox Cosmetic the first and only neurotoxin that is FDA-approved for adults to temporarily improve the look of moderate to severe lines in three areas; frown lines, crow’s feet and forehead lines.

In honor of the 20-year milestone, Botox Cosmetic launched a documentary style video spotlighting real patients and providers. Real patients share how and why they continue to see Botox Cosmetic as a treatment for someone like them. Botox Cosmetic continues to celebrate its muses in all their forms, genders, and colors. You can watch the video at www.botoxcosmetic20thcelebration.com and @BotoxCosmetic on social.

CLOSE UP with Karl Lewis, MD

Until recently, there wasn’t much that doctors could offer patients with metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to hedgehog pathway inhibitors (HHI). This changed when the FDA gave its nod to the PD-1 inhibitor Libtayo (cemiplimab-rwlc) for these patients in February 2021. Here, Karl Lewis, MD, a professor in the division of medical oncology at the University of Colorado in Aurora, discusses the results from a continuation of the EMPOWER-BCC 1 study, which formed the basis of the FDA’s approval. These findings were recently presented at American Association for Cancer Research (AACR) Annual Meeting.

Why is this topic important to study?

Karl Lewis, MD: Basal cell carcinoma (BCC), a form of non-melanoma skin cancer, is the most common type of skin cancer in the US, with approximately 2.8 million cases each year, leading to more than 3,000 deaths annually. While most BCC cases are caught early and cured with surgery and radiation, a small proportion of tumors can become advanced and penetrate deep into surrounding tissues (locally advanced) or spread to other parts of the body (metastatic), which is more difficult to treat.

For some of these advanced cases, surgery and radiation may no longer be curative, and patients may receive a class of medicines called hedgehog pathway inhibitors (HHIs), which are approved for the treatment of patients with locally advanced BCC or metastatic BCC who are not candidates for surgery or radiation.

While effective for some, many patients may discontinue HHI therapy due to progressive disease or intolerance to adverse events and will require another treatment. Until recently, there were no approved agents for the treatment of BCC in patients who experienced progression of disease on HHI therapy or who were intolerant to prior HHI therapy.

Libtayo (cemiplimab) is the first and only immunotherapy treatment to show a clinical benefit in patients with metastatic disease following HHI therapy or for whom an HHI is not appropriate in a pivotal trial. In February 2021, cemiplimab was granted accelerated approval by the FDA in the metastatic BCC indication based on an interim analysis showing the impact of treatment with cemiplimab on tumor response rate and durability of response. Full approval for this indication may be contingent upon verification and description of clinical benefit.

Describe the research and your findings.

Dr. Lewis: This research is a continuation of the EMPOWER-BCC 1 study, which formed the basis of the February 2021 FDA approval of cemiplimab for the treatment of locally advanced BCC and metastatic BCC in patients previously treated with an HHI or for whom an HHI is not appropriate. EMPOWER-BCC 1 is an open-label, multicenter, non-randomized Phase 2 trial (Study 1620), of patients with metastatic BCC (nodal or distant) who progressed on or were intolerant to HHI treatment.

This study included 54 patients with metastatic BCC who received 350 mg of cemiplimab intravenously every three weeks for up to 93 weeks or until disease progression occurred, following HHI treatment.

Results demonstrated that cemiplimab provided clinically meaningful antitumor activity, including durable responses, in this patient population. Specifically, the confirmed overall response rate per independent central review (ICR) was 24.1 percent (95% confidence interval [CI]: 13.5–37.6), with 1 complete response and 12 partial responses. Among responders, the median time to response was 4.0 months (range: 2.0−10.5) per ICR. The estimated median duration of response per ICR was 16.7 months (95% CI: 9.8–not evaluable [NE]). Median overall survival was not reached (95% CI: 25.7–NE), but the 12-month Kaplan-Meier estimation of overall survival was 84.4 percent (95% CO, 71.3–91.9). Median Kaplan-Meier progression-free survival was 8.3 months (95% CI: 4.2–15.9) per ICR.

The safety profile was generally consistent with that previously described for cemiplimab and other PD-1 inhibitors. Specifically, the most common treatment-emergent adverse events of any grade were fatigue (42.6%; n=23), diarrhea (37.0%; n=20), constipation (22.2%; n=12) and hypertension (20.4%; n=11). Immune-related adverse events of any grade occurred in 61.1 percent (n=33) of patients. Grade ≥3 immune-related adverse events were seen in 9.3 percent (n=5) of patients, with the only Grade ≥3 immune-related adverse event occurring in more than one patient being colitis. Two patients (3.7%) had a serious treatment-emergent adverse event resulting in death, including one patient with staphylococcal pneumonia and one with hemoptysis.

These results complement those previously reported for the locally advanced BCC cohort, and together indicate that cemiplimab is highly active in advanced BCC tumors.

What is the next step?

Dr. Lewis: Cemiplimab is continuing to be studied in this patient group as part of the ongoing phase 2 EMPOWER-BCC 1 study. Updates will be submitted to the FDA accordingly.

“It has been remarkable to see how Botox Cosmetic has evolved in 20 years, one scientific study at a time that showcases the clinical significance of this treatment,” says Dr. Jean Carruthers, MD, FRCSC, FRC (Poth), in a news release. “ Botox Cosmetic has not only changed the trajectory of my career but also the way the medical aesthetics community practices and teaches. By any account, two decades is a long time, however in medicine it is just the beginning, and I look forward to the next big milestone for Botox Cosmetic.”

New Survey Reveals Negative Impact of Psoriasis on Mental Health

Arcutis Biotherapeutics, Inc. recently shared findings from Skin Insights: Uncovering Psoriasis Survey, a national survey of 507 adults 18+ diagnosed with plaque psoriasis who are on topical treatments. The online survey was conducted by The Harris Poll and was designed to reveal insights into the emotional impact of the disease and challenges related to currently available topical treatments.

The survey was conducted among 507 adults (18+) in the US with psoriasis who use topical treatments but are not on biologics. Of the 507 people surveyed, a subset of 320 respondents reported having psoriasis in intertriginous areas at some point in time.

When asked about what they wished for when it came to using topical treatments, among all people surveyed:

• 90 percent wish there were more effective topical treatment options
• 90 percent wish they could use a single therapy anywhere on their body
• 81 percent wish they had more topical treatment alternatives to steroids
• 68 percent want a product that provides both improvement in plaques and itch relief.

Additionally, of respondents with psoriasis in intertriginous areas, 52 percent said they needed to use different topical treatments for different parts of their body, and described doing so to be time consuming (54 percent), expensive (40 percent), and frustrating (38 percent).

The survey’s finding that 64 percent of respondents have experienced psoriasis in intertriginous areas at some point in time is significantly higher than past epidemiological studies have suggested. Two in five survey respondents with psoriasis in intertriginous areas (40 percent) did not recognize they had intertriginous psoriasis symptoms until they saw pictures of intertriginous plaques.

Psoriasis in intertriginous areas can have a profoundly negative emotional and sexual impact. Respondents said dealing with psoriasis in these areas affected their wellbeing, including making them feel embarrassed (80 percent), anxious (79 percent), and depressed (69 percent). Nearly half of those with psoriasis in intertriginous areas (45 percent) reported a strong or very strong negative impact on sexual distress/anxiety, with more than a third reporting a negative impact on intimate relationships (39 percent) and sexual function (37 percent).

Most individuals with intertriginous psoriasis do not show their health care provider psoriasis in intertriginous areas of their body, suggesting a need for more dialogue between patients and their health care providers about the occurrence of psoriasis in intertriginous areas and treatment options.