Recent Developments

FDA Greenlights Restylane Lyft for Hand Rejuvenation

Restylane Lyft is the first hyaluronic acid (HA) injectable gel approved for use on the dorsal hands of people older than 21, thanks to recent FDA approval.

Radiesse (Calcium Hydroxylapatite) is also approved for the correction of lost volume in hands.

“As we age, we lose volume in the back of the hands, causing the appearance of tendons, wrinkles and veins to become more pronounced,” says Ellen Marmur, MD a board-certified dermatologist in New York City and clinical trial investigator for Restylane Lyft in the hands. “Many of my patients start to notice their youthful-looking faces aren’t matching their aging hands, and ask me what they can do about it. I am now pleased to be able to offer them Restylane Lyft.”

Actual user*. Individual results may vary. Treated with 3mL of Restylane Lyft in the left hand. 4 weeks after treatment. *user = clinical trial subject

The FDA nod was based on a multi-center, randomized, evaluator-blinded, split-hand study investigating safety and efficacy of Restylane Lyft for use in the dorsal of the hands. Eighty-nine patients age 22 and older were enrolled in the trial. The study met its primary endpoint, showing a clinically meaningful improvement in the correction of volume deficits of treated hands for up to six months. Restylane Lyft was shown to be safe and well-tolerated for the correction of volume deficit in the dorsal hand. After initial treatment, injection site responses (swelling, tenderness, redness, bruising, pain, itching, impaired hand function) were predominantly mild in intensity, and temporary.

“Restylane Lyft is now the first and only dermal filler with 3 FDA-approved treatment areas – the midface/cheek area, nasolabial folds, and now the back of the hands,” says Alisa Lask, General Manager and Vice President, US Aesthetic Business Unit at Nestlé Skin Health.

FDA Approves Cimzia for Moderate to Severe Plaque Psoriasis

The FDA has approved extending the label for UCB’s Cimzia (certolizumab pegol) to include a new indication in adults with moderate to severe plaque psoriasis. The approval makes Cimzia the first Fc-free, PEGylated anti-TNF treatment option for this indication and marks the entry of UCB into immuno-dermatology, where significant unmet need currently exists. The approval also follows a recent FDA label update for Cimzia in pregnancy and breastfeeding that provides essential information to healthcare professionals and women.

“The Phase 3 clinical development program for Cimzia in plaque psoriasis demonstrated statistically significant improvements in efficacy endpoints at week 16. A clinically meaningful response was maintained up to week 48. This compelling body of evidence is especially significant for a disease like psoriasis, which often has significant emotional and social burdens in addition to the more widely recognized physical symptoms,” says Alice Gottlieb, MD, PhD, Professor of Dermatology at New York Medical College and lead investigator, in a news release.

“Today’s approval provides patients and their healthcare professionals with a robust new biologic option that provides durable disease control,” she adds. “The two dose regimens of Cimzia also allow for patient-tailored treatment. Cimzia also demonstrated similar efficacy in both biologic-naïve patients and those previously treated with other biologics.”

Taltz Gets Label Update to Treat Psoriasis Involving the Genital Area

The FDA has approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area. Eli Lilly and Company’s Taltz is the first treatment FDA approved for moderate to severe plaque psoriasis that includes such data in its label. Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In December 2017, Taltz was also approved for the treatment of adults with active psoriatic arthritis.

The label update is based on positive results from the first randomized, double-blind, placebo-controlled study in moderate to severe psoriasis involving the genital area. In the study, 149 patients with plaque psoriasis who were candidates for phototherapy or systemic therapy, and who failed to respond to or were intolerant of at least one topical therapy for the treatment of psoriasis affecting the genital area, were treated with Taltz or placebo. Patients were required to have a minimum body surface area involvement of 1 percent, a static Physician Global Assessment (sPGA) score of ≥3 and a sPGA of genitalia score of ≥3.

Taltz demonstrated a significant improvement compared to placebo at 12 weeks in the severity of psoriasis affecting the genital area, as measured by sPGA of genitalia score; overall psoriasis, as measured by sPGA score; genital itch, as measured by the Genital Psoriasis Symptoms Scale (GPSS) Itch numeric rating scale (NRS); and in the patient-perceived impact of psoriasis involving the genital area on frequency of sexual activity, as measured by Sexual Frequency Questionnaire (SFQ) Item 2 (In the past week how often did your psoriasis involving the genital area limit the frequency of your sexual activity?) score.

Dupixent Improves Moderate to Severe AD in Adolescents

Dupixent (dupilumab) performed well in a Phase 3 Trial of inadequately controlled moderate to severe atopic dermatitis in adolescents, Regeneron and Sanofi report.

In the trial, treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, and certain health-related quality of life measures.

Dupixent is the first and only biologic to show positive results in this patient population. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of moderate-to-severe (12 to 17 years of age) and severe (6 months to 11 years of age) atopic dermatitis

Patients treated with Dupixent had significant improvement in disease severity at 16 weeks.
The primary endpoints were the proportion of patients achieving Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75 percent improvement in Eczema Area and Severity Index (EASI-75, co-primary endpoint outside of the U.S.) at 16 weeks. Dupixent’s safety profile was consistent with that seen in adults.

Detailed results from this trial will be presented at a future medical meeting. These data will be submitted to regulatory authorities later this year.

Severe AD Linked to CV Risk

Eczema now joins the list of inflammatory conditions linked to cardiovascular risk.

British researchers report that individuals with severe eczema may be at greater risk for heart attack, stroke and atrial fibrillation. Their study appears in the BMJ.

Specifically, individuals with severe eczema had a 20 percent increased risk of stroke and a 40 percent to 50 percent greater risk of unstable angina, heart attack, atrial fibrillation, and death from heart disease. This group also had a 70 percent increased risk for heart failure, the study showed. These risks remained after the researchers accounted for such factors as weight, smoking, and alcohol use.

Still, this was an observational study, so the researchers couldn’t prove cause and effect.

To arrive at their findings, the researchers compared data for more than 385,000 adults (average age 43) with eczema to up to five people of similar age and gender who didn’t have eczema. Patients were classified as having mild, moderate or severe eczema and followed for an average of five years.

In an accompanying editorial, Dr. John Ingram, a consultant dermatologist at Cardiff University in Wales, writes that the new study “makes the case for targeted screening of standard CV disease risk factors. We may need to rethink thresholds for primary prevention interventions in this patient group, by factoring in severe eczema as an independent CV disease risk factor.”

New Guidelines May Increase Accuracy of Melanoma Diagnoses

New guidelines may slightly increase reliability and accuracy of melanoma diagnoses, a new study in JAMA Network Open shows. The American Joint Committee on Cancer recently updated its guidelines for melanoma, and the study researchers found that when pathologists used the new guidelines for cases of early stage invasive melanoma, they agreed with an expert-defined diagnosis 10 percent more often.

In the study, researchers reviewed 4,342 analyses of 116 cases of invasive melanoma, made by a total of 187 pathologists from 10 US states.

Image from The BMJ.

Two different resolutions of a scan showing a category 3 melanoma in situ common, as agreed upon by three expert pathologists

The physicians’ interpretations were compared with an expert consensus diagnosis to assess accuracy. The pathologists were unaware that they were interpreting the same set of cases twice; the second viewing occurred at least eight months after the first.

In a prior study, the same researchers showed that pathologists disagreed about the diagnosis of early-stage invasive melanoma more than 50 percent of the time, and they wanted to learn if the new guidelines would lead to more reliable diagnoses.

Now, pathologists may be able to more accurately classify invasive melanoma using the new guidelines. Although there was only slight improvement in how often pathologists agreed on characterizing invasive melanoma, that difference could help improve treatment outcomes for some patients.

Still, the likelihood that pathologists will agree on the diagnosis of early-stage melanoma tissue and make an accurate diagnosis is low.

Spironolactone May Be Alternative to Antibiotics in Female Acne

The drug spironolactone may be just as effective as antibiotics for the treatment of women’s acne, report researchers from the Perelman School of Medicine at the University of Pennsylvania.

The study, published in the Journal of Drugs in Dermatology, found patients who were originally prescribed spironolactone changed to a different drug within one year at almost the same rate as those who were prescribed antibiotics. The prescription change is a proxy for ineffectiveness, since switching is often the result of treatment failure due to lack of efficacy, side effects, cost, or other factors.

Oral antibiotics are the most common systemic treatment for acne, and when combined with the large patient population, the result is that dermatologists prescribe the highest level of antibiotics per provider among all medical specialties, according to the Centers for Disease Control—a fact that contributes to concerns about increased resistance to antibiotics across all fields of medicine.

“It’s clear that a safe alternative to oral antibiotics could have a huge benefit, and our data show spironolactone may be that alternative,” says the study’s lead author John S. Barbieri, MD, MBA, Dermatology chief resident at Penn, in a news release. David J. Margolis, MD, PhD, a professor of Dermatology, was the study’s senior author.

To arrive at their findings, researchers compared data on 6,684 females taking spironolactone to 31,614 who were prescribed antibiotics. Within a year, 14.4 percent of spironolactone patients and 13.4 percent of antibiotic patients had switched to alternative treatments, suggesting each treatment was working at almost the same rate, despite the fact that tetracycline-class antibiotics are prescribed five times as frequently.

“These numbers suggest dermatologists should consider spironolactone first instead of antibiotics when it comes to women with acne,” Dr. Barbieri says.

In addition to the benefits for antibiotic stewardship, Dr. Barbieri pointed to several studies showing long-term oral antibiotic use may be associated with antibiotic resistance, lupus, inflammatory bowel disease, and even colon and breast cancer.

“This indicates spironolactone may have a better safety profile than oral antibiotics, which is another factor that makes it such an appealing option,” Dr. Barbieri says. He also noted spironolactone is less expensive, which may be relevant to patients with high deductibles or who are uninsured.

Spironolactone is not FDA-approved for the treatment of acne despite expert opinion supporting its use, and Barbieri says the findings of this study should be confirmed by a randomized controlled trial that directly compares the two treatment options.

Skin Cancer Tops Procedure List

More than 3.5 million skin cancer procedures were performed by ASDS members in 2017—a 33 percent increase since 2012. Over the last six years, treatments for melanoma have grown by 30 percent. For the first year, sun damage took the top spot for the condition treated with energy-based devices. This reinforces the ongoing need for sun protection education, especially for younger patients. Developing sun-safe behaviors in youth will lead to healthier habits for life. The SUNucate model legislation created by ASDSA has taken hold and currently 14 states have passed laws allowing children to use over-the-counter sunscreen at school and camps.

“These increasing stats reinforce the ASDS mission to take a comprehensive approach for promoting sun-safe behaviors, encouraging skin cancer screenings and providing leading cost-effective treatment options to ensure the best quality outcomes,” says Dr. Donofrio. “Being part of the treatment and healing process for millions of patients motivates our mission for prevention and early detection efforts.”

The ASDS also reported that the number of cosmetic procedures performed annually has continued to grow.

The top cosmetic treatments in 2017 were:

• 3.2 million procedures using laser, light and energy-based devices
• 2.1 million neuromodulators
• 1.6 million soft-tissue fillers
• 485,000 chemical peels
• 434,000 body sculpting treatments

Consumer Reports and EWG Release Sunscreen Rating

The Environmental Working Group (EWG) released its 12th annual Guide to Sunscreens, rating the safety and efficacy of more than 1,000 sunscreens, moisturizers and lip balms that advertise sun protection, and found that 67 percent of the products don’t work well or contain ingredients that could harm health. (Winners can be found at ewg.org.)

Despite the 2014 Sunscreen Innovation Act, the FDA hasn’t approved any new sunscreen ingredients in a decade. Sunscreen products are capped at SPF 50 in Europe and Japan, and 50+ in Canada and Australia. Capping SPF claims is one important way the FDA could improve consumer protection in the US. EWG estimates that half of all sunscreens on the US market would not pass the more stringent European ingredient standards, which require stronger UVA protection.

The annual Consumer Reports sunscreen ratings have also been released. Just one product, La Roche-Posay Anthelios 60 Melt-In Sunscreen Milk, came away with a perfect score of 100 in 2018, making this the fourth year in a row that the product received a perfect score. The second place slot went to Equate’s Sport Lotion with a score of 99, and the only spray formula to receive a perfect score is a Trader Joe’s product.