New in My Practice: Rx

With Ted Lain, MD

In each issue, Practical Dermatology® magazine spotlights a new product that dermatologists are recommending to patients. Ted Lain, MD, a dermatologist and Chief Medical Officer at Sanova Dermatology in Austin, TX, discusses his experience with Almirall’s Klisyri (tirbanibulin), a field therapy for actinic keratosis that he’s been prescribing since its launch in February 2021.

What is Klisyri (tirbanibulin)?

Ted Lain, MD: Klisyri is a novel field therapy agent for actinic keratosis (AK). Its efficacy and tolerability were shown in a Phase 3 program including more than 700 patients, the largest trials ever performed for field therapy medications. While the exact mechanism of action for treating AK is unknown, Klisyri inhibits tubulin polymerization, thereby promoting apoptosis in proliferating cells, such as those present in AK.

What do the studies of Klisyri show?

Dr. Lain: The primary efficacy endpoint was full clearance of AKs at day 57. Patients had to have between four to eight typical actinic keratoses on a 25cm² area on either their face or scalp to qualify. In the pooled data from the two identical pivotal trials, 49 percent of patients in the active arm achieved full clearance vs only nine percent in the vehicle arm. I think dermatologists will also find the secondary efficacy endpoint applicable, which was 75 percent clearance of AKs at day 57, and this was achieved by 72 percent of patients in the tirbanibulin arm vs. 18 percent in the vehicle arm, again using pooled data.

Any patient selection pearls to share?

Dr. Lain: In the pivotal trials, more than 99 percent of subjects completed the five-day application of Klisyri, indicating how well it was tolerated. Tolerability is further supported by the peak composite local skin reaction (LSR) ratings. We found that the highest composite local skin reaction rating occurred at day eight, and quickly subsided by days 15-29. To put this into perspective, there were six metrics measured in the composite LSR, each one measured on a four-point scale (0-3). Therefore, the maximum available score is 18 for the composite rating. The mean peak score at day eight was around four for both trials, reducing to about two at day 15 and then at or below baseline by day 29. Given this excellent tolerability data, a pearl is that patient selectivity is really not required. Earlier Phase data showed no photosensitivity with tirbanibulin therefore I am not overly concerned about the seasonality when I prescribe this new agent.

How do you suggest patients use Klisyri?

Dr. Lain: Patients will receive a box containing five sachets of Klisyri ointment. Each sachet is meant for one nighttime application in a 25cm² area on either the face or scalp. The applications should be performed over five consecutive days. Patients should be instructed to avoid washing the area for eight hours after application, as well as to avoid transfer to the eye and periocular area.

How does Klisyri compare to other AK treatments?

Dr. Lain: There are no head-to-head studies, but in my experience the most striking difference between Klisyri and other field therapies is the tolerability. Whereas other field therapies often lead to marked erythema, swelling, and scaling, Klisyri seems to be a much gentler alternative. Indeed, I have had patients wonder if Klisyri was actually working based on the lack of LSRs! Whereas previously I spent time in patient encounters educating on the expected severity of the skin reactions when I prescribed our legacy field therapies, now, with Klisyri, I actually spend a bit of time telling patients what they likely will not experience.

BEAUTY COUNTER MD

Expert insight on the hottest products, ingredients, and trends your patients are talking about.
With Jeanine B. Downie, MD, FAAD

Slug It Out?

If you live with or know any Tik Tok-loving teens, you may have heard about “slugging” or sealing facial skin with an occlusive petrolatum-based agent overnight to boost hydration.

“This is not a trend that I am a fan of at all!” says Jeanine B. Downie, MD, FAAD, director of image Dermatology PC in Montclair, NJ. “A few of my younger patients have come in with significant breakouts after putting on Vaseline on their faces at night. It blocks pores and can make your acne much worse.”

Slugging may play a healing role on other parts of your body, she says. “You can put Vaseline on your hands and create an extra barrier of moisturizer for hydration,” she says. “Further, on your hands, it can help to heal cracks and dry patches.”

New Products

Emerage New Line, Emerage

Dr. Jason Emer’s newest product line is packed with scientific ingredients intended to produce results that are accessible to all. The Foaming Polish Cleanser, made of melted Jojoba beads and marine extract, cleanses and brightens skin and offers hydration. The Enzyme Polish is formulated with papaya and mixed acids to treat blemishes and acne. The Re-Fit Face & Eye Serums are ideal post-surgery. The daily face cream is powered by five cell-regenerating bio growth factors along with skin-nourishing amino acids, vitamins, and supercharged peptides to renew, revive, and restore skin tone and elasticity. The age-defying eye complex is also formulated with five cell-regenerating bio growth factors designed for the delicate, wrinkle-prone eye area. Nourishing amino acids, vitamins, and peptides deliver clinically-proven, anti-aging results, while maca root extract increases collagen to firm the skin, and titanium dioxide and silica conceal dark circles. AOX-C is a pure, super potent and stable Vitamin C 20% serum (Tetrahexyldecyl Ascorbate) that is packed with non-irritating, essential nutrients to reveal brighter, more even skin tone while protecting against environmental aggressors. HYLA-B is an intensive, plumping hydrator that offers a potent blend of hyaluronic acids in four different molecular weights to instantly improve skin texture and provide long-term hydration and improved elasticity. And Fusion Shield SPF 30 is a multifaceted chemical-free sunscreen is composed of Zinc Oxide, providing full mineral UVA/UVB coverage with 80 minutes of water resistance. Blended with antioxidants, including Vitamin C to fight environmental damage from free radicals. Emeragecosmetics.com

Pimple Paste, iNNBeauty Project

Many teens have heard the old wives’ tale that putting toothpaste on a pimple can help. As an alternative to toothpaste, which contains harsh ingredients and sulfates that can damage the skin, iNNBeauty Project created a skin-friendly paste that works quickly. Pimple Paste is an alcohol-free, fast-acting drying paste powered by natural ingredients. Formulated with natural miracle workers including: Willow Bark, Sulfur, Tea Tree Oil, Azelaic Acid, Clay, Zinc, Oregano, and Thyme that work overnight. This unique naturally blue paste dries down quickly and is transfer-proof so will not rub off on sheets or pillows. innbeautyproject.com

Redness Relief Cream, Gladskin

An international skincare brand with roots in Europe, Gladskin has launched of a new face cream for facial redness and rosacea-prone skin in the US. Gladskin is formulated to target the root of redness: the skin microbiome. Gladskin Redness Relief Cream features Gladskin’s patented endolysin technology, Micreobalance, which mimics nature’s natural defenses to safely restore bacterial balance to the skin microbiome, calm the skin, and improve resilience against common triggers. Micreobalance is a smart protein, an endolysin SA, that creates a healthy environment for good bacteria to thrive. Gladskin introduced the world’s first series of endolysin-based products for human health in Europe in 2015 and since that time, these products have helped people with inflammatory skin conditions such as eczema, inflammatory acne, and rosacea. Gladskin products are non-prescription; free of antibiotics, steroids, and preservatives; suitable for continual daily use. us.gladskin.com

Bio Gel Firm, Neocutis

Neocutis’ newest product, Bio Gel Firm, pairs the anti-aging and growth-factor formulation of Bio Gel with proprietary peptides to additionally support collagen and elastin production. The new super-hydrating Bio Gel Firm efficiently and effectively helps improve the appearance of aging skin. With a lightweight hydrogel formula, Bio Gel Firm delivers hydration with sodium hyaluronate while the combination of growth factors and proprietary peptides supports the production of many types of collagen, elastin, and hyaluronic acid necessary for healthy skin. Bio Gel Firm is formulated for all skin types, but this oil-free hydrogel formula is a great choice for those with oily or acne-prone skin and can soothe and refresh after cosmetic or dermatological treatments. It is also ideal for men, especially after shaving.

In a recent consumer perception study, 84 percent of Bio Gel Firm users noted that their skin looked firmer and healthier at day 90. Neocutis.com