Insights on Care for Skin of Color, Part 2

Neal Bhatia, MD, FAAD; Hilary Baldwin, MD; and James Q. Del Rosso, DO

Is it time to consider telemedicine at your dermatology practice?

Ekwa Marketing

Making Connections: Success in Your First Five Years

Neal Bhatia, MD, FAAD; Mark D. Kaufmann, MD, FAAD; Jonathan Weiss, MD; Kavita Mariwalla, MD; and Natasha Atanaskova Mesinkovska,MD, PhD

Insights on Care for Skin of Color, Part 1

Neal Bhatia, MD, FAAD; Hilary Baldwin, MD; and James Q. Del Rosso, DO

What Happens Next?

Experts offer suggestions to lead aesthetic medicine forward in the post- COVID-19 era.

Joel Schlessinger, MD, FAAD

On a recent episode of the video series “Coping with COVID-19” (co-produced by Practical Dermatology® magazine and Modern Aesthetics® magazine), Joel Schlessinger, MD; Joel L. Cohen, MD; Mark S. Nestor, MD, PhD; Doris Day, MD; Steve Dayan, MD; Michael Gold, MD; and Amy Forman Taub, MD put their heads together to ponder what cosmetic practices will look like after the COVID-19 crisis abates and aesthetic clinic doors are allowed to open.Panelists all agree that the social and economic impacts of the coronavirus pandemic are much different than those of the terrorist attacks of September 11, 2001 and the financial crisis of 2008, both of which also affected the practice of aesthetic medicine. Yes, rates of cosmetic surgeries fell during and after these events with some geographic locales being harder hit than others. By contrast, coronavirus is ubiquitous and invisible, and its effects on public health and economics are wide-ranging.Easing Waiting Room PhobiaIn the aftermath of September 11, people across the country wanted to come together and were largely able to do so. This is not the case with coronavirus, and it won’t be for a very long time, which has direct implications for how aesthetic doctors will see and treat patients. In the pre-COVID-19 days, aesthetic waiting rooms were packed with eager patients waiting for their injectables, peels, or laser skin resurfacing treatments, but calls for social distancing will leave many reticent about any type of gathering, even ones that takes place in a doctor’s waiting room replete with hand sanitizer.“After 9/11 people felt their mortality and wanted to look better,” shares Dr. Day, a New York City dermatologist. “They didn’t want to have surgery and take the bigger risk, but aesthetics grew. I worry that this will be different, because people will be afraid to go into a waiting room if other people are sitting in that waiting room.”GET MOREAesthetic Practice Status and Prognosis Watch as experts discuss what we know from historical precedent and medical science and assess what we still need to learn about COVID-19 and how it will affect the practice of aesthetic medicine.Watch Now: ModernAesthetics.com/COVID-19For these reasons, some physicians will take patient and staff temperatures with no-touch thermometers in addition to history and symptom screenings before appointments. If and when rapid antibody testing is available and reliable, these tests may assuage patient and staff fears and provide all comers with a sense of security.Optics will matter more and more in the post-COVID-19 world. Some doctors with suburban practices may consider letting patients check in from their cars and/or provide pagers to let patients know when the doctor is ready, predicts Dr. Schlessinger, an Omaha, NE-based dermatologist and the founder of Cosmetic Surgery Forum.Staggered appointment schedules can also help avoid crowds in the waiting room. Plexiglas or glass sneeze-guard shields for the front desk will be the new normal, and disposable branded masks with practice logos may well be the new give-away, replacing pens, water bottles, or ice packs.“We will have to rethink and consider how we market,” says Dr. Schlessinger. “There are so many facets in what we do and how we do it that will have to change in the post-COVID era [including] some sensitivity that we have to consider for our ads.” He noted that shaking hands is no longer considered appropriate and shouldn’t be included in any marketing stills. In addition, patients and physicians should be wearing face coverings in these materials when and where appropriate.Botox BoomWhen clinic doors first (re)open, there will be a backlog of medical dermatology patients who will need to be prioritized. There may be a run on neuromodulators and fillers as patients will be past due and others have likely spent weeks examining their lines and folds during Zoom or other video conferencing meetings. In addition, with unemployment rates rising, many patients will be looking for jobs and want to hit refresh on their appearance to compete with younger applicants. Here in lies an opportunity for new practices or med spas to break in at lower price points to capture these patients.“I won’t be surprised if we see med spas swell,” says Dr. Dayan, a facial plastic surgeon in Chicago. “Regulations are being reduced, and we may see med spas going crazy being able to inject and mobile spas showing up.”Dr. Gold adds that dermatologists and plastic surgeons will have to educate consumers about risks associated with seeking treatment from unqualified and inexperienced injectors. “We will need to let cosmetic patients know that we are open and here and willing to work with them to offer added-value services,” he says. “Yes, you could go anywhere you want, but we have 20, 30 and 40 years of experience.”First, do no harmThere are still many questions that need answers before cosmetic doctors can feel comfortable offering fillers and injectables to their patients in a post-COVID world. Even if a patient has no fever and antibodies that suggest he or she is no longer at risk, COVID-19 infection may represent a hypercoagulable state, and it is theoretically possible that soft tissue fillers could exacerbate vascularity in patients who are recovered but still somehow vulnerable, Dr. Day cautions.“We have to position ourselves as looking out for our patients’ best interests,” adds Dr. Taub, Founder of Advanced Dermatology and skinfo Specialty Skincare Boutique in Lincolnshire, IL. It’s important to discuss potential and theoretical complications, she added. “It’s better to be safe than sorry and protect people.”Procedures with less downtime and lower costs will likely also be quicker to make a comeback, says Dr. Cohen, Director of AboutSkinDermatology in Greenwood Village and Lone Tree, CO. Patients will not want to miss any more work than they already have due to shelter-in-place orders. “Patients will be less willing to do downtime procedures with the exception being people having a major event coming up,” he says. “Less expensive procedures that have cross-value, such as nonablative fractional lasers that make skin look better and will be doing something for skin cancer may be popular.”Work from home will likely become more commonplace even when restrictions are lifted, adds Dr. Nestor, Director of the Center for Cosmetic Enhancement and Director of the Center for Clinical and Cosmetic Research in Aventura, FL. “This may be an opportunity, as now patients can do laser resurfacing since they don’t have to be at work.”Paving the Way ForwardTeledermatology found its foothold during the pandemic and is likely here to stay. Cosmetic doctors will need to perfect the art of the online consultation, and medical dermatologists must develop protocols for assessing acne and atopic dermatitis and triaging skin cancer patients virtually. Still, these consults do have shortcomings and tend to lack that personal touch that sets many aesthetic physicians apart from their competition. In the future, care will likely be a hybrid model of teledermatology and in-office visits in the same patient.While challenges remain, panelists are optimistic on the whole that this too shall pass and that America will rebuild and when this happens, patients and physicians will feel more comfortable seeking and providing care and aesthetic treatments.

DermWireTV: AAD Virtual Data Highlights, Cynosure Consumer Data

What’s New in Topical Acne Treatment?

Neal Bhatia, MD, FAAD

It is sometimes easy to forget that in the not too distant past, successful acne treatment in the US relied heavily on oral antibiotics, acne was considered a disease with both “inflammatory” and “non-inflammatory” manifestations, and it was pigeon-holed as a disease of adolescence. Today, of course, dermatologists know that acne is at its root an inflammatory disease that, while it typically presents in adolescence, can persist through adulthood. We also have significantly reduced our dependence on oral antibiotics and implemented strategies intended to diminish the risk of contributing to antibiotic resistance.1Although our knowledge of acne developed at a rapid pace over the past decade or so, the therapeutic landscape remained relatively unchanged. That is quickly changing with a number of recent approvals and several new agents in development. Here’s a look at new and emerging treatments.SarecyclineThe approval of sarecycline (Seysara, Almirall) late in 2018 (it hit the market in early 2019) heralded a new era in acne drug approvals. Sarecycline is a novel tetracycline and was the first topical antibiotic approved for a dermatologic indication in more than 40 years. It has a narrower spectrum of activity compared to other tetracyclines and has reduced activity against enteric Gram-negative bacteria.2Among patients aged nine years or older with moderate to severe acne vulgaris who received sarecycline once daily for up to 40 weeks, there were low rates of TEAEs, with nasopharyngitis, upper-respiratory-tract infection, headache, and nausea being the only TEAEs reported by two percent or more of patients.3Data from Phase 3 clinical trials show that sarecycline provided significant reductions in both inflammatory and non-inflammatory lesions. At week 12, Investigator Global Assessment (IGA) success (≥2 point reduction in IGA and score Clear (0) or Almost Clear (1)) rates were 21.9 percent and 22.6 percent for active treatment, respectively, versus 10.5 percent and 15.3 percent, respectively, for controls.4Topical MinocyclineLast fall, the FDA approved Amzeeq (minocycline) topical foam 4%, from Foamix Pharmaceuticals for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. Formerly known as FMX101, it is the first topical minocycline to be approved by the FDA for any condition. Systemic minocycline has been the most commonly prescribed oral antibiotic for acne.5Topical minocycline foam 4% is associated with dramatic reduction of systemic minocycline exposure compared to oral administration, and there was no evidence of minocycline accumulation over 21 days of topical application.6In the 12-week Phase 3 randomized studies of minocycline foam 4%, active treatment was associated with a significantly greater reduction in both inflammatory and non-inflammatory active lesions, compared to foam vehicle.7,8 Subjects receiving active treatment had a greater rate of treatment success based on Investigator’s Global Assessment (P < .0001) versus the foam vehicle group at week 12.8A 1.5% minocycline foam formulation has shown benefit in trials for rosacea. In Phase 3 trials, active treatment was associated with statistically significant reductions in counts of inflammatory lesions of rosacea and significantly higher rates of IGA treatment success, compared to vehicle foam.9Still in development is a topical minocycline formulation developed by BioPharmX. BPX-01 uses a novel, patented HyantX delivery system, which stabilizes and solubilizes hydrophilic molecules in an anhydrous, biphasic gel. In a 12-week randomized, double-blind, vehicle-controlled, dose-ranging Phase 2b clinical trial, 25 percent of the intent-to-treat (ITT) population achieved a two-grade reduction to clear or almost clear. Interestingly, female patients had higher rates of success, relative to the overall ITT population.ClascoteroneNow under review at the FDA is clascoterone (Winlevi) 1% cream (Cassiopea). Clascoterone is a topically delivered androgen inhibitor that is thought to displace androgen hormones from the androgen receptors located at the sebaceous gland and hair follicle. Clascoterone acts locally on androgen receptors in the skin with no evidence of systemic exposure.In two Phase 3 trials recently published, topical clascoterone met it primary endpoints.10 Treated patients achieved statistically significantly greater rates of IGA Treatment Success (≥2 point reduction in IGA and score Clear (0) or Almost Clear (1)) at week 12, compared to controls. Treated subjects had treatment success rates of 16.1 percent and 18.7 percent, respectively, compared to 7 percent and 4.7 percent for vehicle, respectively. Active treatment subjects had reductions in non-inflammatory lesions of 30.7 percent and 29.3 percent, respectively, compared to 21.9 percent and 15.8 percent, respectively, for controls. Mean reductions from baseline in inflammatory lesions were 44.8 percent and 47 percent, respectively, for active treatment, compared to 36.6 percent and 29.8 percent, respectively, for controls.Rates of treatment-emergent adverse events (TEAE) were low and similar in the active and placebo groups in both studies.TrifaroteneThe first new topical retinoid approved for acne since the 1990s, trifarotene (Aklief Cream 0.005%, Galderma) selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. Of note, the clinical trials for trifarotene included assessments of facial (forehead, cheeks, nose, and chin) and truncal (chest, shoulders, and back) acne.In two randomized, multicenter, parallel group, double-blind, vehicle-controlled, 12-week Phase 3 clinical trials involving 2,420 patients, once-daily Aklief Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle (p<0.05).Tazarotene LotionArazlo (tazarotene, Ortho Dermatologics) Lotion, 0.045% has been approved for the topical treatment of acne vulgaris in patients nine years of age and older, the first tazarotene acne treatment available in a lotion form. In a head-to-head study, Arazlo demonstrated similar efficacy as tazarotene cream 0.1% with about half the adverse events yet with less than half of the percentage of active tazarotene. The most frequent adverse events reported with Arazlo (≥1%) were application site pain, dryness, exfoliation, erythema, and pruritus.In Phase 3 trials, tazarotene 0.045% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts at week 12. Mean percent reductions in inflammatory and noninflammatory lesions were 55.5 percent and 51.4 percent in Study 1 (versus vehicle: 45.7 percent and 41.5 percent, respectively) and 59.5 percent and 60 percent in Study 2 (versus vehicle: 49 percent and 41.6 percent, respectively) with tazarotene 0.1% cream at week 12. Treatment success was achieved by 25.5 percent (Study 1) and 29.6 percent (Study 2) of subjects treated with tazarotene 0.045% lotion.Among subject treated with tazarotene, improvements in quality-of-life domain scores were consistently greater with tazarotene.111. Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.2. Leyden JJ, Sniukiene V, Berk DR, Kaoukhov A. Efficacy and Safety of Sarecycline, a Novel, Once-Daily, Narrow Spectrum Antibiotic for the Treatment of Moderate to Severe Facial Acne Vulgaris: Results of a Phase 2, Dose-Ranging Study. J Drugs Dermatol. 2018 Mar 1;17(3):333-338.3. Pariser DM, Green LJ, Lain EL, Schmitz C, Chinigo AS, McNamee B, Berk DR. Safety and Tolerability of Sarecycline for the Treatment of Acne Vulgaris: Results from a Phase III, Multicenter, Open-Label Study and a Phase IPhototoxicity Study. J Clin Aesthet Dermatol. 2019 Nov;12(11):E53-E62.4. Moore A, Green LJ, Bruce S, Sadick N, Tschen E, Werschler P, Cook-Bolden FE, Dhawan SS, Forsha D, Gold MH, Guenthner S, Kempers SE, Kircik LH, Parish JL, Rendon MI, Rich P, Stein-Gold L, Tyring SK, Weiss RA, Nasir A, Schmitz C, Boodhoo TI, Kaoukhov A, Berk DR. Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. J Drugs Dermatol. 2018 Sep 1;17(9):987-996.5. . Lee YH, Liu G, Thiboutot DM, Leslie DL, Kirby JS. A retrospective analysis of the duration of oral antibiotic therapy for the treatment of acne among adolescents: Investigating practice gaps and potential cost-savings. Journal of the American Academy of Dermatology. 2014;71(1):70–76.6. Jones TM, Ellman H, deVries T. Pharmacokinetic Comparison of Once-Daily Topical Minocycline Foam 4% vs Oral Minocycline for Moderate-to-Severe Acne. J Drugs Dermatol. 2017 Oct 1;16(10):1022-1028.7.. Gold LS, Dhawan S, Weiss J, Draelos ZD, Ellman H, Stuart IA. A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies. J Am Acad Dermatol. 2019 Jan;80(1):168-177.8. Raoof TJ, Hooper D, Moore A, Zaiac M, Sullivan T, Kircik L, Lain E, Jankicevic J, Stuart I. Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: A phase 3 study. J Am Acad Dermatol. 2020 Apr;82(4):832-837.9.. Poster presented at the 2019 Winter Clinical Dermatology Conference, HI; January 18-23, 2019; Efficacy and Safety of FMX103 (1.5% Minocycline Foam) in the Treatment of Moderate-To-Severe Papulopustular Rosacea: Results from two Phase 3 Randomized, Multicenter, Double-Blind, Vehicle-Controlled Studies; Linda Stein Gold, MD, James Q. Del Rosso, DO, Neal D. Bhatia, MD, Deirdre Hooper, MD, Walter Nahm, MD, PhD, Iain Stuart, PhD.10. Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMADermatol. 2020 Apr 22.11. Tanghetti EA, Werschler WP, Lain T, Guenin E, Martin G, Pillai R. Tazarotene 0.045% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Results from Two Phase 3 Trials. J Drugs Dermatol. 2020 Jan 1;19(1):70-77.

Straight Scoop: Audience Questions Answered

Neal Bhatia, MD, FAAD; Kavita Mariwalla, MD; Mark D. Kaufmann, MD, FAAD; Natasha Atanaskova Mesinkovska,MD, PhD; and Jonathan Weiss, MD

DermWireTV: Dermatology Moves Beyond the COVID-19 Crisis