PracticalDermatology

As physicians who typically deal with clearly visible diseases of the skin, hair, and nails, dermatologists are often able to quickly assess a disorder and prescribe the appropriate protocol. However, rosacea presents a unique challenge. A disorder of complex manifestations, rosacea was recently redefined as a single disease with multiple potential phenotypes that may occur in many possible combinations, and each of these should be targeted individually.¹ In spite of its complexities, clear skin is possible, but to achieve the best results, therapies must be monitored and possibly adjusted. The key is an ongoing partnership with patients, but the dermatologist’s biggest challenge may be getting their patients to pay attention.

Patients with rosacea are motivated to participate in their treatment. Symptoms including redness, papules, pustules, and possibly rhinophyma are conspicuous and embarrassing and contribute to negative emotional, social, and professional outcomes. Persistent erythema, one of the two diagnostic features of rosacea, is especially troubling, with some sufferers even reporting Dermatology Quality of Life Index scores comparable to those of patients with eczema, atopic dermatitis, and psoriasis.²

But rosacea patients, especially those accustomed to addressing the groupings of signs and symptoms previously identified as subtypes with a single therapy, may not understand that although rosacea has no cure, reaching clear or almost clear is possible with open and continuous cooperation between patient and physician and compliance with therapy. They may be impatient with the pace of improvement or may fall into old habits with regard to adherence. And they may not express dissatisfaction with their treatment regimen to their physician.

Dermatologists must take the lead. Each rosacea case is individual, and physicians can establish a working framework that changes the patient’s self-perception from that of a subordinate carrying out a burdensome chore to a partner in a mutual quest for the prize of clear skin. Practitioners may begin to encourage the patient’s compliance by simply upgrading his or her expectations: stating that clear skin is the achievable goal, but multiple visits using multiple tools will be required, as well as feedback from the patient. The initial visit will be an investment in this goal: it may be lengthy and include identifying visible signs and symptoms and determining what bothers the patient, as well as taking a rosacea history to identify features that may appear intermittently but are not currently visible. This visit will also include education about effective skincare and sun protection, as well as trigger factors and a comprehensive initial treatment plan including therapies for all phenotypes present.

New Treatments Emerge for Rosacea, Acne

Epsolay Launches in the US for Rosacea. Epsolay, a proprietary cream formulation of benzoyl peroxide, 5%, is now available for the treatment of inflammatory lesions of rosacea in adults. Galderma is launching Epsolay in the US, following FDA approval in April. The drug was developed by Sol-Gel Technologies.

The benzoyl peroxide in Epsolay is encapsulated within silica-based patented microcapsules. The silica-based shell is designed to slowly release benzoyl peroxide over time. Approval was supported by data from two identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of Epsolay compared to vehicle in people with inflammatory lesions of rosacea (N = 733). The coprimary endpoints in both trials were the proportion of subjects with treatment success and the absolute change from baseline in lesion counts at Week 12. Epsolay was more effective than vehicle cream on these endpoints starting from 4 weeks of treatment. With Epsolay treatment, inflammatory lesions of rosacea were reduced by nearly 70% by the end of both trials vs. 38-46% with vehicle. Nearly 50% of subjects were “clear” (IGA=0) or “almost clear” (IGA=1) at 12 weeks vs. 38-46% with placebo. In the open-label extension, 73% of treated subjects were “clear” (IGA=0) or “almost clear” (IGA=1) at 52 weeks (N = 547).

Galderma Launches Twyneo in the US. Galderma has launched Twyneo Cream in the US. It is the first 0.1% tretinoin and 3% benzoyl peroxide (BPO) 2-in-1 combination to treat moderate to severe facial acne.

In clinical trials, some subjects saw results in as little as two weeks of using Twyneo Cream, and their skin continued to clear over time. These studies demonstrated a 25 percent decrease in pimples at two weeks and a 58–66 percent decrease at 12 weeks. In all, 27–41 percent of people achieved clear or almost clear skin by the end of the trial. More than half of people who used Twyneo Cream were satisfied at two weeks, and by 12 weeks of treatment, 8 in 10 subjects were satisfied with their results.

Twyneo Cream segregates and envelopes the active ingredients in silica core shells that keep both crystals separate and stable while gradually releasing onto the skin, offering a treatment that is very effective and very tolerable, says Hillary Baldwin, MD, principal investigator for the Twyneo Cream clinical trials.

Dr. Baldwin says this product could lead to improved compliance with treatment, particularly with teenaged boys, the patient group most unlikely to comply. Twyneo is easy to use—it basically offers two prescriptions in one product. It’s applied once a day and can be applied whenever is most convenient for patients.

“When you’re dealing with teenagers, especially, the fewer rules you give, the better. Part of it is psychological. The psychologist will tell you that giving teenagers control over anything in their lives, since they have control over nothing, is helpful,” Dr. Baldwin says. “You seem like the good guy, if you say, ‘You know what? I want you to put this on anytime you feel like you want to put it on you.’ You give them control and that’s helpful.” She recommends reminding patients that benzoyl peroxide can bleach fabric and that it’s important to use sunscreen.

Set the stage for full disclosure on the part of the patient by being specific and detailed in educating him or her on compliance with therapy. Patients who have struggled with rosacea for many years may feel overwhelmed with the necessity of multiple medications. Make sure to explain why each medication is necessary and how each should be used, including frequency and areas of application as well as time of day—a patient who applies an alpha agonist before going to bed won’t see the full benefit of treatment, for example.

Then mandate the patient’s role, which includes keeping a diary noting their exposure to anything on a list of dietary, lifestyle, and environmental factors that may trigger a rosacea flare-up to establish the defining elements of their own particular case. A comprehensive list of potential trigger factors as well as a printable diary booklet are available from the National Rosacea Society website at rosacea.org.

This type of written (or digital) record-keeping is invaluable in developing a specific therapy regimen that is sensitive to the needs of the individual patient. The booklet includes a line to indicate compliance with medical therapy; advises patients to make additional full-disclosure notes, being specific as well as honest about noncompliance, recording days that were missed and any change to the method and areas of application. Patients should also include any and all questions that may arise as part of their daily documentation.

The attitude of the dermatologist is key. Patients may often feel guilt when they miss a dose but treating a missed dose as a vital clue rather than a sin will promote the kind of feedback necessary for the best outcome. Moreover, let patients know that faithful compliance can yield benefits that were formerly unsuspected; some medications work synergistically to achieve better results when used together than when used separatelymand may even inhibit the progress of the disorder.

Therapy for rosacea is no longer a blunt instrument but a sophisticated tool. Fully assimilated, the mechanics of improving rosacea’s appearance and maintaining remission can be like brushing teeth—a standard daily health habit.

1. Gallo RL, Granstein RD, Kang S, et al. Standard classification and pathophysiology of rosacea: The 2017 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol 2018 Jan;78(1):148-155. doi: 10.1016/j.jaad.2017.08.037. Epub 2017 Oct 28.

2. Baldwin HE, Harper J, Baradaran S, Patel V. Erythema of rosacea affects health-related quality of life: results of a survey conducted in collaboration with the National Rosacea Society. Dermatol Ther 2019;9(4):725–734. doi:10.1007/s13555-019-00322-5