. At least they should be, according to Julie C. Harper, MD.
“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.
“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”
Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.
S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”
T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.
O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.
“The P stands for: Develop a plan that addresses all of that,” she said.
Different treatments for different rosacea symptoms
No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.
“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”
Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.
Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
Anti-inflammatory action for pustules and papules
A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.
“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”
In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.
At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.
Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”
Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”
Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.
“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”
The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).
At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.
Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”
Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.
By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.
“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”
Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.
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