Approximately 5-46% of the global adult population suffers from rosacea, whereas children are less commonly affected.
Rosacea is a chronic inflammatory skin disorder with a variety of clinical presentations, which may include erythema, inflammatory lesions (papules or pustules), telangiectasia, and edema. Often, these symptoms are accompanied by flushing, dryness, burning sensations, or pain. Given its significant adverse impact on an individual’s quality of life and psychological well-being, developing therapies to address the heterogeneous nature of this disease is a growing field of research. Currently the most commonly recommended rosacea treatments include proactive skin care, oral medications, and topical therapies.
Rosacea is best controlled with a multi-faceted treatment strategy that incorporates skin care, patient education, and proper medication choices.
Physicians recommend moderation with skin care, as there is clinical evidence of a correlative relationship between rosacea incidence and excessive use of cleansers, moisturizers, or sunscreens. By taking a well-informed and gentle skin care approach, patients can proactively avoid irritating triggers, while fortifying their already compromised epidermal barrier.
Managing moderate-to-severe rosacea may require systemic intervention.
First-line FDA-approved topical therapies for rosacea include metronidazole, sulfacetamide/sulfur, and azelaic acid.
Metronidazole, a nitroimidazole-derivative, was the first FDA-approved topical for treating rosacea. This well-tolerated agent combats inflammatory lesions, as well as perilesional and background erythema by modulating neutrophilic activity.
The combined antibacterial, keratolytic, and anti-inflammatory properties of sulfacetamide/sulfur can improve inflammatory lesions, as well as perilesional and background erythema in papulopustular rosacea.
Azelaic acid’s anti-inflammatory and antioxidant properties treat mild-to-moderate rosacea by reducing inflammatory lesion count and improving patients’ mean erythema scores. It was approved by the FDA in 2002.
Newer FDA-approved topical treatments for rosacea include brimonidine, ivermectin, oxymetazoline, and minocycline.
Brimonidine, an α2-adrenergic receptor agonist, was approved in 2013 for treating persistent erythema associated with rosacea. Through vasoconstriction and reduction of inflammatory cell infiltration, brimonidine demonstrated significant improvement of erythema in phase III clinical trials. Its side effects may include flushing, burning, irritation, or pruritus at the site of application.
Topical ivermectin, an avermectin derivative, was approved in 2014 for treating rosacea based on its acaricide and anti-inflammatory properties. Compared with other topicals, ivermectin 1% cream has demonstrated favourable tolerability, efficacy, and safety profiles.
Oxymetazoline, an α1-adrenergic receptor agonist, was approved in 2017 for treating moderate-to-severe facial erythema in rosacea via vasoconstriction and anti-inflammatory actions. Based on phase III and IV clinical trials, this topical posed minimal safety risks, as well as demonstrated significant improvements in Clinical Erythema Assessment and Patient’s Self-Assessment scores from baseline to Week 52.
Topical minocycline, a second-generation tetracycline agent, was approved by the FDA in 2020 for treating papulopustular rosacea. The safety and efficacy of minocycline was confirmed by two pivotal phase III randomized clinical trials conducted in a total of approximately 1533 patients.
On April 25, 2022, EPSOLAY®, a collaboration between Sol-Gel Technologies and Galderma, became the newest FDA-approved treatment for mild-to-moderate rosacea.
EPSOLAY® contains a proprietary encapsulated cream formulation of benzoyl peroxide 5%. Its silica-based shell ensures the medication is released slowly over time, which contributes to its favourable safety and efficacy profile for sensitive skin affected by rosacea.
Sol-Gel Technologies was granted patents covering their proprietary formulation of EPSOLAY® which will remain in effect until 2040. Galderma has received an exclusive license to commercialize EPSOLAY® in the U.S.
In two double-blinded phase III randomized clinical trials with approximately 733 participants, the EPSOLAY® treatment group experienced a nearly 70% reduction in their inflammatory lesions over 12 weeks of use. In comparison, the placebo group only experienced a reduction of 38-46% during this time. In the open-label extension study, 73% of 547 participants demonstrated Investigator’s Global Assessment scores of 0 (clear) or 1 (almost clear) after 52 weeks of use.
The most common adverse events associated with EPSOLAY® include pain (2%), erythema (2%), pruritus (1%), and edema (1%) at the site of application. The medication label also includes a warning label containing potential hypersensitivity reactions to benzoyl peroxide, skin irritation, contact dermatitis, and photosensitivity. Consult with your doctor to determine whether EPSOLAY® may be right for your rosacea.
Rosacea is a heterogeneous skin disorder with a significant disease burden that necessitates variety in the range of available treatments.
Taking a phenotype approach, wherein the unique clinical presentation and concerns of the individual patient are closely considered, may be ideal when selecting rosacea medications. Multiple therapies, traditional and newly approved, are currently available for this indication and many more are in the developmental pipeline for the future. If you have been diagnosed with rosacea, discuss with your physician to develop a treatment regimen that is best tailored to your symptoms.