The new formulation of benzoyl peroxide (BPO) may alter the way we treat our patients with rosacea. Find out how microencapsulation technology stabilizes BPO, improves outcomes for patients, and is changing our treatment armamentarium.
Rethinking the Use of Benzoyl Peroxide for Rosacea Treatment
RETHINKING THE USE OF BENZOYL PEROXIDE FOR ROSACEA TREATMENT
Rosacea is a common and chronic inflammatory dermatologic condition characterized by redness, flushing, visible blood vessels, and pustules. It may also cause acne-like breakouts and cause the skin to thicken and have a bumpy texture.1-3 Many clinicians do not understand the importance of diagnosing and treating rosacea early, but if left untreated, it can cause permanent redness.3 Due to the highly visible appearance of its effects, rosacea often causes embarrassment, anxiety, and depression and has a significant negative impact on quality of life and social functioning.1,2 It can be treated with topical agents, systemic medications, lasers, and light-based therapies.4 Benzoyl peroxide can be very helpful for patients with rosacea.5,6 Effective treatment can decrease severity, prevent scarring, and improve self-esteem and quality of life.7
RECOGNIZING ROSACEA AND PHENOTYPES
Rosacea is a highly visible chronic inflammatory cutaneous condition that affects up to 10% of the population. It is most common in women and usually affects fair-skinned women between the ages of 30 and 60.4,8 Rosacea typically presents on the forehead, nose, cheeks, and chin, but may also spread to the ears, chest, back, and even the eyes.1-3 The characteristic feature of rosacea is erythema that can be transient or persistent. Patients may also have telangiectasia, papulopustules, and swelling on the face. Flushing episodes due to acute or subacute intermittent vasodilation are also common. Unsightly redness and swelling of the nose and dilation of the pilosebaceous pores can also occur in chronic cases.4 Because of the “front and center” location on the face, rosacea adversely affects self-esteem, self-confidence, and mental health and limits social activities, having a major negative impact on quality of life.7,9
There are 4 subtypes of rosacea, which are not mutually exclusive2-4:
- Erythematotelangiectatic rosacea: characterized by redness, flushing, and visible blood vessels
- Papulopustular rosacea: characterized by redness, swelling, and an acne-like breakout
- Phymatous rosacea: characterized by thickened skin and a bumpy texture
- Ocular rosacea: characterized by red and irritated eyes, swollen eyelids, and pustules similar to styes
People with rosacea can have features of multiple subtypes, and the most predominant features and affected areas can change over time.2 The diagnostic features of rosacea phenotypes are shown here10:
OPTIMIZING ROSACEA TREATMENT
Despite its major impact, only a small fraction of the 16 million individuals living with rosacea seek treatment, leaving an estimated 82% untreated.11-13 This is due in large part to a lack of awareness of the availability of effective treatment options, which is an important educational gap. Without effective treatment, rosacea can have important psychosocial implications and long-term effects on overall health.13 Even when people with rosacea do seek treatment, the goal of clear skin is often not achieved because many clinicians do not understand the importance of diagnosing and treating rosacea early and effectively.8,14,15
It is important that clinicians are aware of the available treatment options for rosacea, including topical and systemic medications, lasers, and light-based therapies. Topical medications include azelaic acid, metronidazole, and sulfacetamide/sulfur; oral antibiotics include tetracyclines; and there are also topical and oral retinoids and benzoyl peroxide.4,6 One main reason that patients with rosacea fail to achieve their treatment goals is because clinicians do not routinely determine the patient’s phenotype.2 Recommendations from the American Acne and Rosacea Society encourage clinicians to evaluate the clinical manifestations that are present in each patient and to select treatments that address that phenotype.8 Recent recommendations also advise clinicians to determine the most important treatment targets for each patient and select treatment accordingly. Combination therapy may also be necessary. For example, skin barrier impairment can be treated with topical agents and certain systemic drugs; changes in innate immunity can be addressed with anti-inflammatory agents, antibiotics, and antioxidants; demodex can be targeted with antiparasitic drugs; and sebaceous glands can be targeted with isotretinoin and surgery.16
A NOVEL ENCAPSULATED FORMULATION OF BP CREAM ENHANCES EFFICACY AND TOLERABITLIY
A new microencapsulated formulation of benzoyl peroxide (BP) can change the treatment armamentarium for rosacea. In this formulation, BP is surrounded by a silica shell that serves as a barrier between the BP crystals and the skin, thereby reducing irritation. Skin lipids migrate through the silica shell and promote solubilization of the BP, which migrates through the sebaceous follicles in a controlled release fashion. This mechanism optimizes efficacy for rosacea and minimizes the potential for irritation.5,17 In a phase 2 randomized, double-blind, vehicle-controlled, dose-ranging study in 90 people with rosacea, 5% encapsulated BP was associated with higher rates of treatment success than 1% benzoyl peroxide cream.5 The efficacy and tolerability of the of microencapsulated benzoyl peroxide (E-BPO 5% cream) was studied in two identical phase 3 randomized, double-blind, vehicle-controlled trials in over 700 patients (n = 361 and n = 372) with moderate or severe papulopustular rosacea. They were randomized to E-BPO 5% cream or vehicle and applied the treatment once a day for 12 weeks. The primary efficacy endpoints were the proportion achieving Investigator’s Global Assessment (IGA) of clear/almost clear (0/1) and the absolute change in inflammatory lesion counts. As shown in the figure, a greater proportion of patients treated with E-BPO 5% cream in both trials achieved the of IGA 0/1 compared with the vehicle groups (43.5% versus 16.1% and 50.1% versus 25.9%, respectively). The absolute mean reduction in lesion counts from baseline were 17.4 versus 9.5 and 20.3 versus 13.3, respectively. The local tolerability (eg, dryness, scaling, itching, burning/stinging) of E-BPO 5% cream was similar to vehicle. The most frequently reported adverse events were mild to moderate application site erythema and pain.6,17
Efficacy and Safety of Benzoyl Peroxide Cream, 5%, Prepared with Microencapsulation in Papulopustular Rosacea: Results from Two Phase 3, Vehicle-Controlled Trials6
BP PLAYS AN IMPORTANT ROLE IN ROSACEA TREATMENT
To illustrate the place of BP in the rosacea treatment paradigm, consider the case of a 33-year-old Caucasian female who presents to her dermatologist with a 2- to 3-year history of central facial papules and pustules. She says that she is embarrassed about her appearance, and colleagues at work are starting to ask her about her condition. She emphasizes that the rash is having a significant negative impact on her quality of life and asks what she can do to clear the lesions. Based on the presence of flare, an anti-inflammatory dose of doxycycline is reasonable.18 Microencapsulated E-BPO 5% cream is also a good choice because it provides good efficacy and tolerability.6 This formulation and its production site are currently under review by the United States Food and Drug Administration.19 Overall, E-BPO 5% cream provides enhanced tolerability due to the controlled release of encapsulated BP and results in better treatment outcomes.20,21
- Zhao S, Wang M, Zhou Y, Yan Y. The therapeutic effects in patients with rosacea: how do we evaluate them? J Cosmet Dermatol. 2022;21(2):506-512.
- Farshchian M, Daveluy S. Rosacea. In: StatPearls [Internet]. StatPearls Publishing; 2022. https://www.ncbi.nlm.nih.gov/books/NBK557574/
- American Academy of Dermatology. What is rosacea? Accessed March 9, 2022. https://www.aad.org/public/diseases/rosacea/what-is
- Sharma A, Kroumpouzos G, Kassir M, et al. Rosacea management: a comprehensive review. J Cosmet Dermatol. Published online February 1, 2022. doi: 10.1111/jocd.14816
- Leyden JJ. Randomized, phase 2, dose-ranging study in the treatment of rosacea with encapsulated benzoyl peroxide gel. J Drugs Dermatol. 2014;13(6):685-688.
- Bhatia N, Werschler W, Baldwin H, et al. Efficacy and safety of micro-encapsulated benzoyl peroxide (E-BPO) cream, 5% in papulopustular rosacea: results from two phase 3, vehicle-controlled trials. Presented at: Maui Derm for Dermatologists 2020; Maui, Hawaii; January 25-29, 2020.
- 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 (Heidelb). 2019;9(4):725-734.
- Del Rosso JQ, Tanghetti E, Webster G, Stein Gold L, Thiboutot D, Gallo RL. Update on the management of rosacea from the American Acne & Rosacea Society (AARS). J Clin Aesthet Dermatol. 2019;12(6):17-24.
- Oussedik E, Bourcier M, Tan J. Psychosocial burden and other impacts of rosacea on patients' quality of life. Dermatol Clin. 2018;36(2):103-113.
- Tan J, Almeida LMC, Bewley A, et al. Updating the diagnosis, classification and assessment of rosacea: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017;176(2):431-438.
- Harper J, Del Rosso JQ, Ferrusi IL. Cross-sectional survey of the burden of illness of rosacea by erythema severity. J Drugs Dermatol. 2018;17(2):150-158.
- Wehausen B, Hill DE, Feldman SR. Most people with psoriasis or rosacea are not being treated: a large population study. Dermatol Online J. 2016;22(7):13030/qt4nc3p4q2.
- Koutnik-Fotopoulos E. Examining rosacea and comorbidities. The Dermatologist. April 2017. Accessed March 10, 2022. https://www.the-dermatologist.com/content/examining-rosacea-comorbidities
- Engin B, Özkoca D, Kutlubay Z, Serdaroğlu S. Conventional and novel treatment modalities in rosacea. Clin Cosmet Investig Dermatol. 2020;13:179-186.
- Juliandri J, Wang X, Liu Z, Zhang J, Xu Y, Yuan C. Global rosacea treatment guidelines and expert consensus points: the differences. J Cosmet Dermatol. 2019;18(4):960-965.
- Cribier B. Rosacea: treatment targets based on new physiopathology data. Ann Dermatol Venereol. 2021:S0151-9638(21)00098-3. doi:10.1016/j.annder.2021.11.001
- van Zuuren EJ, Arents BWM, van der Linden MMD, Vermeulen S, Fedorowicz Z, Tan J. Rosacea: new concepts in classification and treatment. Am J Clin Dermatol. 2021;22(4):457-465.
- Del Rosso JQ. Anti-inflamatory dose doxycycline in the treatment of rosacea. J Drugs Dermatol. 2009;8(7):664-668.
- Sol-Gel Technologies announces positive update related to FDA review status of EPSOLAY®. News Release. GlobeNewswire. December 21, 2021. Accessed March 10, 2022. https://www.globenewswire.com/en/news-release/2021/12/21/2355957/0/en/Sol-Gel-Technologies-Announces-Positive-Update-Related-to-FDA-Review-Status-of-EPSOLAY.html
- Petrou I. New drugs and therapies in 2022: acne, rosacea, and pruritis. Dermatology Times. January 24, 2022. Accessed March 13, 2022. https://www.dermatologytimes.com/view/new-drugs-and-therapies-2022-acne-rosacea-pruritus
- Rosen T, Bhatia N. New drugs and therapies in 2022. Presented at: 2022 Maui Derm for Dermatologists; Maui, Hawaii; January 24-28, 2022.
In accordance with the ACCME Standards for Integrity and Independence, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any ineligible company. GLC mitigates all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.
Neal Bhatia, MD
Therapeutics Clinical Research
San Diego, CA
Associate Clinical Professor, Harbor-UCLA Medical Center
Los Angeles, CA
Consulting Fees: Almirall, Biofrontera AG, Castle Biosciences, Dermavant Sciences, DermTech Inc., EPI Health, Ferndale Laboratories, Inc., Galderma Laboratories, L.P., ISDIN, La Roche-Posay Laboratorie Pharmaceutique, Mayne Pharma Group, Ortho Dermatologics, Sanofi/Regeneron, Sonoma Pharmaceuticals, Sun Pharmaceutical Industries Ltd., Vyome Therapeutics Limited
Contracted Research: AbbVie, Amgen, Arcutis, Inc., Atacama Therapeutics, Brickell Biotech, Inc., Bristol-Myers Squibb, Dermira, Dr. Reddy's Laboratories Ltd., DUSA Pharmaceuticals, Inc., Foamix, LEO Pharma, US, MC2 Therapeutics, Menlo Therapeutics, Pfizer Inc., Sanofi/Regeneron, Sol-Gel Technologies, Soligenix, Inc, Sun Pharmaceutical Industries Ltd., UCB, Vyome Therapeutics Limited
Jeffrey Sugarman, MD, PhD
Medical Director, Redwood Family Dermatology
Clinical Professor in Dermatology and Family Medicine
University of California, San Francisco
Santa Rosa, CA
Consulting Fees: Galderma, Pfizer, Regeneron, Sol Gel
- Stephen Chavez has nothing to disclose.
- Cindy Davidson has nothing to disclose.
- Amanda Hilferty has nothing to disclose.
- Libby Lurwick has nothing to disclose.
- Colleen Resnick has nothing to disclose.
After participating in this educational activity, participants should be better able to:
- Describe the efficacy and safety of benzoyl peroxide for the treatment of pustular rosacea
- Recognize the place of benzoyl peroxide in the treatment algorithm for pustular rosacea
- Describe the risks and benefits of the microencapsulated formulation of benzoyl peroxide for the treatment of rosacea
This activity is designed to meet the educational needs of dermatologists, dermatology mid-level providers, and other HCPs specializing in acne and rosacea.
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