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An Updated Look at the Treatments for Rosacea

Worst Pills, Best Pills Newsletter article September, 2019

Rosacea is a common chronic skin condition that causes mild to severe redness or flushing on the cheeks, nose, chin or forehead and, over time, the appearance of visible blood vessels on the face.[1] It affects about 16 million Americans[2] and is most commonly found in adults starting at age 30 to 60; women, especially during menopause; individuals with fair skin; and those with a family history of rosacea.[3]

Although not generally disabling, this highly visible skin condition can...

Rosacea is a common chronic skin condition that causes mild to severe redness or flushing on the cheeks, nose, chin or forehead and, over time, the appearance of visible blood vessels on the face.[1] It affects about 16 million Americans[2] and is most commonly found in adults starting at age 30 to 60; women, especially during menopause; individuals with fair skin; and those with a family history of rosacea.[3]

Although not generally disabling, this highly visible skin condition can lead to serious social and emotional difficulties for some patients.[4]

There is no cure for rosacea, but there are treatments aimed at relieving symptoms. Only a handful of drugs are approved by the Food and Drug Administration (FDA) to treat rosacea, but doctors also prescribe many unapproved treatments to control this distressing condition.[5] Most rosacea drug treatments are not supported by strong evidence, and a few may even make the condition worse in the long term.

Signs and symptoms of rosacea

Rosacea symptoms tend to appear in cycles. During a flare-up of symptoms, blood vessels in the face swell, and the skin becomes irritated and inflamed. This causes redness, swelling, itching or burning sensations, and, in some patients, bumps and lesions that can be mistaken for acne.[6],[7]

In mild cases, the redness, bumps and lesions disappear between symptom flare-ups — sometimes without treatment.[8] However, over time, blood vessels under the skin may become permanently enlarged, resulting in redness that persists between flare-ups. In more severe cases, enlarged blood vessels appear as networks of tiny red lines just beneath the skin.[9],[10]

Eye symptoms are very common in people with rosacea.[11] Most cases of eye irritation due to rosacea involve mild dryness, burning or stinging.[12] However, in rarer cases, eyes may become severely inflamed, causing serious damage to the cornea, eventually leading to vision loss.[13]

In uncommon cases, rosacea can lead to the skin on the nose becoming thick, bumpy and swollen, making the nose appear enlarged.[14] Men are about 20 times more likely to experience this disfiguring symptom than are women.[15]

Nondrug prevention and treatment for rosacea flare-ups

The first step in treating rosacea is identifying triggers of symptoms and avoiding them to prevent flare-ups. Symptom flare-ups are often caused by a skin irritant, such as heat, cold, wind, skin care products, or even certain foods and drinks.[16] Additionally, emotional influences such as stress and anxiety also can trigger flare-ups.[17]

Proper skin care is also important. Skin should be washed daily using a gentle cleanser and kept free of irritating skin products. People with rosacea often develop dry, scaly skin due to loss of moisture.[18] Thus, a gentle moisturizer may help treat and prevent dryness.[19]

Topical drug treatments

Five topical treatments have been approved by the FDA for the treatment of rosacea: metronidazole cream, gel or lotion (METROCREAM, METROGEL, METROLOTION, NORITATE); azelaic acid gel (FINACEA); ivermectin cream (SOOLANTRA); brimonidine gel (MIRVASO); and oxymetazoline cream (RHOFADE).

Topical metronidazole and azelaic acid, both of which have antibacterial effects, were approved by the FDA in 1988 and 2002, respectively, to treat bumps and inflammatory lesions due to rosacea.[20],[21] Although it is unclear how these drugs work, both have been shown to be effective in reducing rosacea symptoms, with improvement occurring after three to six weeks of treatment.[22]

Ivermectin cream was approved in 2014 to treat the inflammatory lesions of rosacea.[23] Ivermectin, which in oral form is used to treat certain parasitic infections, was found in one clinical trial to provide slightly greater clinical benefits than the older topical metronidazole for reducing rosacea symptoms.[24] However, ivermectin was more likely to cause mild skin irritation, dryness and hypersensitivity than metronidazole. We have designated ivermectin cream as Do Not Use for Seven Years (until December 2021).

Brimonidine gel and oxymetazoline cream were approved by the FDA in 2013 and 2017, respectively, for treatment of persistent facial redness in patients with rosacea.[25],[26] These drugs work by constricting the blood vessels in the face. Their effects are only temporary, and redness begins to return just a few hours after application. These drugs also cause rosacea symptom flare-ups in some people, and facial redness may be worse after the medication wears off. Therefore, we have designated these topical drugs as Do Not Use.

Because rosacea is a chronic, recurring condition, doctors often recommend using these topical treatments for extended periods.[27] However, the safety and effectiveness of long-term treatment with these medications has not been established.

Oral antibiotics

For many years, doctors have prescribed oral antibiotics — most frequently tetracycline (ACHROMYCIN V), doxycycline (ACTICLATE, DORYX, MONODOX, ORACEA, VIBRAMYCIN) and minocycline (DYNACIN, MINOCIN, MINOLIRA, SOLODYN, XIMINO) — to treat severe or persistent rosacea symptoms.[28],[29]

In general, these antibiotics have been approved by the FDA for treatment of acne but not for treatment of rosacea. The one exception is ORACEA, a low-dose form of doxycycline (40 milligrams once daily) that is FDA-approved for reducing bumps and lesions due to rosacea (notably, it is not approved for treating any infections).[30] The drug likely works by decreasing inflammation, not by killing bacteria on the skin. Low-dose doxycycline is effective in decreasing rosacea lesions, and because of the low dosage, it is less likely to cause adverse effects, like diarrhea.[31],[32] However, there have not been high-quality clinical trials to show that low-dose doxycycline offers a substantial benefit over topical treatments in reducing rosacea symptoms.[33]

Importantly, overuse of antibiotics, even at low doses, may lead bacteria to adapt and become resistant to the drugs. Additionally, there is evidence from clinical trials suggesting that even low-dose doxycycline may disrupt the body’s natural intestinal bacteria, leading to diarrhea.[34] We therefore recommend that low-dose doxycycline be reserved for patients with severe rosacea that either has not responded to topical treatments or involves the eyes. The duration of oral treatment should be limited to the shortest period necessary to improve skin or eye lesions.

Alternative treatments and medications

Many other treatments have been used to treat rosacea, including certain other prescription drugs that are FDA-approved to treat acne, such as isotretinoin (ABSORICA, AMNESTEEM, CLARAVIS, MYORISAN, ZENATANE); over-the-counter treatments such as vitamin C skin products; laser therapy; and home remedies.

We recommend against using these treatments for rosacea, as they generally have not been studied in high-quality trials, so their safety and effectiveness remain unproven. Isotretinoin, which is not FDA-approved for treating rosacea, also causes dangerous adverse effects.[35]

What You Can Do

If you are diagnosed with rosacea, the goal of management should be to reduce the severity of any immediate symptoms and prevent future flare-ups.

If nondrug measures are not effective, ask your doctor to prescribe one of the FDA-approved topical antibacterial treatments (metronidazole or azelaic acid) to treat redness and bumps or lesions during symptom flare-ups. Do not use these drugs to prevent symptom flare-ups over a long period of time, as this could worsen symptoms and increase the risk of adverse effects. You should only use oral low-dose doxycycline if you have severe rosacea that has not responded to topical treatments or that involves the eyes.

Between flare-ups, prevent symptoms from returning by steering clear of symptom triggers. Keep your skin clean of potential irritants by washing your face carefully each day with a gentle cleanser. Wear protective clothing outdoors or apply a non-irritating sunblock, avoid cosmetics and harsh skincare products, and learn to recognize and avoid food and drinks that can trigger your symptoms.
 



References

[1] National Rosacea Society. All about rosacea. https://www.rosacea.org/patients/all-about-rosacea. Accessed July 9, 2019.

[2] National Rosacea Society. Rosacea now estimated to affect at least 16 million Americans. https://www.rosacea.org/rosacea-review/2010/winter/rosacea-now-estimated-to-affect-at-least-16-million-americans. Accessed July 9, 2019.

[3] American Academy of Dermatology. Skin conditions by numbers. https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed July 9, 2019.

[4] Moustafa F, Lewallen RS, Feldman SR. The psychological impact of rosacea and the influence of current management options. J Am Acad Dermatol. 2014;71(5):973-980.

[5] Powell FC. Rosacea. N Engl J Med. 2005;352(8):793-803.

[6] Del Rosso JQ. Management of cutaneous rosacea: Emphasis on new medical therapies. Expert Opin. Pharmacother. 2014;15(14):2029-2038.

[7] Powell FC. Rosacea. N Engl J Med. 2005;352(8):793-803.

[8] Del Rosso QD. Management of cutaneous rosacea: Emphasis on new medical therapies. Expert Opin. Pharmacother. 2014;15(14):2029-2038.

[9] Powell FC. Rosacea. N Engl J Med. 2005;352(8):793-803.

[10] National Rosacea Society. All about rosacea. https://www.rosacea.org/patients/all-about-rosacea. Accessed July 9, 2019.

[11] Powell FC. Rosacea. N Engl J Med. 2005;352(8):793-803.

[12] Ibid.

[13] Ibid.

[14] National Rosacea Society. All about rosacea. https://www.rosacea.org/patients/all-about-rosacea. Accessed July 7, 2019.

[15] Powell FC. Rosacea. N Engl J Med. 2005;352(8):793-803.

[16] Ibid.

[17] National Rosacea Society. Factors that may trigger rosacea flare-ups. https://www.rosacea.org/patients/rosacea-triggers/factors-that-may-trigger-rosacea-flare-ups. Accessed July 9, 2019.

[18] Del Rosso JQ. Management of cutaneous rosacea: Emphasis on new medical therapies. Expert Opin. Pharmacother. 2014;15(14):2029-2038.

[19] Buddenkotte J, Steinhoff M. Recent advances in understanding and managing rosacea. F1000Res. December 3, 2018. pii: F1000 Faculty Rev-1885. doi: 10.12688/f1000research.16537.1.

[20] Galderma Laboratories. Label: metronidazole gel (METROGEL). June 2019. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ab3a8a2d-714a-4beb-af8a-99bc3ac3ebbe&type=display. Accessed July 9, 2019.

[21] Leo Pharma, Inc. Label: azelaic acid gel (FINACEA). August 2018. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=bea1957c-55ca-48cd-8cbc-ed44d546a857&type=display. Accessed July 9, 2019.

[22] van Zuuren EJ, Fedorowicz Z, Carter B, et al. Interventions for rosacea. Cochrane Database Syst Rev. 2015 April 28;(4):CD003262.

[23] Galderma Laboratories. Label: ivermectin cream (SOOLANTRA). May 2018. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b1d5b166-ab06-4ab5-b0c6-31126238118a&type=display. Accessed July 10, 2019.

[24] van Zuuren EJ, Fedorowicz Z, Carter B, et al. Interventions for rosacea. Cochrane Database Syst Rev. 2015 April 28;(4):CD003262.

[25] Galderma Laboratories. Label: bromonidine tartrate gel (MIRVASO). June 2018. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f6a4353f-ae69-4214-901f-e5d42a6fbde7&type=display. Accessed July 10, 2019.

[26] Aclaris Therapeutics. Label: oxymetazoline hydrochloride) cream (RHOFADE). November 2019. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8968299e-2a4f-41a8-9088-6343ea6c91f4&type=display. Accessed July 10, 2019.

[27] van Zuuren EJ. Rosacea. N Engl J Med. 2017;377(18):1754-1764.

[28] Powell FC. Rosacea. N Engl J Med. 2005;352(8):793-803.

[29] van Zuuren EJ. Rosacea. N Engl J Med. 2017;377(18):1754-1764.

[30] Galderma Laboratories. Label: doxycycline (ORACEA). August 2017. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=aa15c93a-ff4c-447a-8a21-96da506d8997&type=display. Accessed July 10, 2019.

[31] Del Rosso JQ, Webster GF, Jackson M, et al. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol 2007;(56):791-802.

[32] van Zuuren EJ, Fedorowicz Z, Carter B, et al. Interventions for rosacea. Cochrane Database Syst Rev. 2015 April 28;(4):CD003262.

[33] Ibid.

[34] Food and Drug Administration. Medical Review: NDA 50-805. May 26, 2006. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050805s000_MedR.pdf. Accessed July 11, 2019.

[35] Amneal Pharmaceuticals. Label: isotretinoin. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c2917c3d-3499-48a0-ba53-120cb979195d&type=display. Accessed July 10, 2019.