(BPT) - Anyone who deals with the redness, bumps and inflammationi,ii of rosacea, may understand the frustrations that come with this common skin disorder.ii,iii As with many diseases, doctors and researchers still don’t know the exact cause of the inflammation and how it affects the skin on a person’s face.i However, thanks to some recent research, Galderma Laboratories, L.P. is a step closer to understanding how one proven treatment works.
Facts about Rosacea
Rosacea is a chronic, inflammatory skin condition affecting the face.i,ii While the exact cause of rosacea is unknown, it affects an estimated 16 million Americans (about one in 20) and 40 million people worldwide, according to the National Rosacea Society (NRS).i,iii,iv With varied symptoms, it can be challenging for sufferers to manage.i Additionally, statistics show that rosacea is more common in women, but symptoms tend to be more severe in men.i According to a NRS survey of more than 2,000 patients, both men and women experienced rosacea symptoms on their chin, cheeks and forehead.v Symptoms of rosacea may include:
- Redness or a flushed appearance on the skin of the facei
- Persistent rednessi
- Bumps that may contain pus or be solidi
- Visible blood vesselsi
- A stinging or burning sensationi
- Irritation of the eyesi
- Facial swellingi
- Thickening of the skin, most commonly seen on the nosei
To help manage rosacea, a proper skin-care regimen and an appropriate treatment plan can be used.i
While there is no cure for rosacea, it can be treated and managed effectively.i The NRS notes that treatments may include various oral and topical medications to treat the bumps and blemishes often associated with rosacea, and a topical therapy to reduce facial redness.i Additionally, treatments may also include lasers, intense pulsed light sources or other medical and surgical devices to remove visible blood vessels or reduce extensive redness.i
An oral treatment option available to patients marketed by Galderma Laboratories, L.P. is Oracea® (doxycycline, USP) 40 mg* Capsules (OR-RAY-SHA), the only FDA-approved once-daily, oral therapy for the treatment of the bumps and blemishes of rosacea.vi Oracea Capsules are unique because they treat rosacea from the inside out.vi They are an oral medication that treats inflammation below the skin to reduce the bumps and blemishes developing on the surface.vi The active ingredient in Oracea Capsules is doxycycline, but unlike traditional antibiotic doses of doxycycline, this precise formulation does not work as an antibiotic.vi Instead, it works by reducing the bumps and blemishes of rosacea because of its anti-inflammatory properties,i,vi which is important because rosacea is a chronic inflammatory skin condition, not a bacterial infection.i,ii This is incredibly important to consumers, as Oracea Capsules had no evidence of bacterial resistance in a nine-month study.vii
It is important for people who think they have rosacea to talk to a dermatologist about their symptoms because without proper medical treatment, rosacea can worsen over time and may become more difficult to treat.i
Biomarkers in Rosacea
A biomarker is a biological substance whose level in the human body can be indicative of a particular disease or condition.viii In patients living with rosacea, cathelicidins and serine proteases are thought to be biomarkers involved in the disease.ix Proteases are enzymes that break down proteins into peptides, and cathelicidins are a type of peptide.x
Recent research sponsored by Galderma Laboratories, L.P. looked to verify the role of cathelicidins and protease activity as biomarkers in rosacea.viii The study found that when cathelicidin levels were brought down to normal levels, the inflammatory bumps and blemishes of rosacea were also reduced.viii While it has been known since 2006, when the FDA approved Oracea Capsules, that they are effective at reducing these inflammatory bumps, this recent research also shows the association between treatment with Oracea Capsules and reduction in cathelicidin and protease activity in rosacea patients.viii Additionally, the study also demonstrated that low levels of protease activity and high levels of cathelicidins at baseline predicted treatment success, and Oracea Capsules reduced levels of these biomarkers.viii In the study, 26 patients (31.0%) in the doxycycline group and 16 patients (18.6%) in the placebo group reported adverse events (AEs).viii These AE’s were mostly mild in severity and unrelated to the study drug.viii AEs occurring in more than two patients were nausea and sinusitis in the doxycycline group, and upper respiratory infection in the placebo group.viii
“In the study population, Oracea Capsules reduced the inflammatory biomarkers associated with rosacea,” said Dr. Philip Brown, MD, JD, Senior Vice President, Medical and Regulatory Affairs, Galderma Laboratories, L.P. “Those with the best treatment outcomes showed a greater reduction in the associated biomarkers. This information could help us continue to develop even more effective treatments for meaningful, lasting relief of the symptoms associated with this common skin condition.”
For more information about Oracea® Capsules, see Full Prescribing Information available on www.Oracea.com.
Important Safety Information – Oracea® Capsules
Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, ORACEA Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established.
*30 mg immediate release & 10 mg delayed release beads
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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i National Rosacea Society. All About Rosacea. https://www.rosacea.org/patients/allaboutrosacea.php. Accessed on October 6, 2016.
ii Blount BW et al. Rosacea: A Common, Yet Commonly Overlooked, Condition. Am Fam Physician. 2002;66: 435-440.
iii National Rosacea Society. 50 Shades of Red: Rosacea Takes Emotional Toll. https://www.rosacea.org/weblog/50-shades-red-rosacea-takes-emotional-toll. Accessed on October 6, 2016.
iv Galderma. Face Values: Global Perceptions Survey Report. http://www.galderma.com/Portals/0/2014%2009%2025_Face%20Values%20Global%20Perceptions%20Survey_LOW_RES.pdf. Accessed on October 6, 2016.
v National Rosacea Society. Men with Rosacea Face Different Symptoms. https://www.rosacea.org/weblog/men-rosacea-face-different-symptoms. Accessed on October 6, 2016.
vi ORACEA [Prescribing Information]. Galderma Laboratories, L.P.; Fort Worth, TX; 2006
vii Data on File, Galderma Laboratories, L.P.; Webster. Topical and Systemic Treatments in the Management of Rosacea. April 6, 2010.
viii Nardo AD et al. Improved clinical outcome and biomarkers in adults with papulopustular rosacea treated with doxycycline modified-release capsules in a randomized trial. J Am Acad Dermatol. 2016;74(6):1086-92.
ix Strimbu K et al. What are Biomarkers? Curr Opin HIV AIDS. 2010;5(6): 463-466.
x Neitzel J et al. Enzyme Catalysis: The Serine Proteases. Nature Educ. 2010;3(9): 21.