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Perioral dermatitis. Clin Dermatol. 2011 Mar-Apr;29(2):157-61 Authors: Lipozencic J, Ljubojevic S Perioral dermatitis is a relatively common inflammatory disorder of facial skin, often appearing in patients with rosacea, but with less inflammation. A typical perioral dermatitis presentation occurs with the eruption of papules and pustules confined to the nasolabial folds and the skin of the chin. Clinically, small pink papules and pustules may recur over weeks to months, sometimes with fine scales. The differential diagnosis includes seborrheic dermatitis, systemic lupus erythematosus, acne vulgaris, lupus miliaris disseminatus faciei, steroid-induced rosacea, and even basal cell carcinoma. The histopathology is similar to that found in rosacea. With advancement of the process, a perivascular and perifollicular lymphohistiocytic infiltrate develops. Sebaceous hyperplasia may be prominent in some patients. The most severe forms of disease show perifollicular noncaseating epithelioid granulomas. Treatment may include topical metronidazole as for rosacea (once or twice daily), azelaic acid cream, benzyl peroxide preparations, and to a lesser degree, topical erythromycin, clindamycin, or tetracycline. Oral tetracycline, doxycycline, or minocycline may also be helpful in presentations that are more resistant. PMID: 21396555 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21396555&dopt=Abstract = URL to article

The coordinated response of the physical and antimicrobial peptide barriers of the skin. J Invest Dermatol. 2011 Feb;131(2):285-7 Authors: Borkowski AW, Gallo RL Antimicrobial peptides (AMPs) are an essential and multifunctional element for immune defense of the skin during infection and injury. In this issue, Ahrens et al. characterize the response of β-defensins, a class of AMPs, following acute and chronic challenges to the permeability barrier of the skin. Their findings suggest that the antimicrobial and permeability barriers of the skin are closely linked. PMID: 21228809 [PubMed - indexed for MEDLINE] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21228809&dopt=Abstract = URL to article

Granulomatous rosacea: Unusual presentation as solitary plaque. Dermatol Online J. 2011;17(2):9 Authors: Batra M, Bansal C, Tulsyan S A 45-year-old male presented with a 6 month history of an enlarging smooth, erythematous plaque over the central part of his face. Mild erythema of both eyes was present. Sarcoidosis, Hansen disease, lupus vulgaris, cutaneous leishmaniasis, pseudolymphoma, foreign body granuloma, granuloma faciale, discoid lupus erythematosus, and granulomatous rosacea were considered in the differential diagnosis. CBC, urinalysis, renal function tests, liver function tests, serum electrolytes, and blood sugar were all normal. Chest X-ray and ECG revealed no abnormality. Serology for syphilis and HIV, and mantoux test were negative. Slit-skin smear, tissue smear and culture for AFB and fungi were negative. Skin biopsy revealed multiple non-caseating epitheloid granulomas around the pilosebaceous unit suggestive of granulomatous rosacea. Granulomatous rosacea, a rare entity comprising only about 10 percent of cases of rosacea can mimic many granulomatous conditions both clinically and histologically making the diagnosis an enigma. It usually presents as yellowish brown-red discrete papules on the face; non-caseating epithelioid granulomas are seen on histology examination. We herein report the case because it presented in atypical fashion, as a solitary indurated plaque on the nose, likely representing Morbihan's disease or solid persistent facial edema of rosacea (rosacea lymphedema). PMID: 21382292 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21382292&dopt=Abstract = URL to article

Rosacea fulminans in pregnancy with ocular perforation. J Dtsch Dermatol Ges. 2011 Mar 2; Authors: de Morais E Silva FA, Bonassi M, Steiner D, da Cunha TV PMID: 21366860 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21366860&dopt=Abstract = URL to article

Clinical and laboratory study of ocular rosacea in northern Greece. J Eur Acad Dermatol Venereol. 2011 Mar 2; Authors: Lazaridou E, Fotiadou C, Ziakas N, Giannopoulou C, Apalla Z, Ioannides D Background  The prevalence of ophthalmic involvement in rosacea is probably higher than previously presumed and varies considerably among several studies. Objective  This study aimed to determine the incidence of ocular disease among a population of rosacea patients in Northern Greece, to objectively determine the presence of eye dryness in rosacea patients with and without clinical ophthalmic involvement and correlate the severity of ocular disease with the severity of cutaneous rosacea. Methods  One hundred patients with rosacea were assessed for the stage of their disease and examined for ocular symptoms and signs. In 24 of them the tear break up time (TBUT) and Schirmer test were performed in each eye, along with 24 controls. Results  A total of 33 patients (33%) were positive for ophthalmic findings. The most frequent symptoms and signs were burning sensation and tearing, and conjunctivitis and blepharitis, respectively. Eleven patients with ophthalmic manifestations had mild to moderate erythematotelangiectatic rosacea, 17 had moderate papulopustular rosacea and four exhibited findings of phymatous rosacea. The total mean value of patients' Schirmer tests was significantly lower compared with the healthy controls (P < 0.0001). Mean TBUT was shorter in the rosacea group than that in the age-matched controls (P < 0.0001). Conclusion  Ocular involvement in rosacea is a common phenomenon with eye dryness being an early sign. Tear function tests, like Schirmer test and TBUT, although not specific, could contribute to the screening and early diagnosis of the disease, to prevent the potential development of sight-threatening conditions. PMID: 21366706 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21366706&dopt=Abstract = URL to article

Rosacea (erythematotelangiectatic type) effectively improved by topical xylometazoline. J Dermatol. 2010 Nov 3; Authors: Kim JH, Oh YS, Ji JH, Bak H, Ahn SK PMID: 21352348 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21352348&dopt=Abstract = URL to article

Frequency, phenotype, outcome, and therapeutic impact of skin reactions following initiation of adalimumab therapy: Experience from a consecutive cohort of inflammatory bowel disease patients. Inflamm Bowel Dis. 2011 Feb 23; Authors: Baumgart DC, Grittner U, Steingräber A, Azzaro M, Philipp S BACKGROUND: The monoclonal anti tumor necrosis factor (TNF) antibody adalimumab has recently been approved for Crohn's disease (CD) and evaluated for ulcerative colitis (UC). Cutaneous lesions associated with its administration have not been prospectively studied in inflammatory bowel disease (IBD). METHODS: We evaluated the first 50 consecutive patients (female n = 30, median age 32½ years, interquartile range [iQR 27-46]) with CD (n = 46) and UC (n = 4) who received adalimumab (82% induction with 160/80 and 94% maintenance with 40 mg subcutaneously biweekly) at our center and were followed up for a median of 17 months [iQR 12-21]. The Kaplan-Meier method was used to estimate skin reaction free survival (SRFS) and Fisher's exact test to examine contingency between demographic variables and outcomes. RESULTS: Sixty-two percent of all patients developed a dermatological reaction (eczema [n = 9], acne-like dermatitis [n = 9], psoriasis-like lesions [n = 6], localized erythema and swelling at injection site [n = 1], dermatitis sicca [n = 1], rosacea [n = 1], prurigo simplex [n = 1], tinea [n = 1], localized herpes simplex [n = 1], and candida [n = 1] infections) that resolved in 12% at follow-up. SRFS was 12 months [iQR 30-5]. Adalimumab was discontinued in 22% of all patients. Longer disease duration, a lower dose induction schedule, as well as concomitant use of steroids or immunosuppressants were more often associated with an unfavorable skin outcome. Skin outcomes differed significantly between patients who saw a dermatologist (P = 0.022) and/or had a dermatological intervention (P = 0.012). CONCLUSIONS: A broad spectrum of adverse cutaneous reactions occurs more frequently and later in adalimumab therapy for IBD compared with other indications. Consultation with a dermatologist is highly recommended. (Inflamm Bowel Dis 2011). PMID: 21351201 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21351201&dopt=Abstract = URL to article

Novel Sulfated Polysaccharides Disrupt Cathelicidins, Inhibit RAGE and Reduce Cutaneous Inflammation in a Mouse Model of Rosacea. PLoS One. 2011;6(2):e16658 Authors: Zhang J, Xu X, Rao NV, Argyle B, McCoard L, Rusho WJ, Kennedy TP, Prestwich GD, Krueger G Rosacea is a common disfiguring skin disease of primarily Caucasians characterized by central erythema of the face, with telangiectatic blood vessels, papules and pustules, and can produce skin thickening, especially on the nose of men, creating rhinophyma. Rosacea can also produce dry, itchy eyes with irritation of the lids, keratitis and corneal scarring. The cause of rosacea has been proposed as over-production of the cationic cathelicidin peptide LL-37. PMID: 21347371 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21347371&dopt=Abstract = URL to article

Density of Demodex folliculorum in Patients Receiving Epidermal Growth Factor Receptor Inhibitors. Dermatology. 2011 Feb 22; Authors: Gerber PA, Kukova G, Buhren BA, Homey B Background: Rosacea-like papulopustular eruptions (rash) are considered the most frequent toxicities associated with the use of inhibitors of the epidermal growth factor receptor (EGFR). Recently, evidence has been accumulating of infectious complications in patients suffering from these adverse effects. Objective: We sought to analyze the density of Demodex folliculorum (DF) in cutaneous lesions of patients presenting with EGFR-inhibitor (EGFRI)-induced rashes. Methods: This is a retrospective study of 19 adult patients presenting with EGFRI rashes. Patients were reviewed for the density of DF (Demodex density, Dd; mites per square centimeter) by standardized skin surface biopsy. Results: In our patient collective the mean Dd of 4.7/cm(2) significantly exceeded the mean Dd reported for the healthy adult population (Dd = 0.7/cm(2)). Limitations: The retrospective nature of the study. Conclusions: EGFRI patients have an increased susceptibility to DF colonization or infection, respectively. Our results support the recent concept that EGFRI may induce an impairment of antimicrobial defense mechanisms. PMID: 21346311 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21346311&dopt=Abstract = URL to article

Evaluation of the Efficacy and Tolerance of a Topical Gel With 4% Quassia Extract in the Treatment of Rosacea. J Clin Pharmacol. 2011 Feb 22; Authors: Ferrari A, Diehl C Background: There are various treatment options available for rosacea, depending on the subtype, but treatment is still generally unsatisfactory. Some studies have reported antiparasitic and anti-inflammatory properties of Quassia amara. Aim: To check the efficacy and safety of a topical gel with 4% Quassia amara extract in the treatment of various grades of rosacea. Methods: A group of 30 patients with various grades of rosacea (I-IV) were investigated in a single-center, open-label study. They were treated with a topical gel with 4% Quassia amara extract for 6 weeks. Response was evaluated by the flushing, erythema, telangiectasia, papules, and pustules scores. At the end of therapy, overall improvement, safety, and tolerability were assessed. Results: Twenty-seven of 30 patients (90%) completed the study. The treatment resulted to be very effective, and the results achieved were in line with those published with topical metronidazole and azelaic acid. Safety and tolerability were excellent. Conclusion: Topical quassia extract could be a new, efficient, and safe weapon in the armamentarium for the management of rosacea.). PMID: 21343346 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21343346&dopt=Abstract = URL to article

Clinical Inquiries: What is the most effective treatment for acne rosacea? J Fam Pract. 2011 Feb;60(2):108a-c Authors: May D, Kelsberg G, Safranek S Topical metronidazole and azelaic acid are equally effective for the papulopustular lesions of acne rosacea, although metronidazole is better tolerated. Oral doxycycline, tetracycline, and metronidazole are also effective, but not enough evidence exists to determine whether one is more effective than another or more effective than topical therapy. PMID: 21301648 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21301648&dopt=Abstract = URL to article

Rosacea Triggered by a Vitamin B Complex Supplement. Actas Dermosifiliogr. 2011 Feb 4; Authors: Martín JM, Pellicer Z, Bella R, Jordá E PMID: 21296310 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21296310&dopt=Abstract = URL to article

Rational management of papulopustular rosacea with concomitant facial seborrheic dermatitis: a case report. J Clin Aesthet Dermatol. 2011 Jan;4(1):40-2 Authors: McFalda WL, Roebuck HL Objective: To report a case of papulopustular rosacea with concomitant seborrheic dermatitis and discuss how signs and symptoms were ameliorated using a rational therapeutic approach. Design: Patient case report. Setting: Clinical practice. Participant: One male patient with rosacea, seborrheic dermatitis, and actinic keratoses. Measurements: Change in signs and symptoms over time. Results: Improved skin care practices and treatment with azelaic acid 15% gel twice daily in combination with low-dosage oral isotretinoin resulted in improvement in symptoms of both rosacea and seborrheic dermatitis. Conclusion: In patients with multiple skin disorders, use of medications with benefits for more than one of the skin conditions may, in some cases, reduce the overall number of medications needed, thus simplifying treatment. PMID: 21278898 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21278898&dopt=Abstract = URL to article

Rosacea in Crohn's Disease: Effect of Rifaximin. J Clin Gastroenterol. 2011 Jan 26; Authors: Weinstock LB PMID: 21278581 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21278581&dopt=Abstract = URL to article

Associated Morbidity of Blepharitis. Ophthalmology. 2011 Jan 26; Authors: Nemet AY, Vinker S, Kaiserman I OBJECTIVE:: To evaluate the prevalence of systemic medical conditions in patients with blepharitis. DESIGN:: A retrospective observational case-control study. PARTICIPANTS AND CONTROLS:: All the members who were diagnosed with blepharitis in the Central District of Clalit Health Services in Israel (years 2000-2009; n=16706) and 16706 age- and gender-matched controls randomly selected from the district members. METHODS:: Analysis of the prevalence of various ocular and systemic conditions, risk factors, age, gender, marriage status, country of origin, place of residency, and socioeconomic status. MAIN OUTCOME MEASURES:: The prevalence of any associated morbidity. RESULTS:: Demographically, a significantly higher tendency to develop blepharitis was found in populations of lower socioeconomic class, populations living in urban areas, and Ashkenazi Jews. A significant association of P<0.001 was found with some inflammatory diseases (gastritis, peptic ulcer, asthma, arthropathy, and ulcerative colitis), psychologic conditions (anxiety, irritable bowel syndrome, neuroses, and depression), hormonal conditions (hypothyroidism and prostatic hypertrophy), cardiovascular diseases (carotid artery disease, hyperlipidemia, hypertension, and ischemic heart disease), and other eye conditions (chalazion, pterygium). The strongest associations found were between blepharitis and chalazia (odds ratio [OR] 4.7; confidence interval [CI], 3.8-5.7), rosacea (OR 3; CI, 2.1-4.3), pterygia (OR 2.0; CI, 1.5-2.6), ulcerative colitis (OR 2.3; CI, 1.2-4.2), irritable bowel syndrome (OR 1.8; CI, 1.3-2.5), anxiety (OR 1.6; CI, 1.4-1.9), and gastritis (OR 1.6; CI, 1.4-1.7). CONCLUSIONS:: Some ocular and systemic conditions are more prevalent among patients with blepharitis. Better understanding of the pathophysiologic association between those diseases and blepharitis may help in its treatment and prevention. FINANCIAL DISCLOSURE(S):: The author(s) have no proprietary or commercial interest in any materials discussed in this article. PMID: 21276617 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21276617&dopt=Abstract = URL to article

Rosacea and its ocular manifestations. Optometry. 2011 Feb;82(2):92-103 Authors: Oltz M, Check J Rosacea is a chronic condition affecting the facial and ocular surface tissues. It is historically underdiagnosed and affects people of all ethnicities. The exact pathophysiology of rosacea is poorly understood. A variety of medical therapies are available to treat the various signs and symptoms of rosacea. Currently, there is no cure for the condition. PMID: 21276570 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21276570&dopt=Abstract = URL to article

[Rosacea-like demodicidosis and chronic blepharitis.] Ann Dermatol Venereol. 2011 Jan;138(1):30-34 Authors: Anane S, Mokni M, Beltaief O Demodicidosis is a parasitic skin disease caused by the follicle mites Demodex sp. In this article, we present a case of rosacea-like demodicidosis, discuss the clinical features of Demodex infestation in man and review their diagnosis and therapeutic modalities. A 37-year-old woman presented in our department with chronic blepharitis present for one year. On physical examination, the patient presented blepharitis and papulovesicles with fine scaling limited to the face. There was no telangectasia. The patient did not report flushing episodes or any kind of photosensitivity. A diagnosis of rosacea-like demodicidosis and Demodex blepharitis was based on the presence of numerous Demodex folliculorum in the eyelashes and scrapings of skin lesions. The patient was put on topic and oral metronidazole for 2 months and on yellow mercury ointment for 15 days. The course involved disappearance of the facial mites and complete remission without recurrence. Screening for Demodex sp is essential to establish the correct diagnosis and ensure suitable treatment. PMID: 21276458 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21276458&dopt=Abstract = URL to article

Clinical review: topical ophthalmic use of cyclosporin A. Ocul Immunol Inflamm. 2010 Oct;18(5):352-61 Authors: Utine CA, Stern M, Akpek EK Cyclosporine A (CsA) is an immunomodulatory agent that primarily inhibits the proliferation and action of T cells. Systemic CsA has been used successfully in solid organ transplantation and noninfectious uveitis. Topical CsA with various formulations has been used in the field of ocular surface diseases since early 1980s. An ophthalmic emulsion 0.05% (Restasis, Allergan, Irvine, CA), was approved by the United States Food and Drug Administration in 2003 to treat dry eye syndrome. This article aims to evaluate the peer-reviewed published scientific literature and to define well-established uses of CsA eyedrops in the field of ocular surface diseases. PMID: 20735287 [PubMed - indexed for MEDLINE] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=20735287&dopt=Abstract = URL to article

[Chronic Eyelid Oedema and Rosacea (Morbus Morbihan): Diagnostic and Therapeutic Challenges.] Klin Monbl Augenheilkd. 2011 Jan;228(1):19-24 Authors: Renieri G, Brochhausen C, Pfeiffer N, Pitz S BACKGROUND: Morbus Morbihan is a rare complication of rosacea, consisting of a persistent lymphoedema of the upper part of the face. It has typically a chronic course, unspecific histopathological findings and an extreme refractoriness to therapy. PATIENTS AND METHODS: Between February 2008 and January 2010, 5 patients with Morbus Morbihan were observed at the Department of Ophthalmology of the University Medical Centre Mainz. In the present cohort study, we describe the clinical, laboratory and histological findings that led to the diagnosis. The course of the affection and the results of different therapeutic options are also reported. RESULTS: Each patient underwent a complete ophthalmological examination, as well as general and dermatological consultations. All patients showed facial skin alterations typical for rosacea. 4 out of 5 subjects underwent a lid biopsy to confirm the diagnosis of Morbus Morbihan, one patient refused it. Initial treatment consisted of various systemic and local medical therapies, however, with poor success. One patient had intravenous therapy with corticosteroids elsewhere with no effect. We treated 3 cases with intralesional triamcinolone injections with good results. 2 patients underwent upper lid blepharoplasty. Results of surgery remained stable also due to manual lymph drainage and intralesional injections of triamcinolon. No complications or side effects were seen in patients treated with triamcinolone. CONCLUSIONS: Morbus Morbihan can be diagnosed only after excluding other conditions leading to chronic lid swelling. In our series, good results were achieved with intralesional injection of triamcinolone. Surgery also led to relevant improvements for a long period (13 months), with some adjuvant therapy. The treatment of chronic eyelid oedema associated with rosacea remains a challenge for the ophthalmologist and the oculoplastic surgeon. PMID: 21249610 [PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21249610&dopt=Abstract = URL to article

Treatment options for rosacea with concomitant conditions. Nurse Pract. 2011 Feb;36(2):31-2 Authors: PMID: 21245721 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21245721&dopt=Abstract = URL to article

Neurogenic rosacea: a distinct clinical subtype requiring a modified approach to treatment. Arch Dermatol. 2011 Jan;147(1):123-6 Authors: Scharschmidt TC, Yost JM, Truong SV, Steinhoff M, Wang KC, Berger TG PMID: 21242409 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21242409&dopt=Abstract = URL to article

A community-based study of the effectiveness of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) on quality of life and satisfaction with treatment in participants with rosacea. Cutis. 2010 Nov;86(5 Suppl):26-36 Authors: Baldwin HE Changes to the skin of the face in patients with rosacea have the potential to substantially impair multiple domains of quality of life (QOL); however, the number of publications providing evidence for this topic is limited. This 12-week, open-label, community-based, phase 4 trial of 1421 participants is the largest study of the disease to date. It explores the effects of mild to severe rosacea and its treatment on QOL. Participants were treated with doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) as monotherapy or add-on treatment to existing topical therapy. This article examines QOL issues in the primary analysis population consisting of 966 participants who completed the trial without a major protocol violation. Quality of life was assessed at baseline and study end (week 12) with the RosaQoL, a validated 21-question instrument. Participant and investigator satisfaction with treatment also were evaluated. In the monotherapy group, the mean RosaQoL score was 3.3 at baseline and 2.8 at end of study. In the add-on therapy group, the mean RosaQoL score was 3.2 at baseline and 2.8 at end of study. The improvement in QOL was both clinically and statistically significant (P < .0001) and was similar in both monotherapy and add-on therapy groups. Most participants expressed satisfaction with treatment and approximately 90% of the community-based investigators reported that they were likely or very likely to continue prescribing this formulation. The study demonstrates that the impaired QOL in patients with rosacea can be substantially improved during a 3-month period by once-daily treatment with the anti-inflammatory activity of subantimicrobial-dose doxycycline. PMID: 21229828 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21229828&dopt=Abstract = URL to article

Effectiveness and safety of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) once daily as add-on therapy to existing topical regimens for the treatment of papulopustular rosacea: results from a community-based trial. Cutis. 2010 Nov;86(5 Suppl):16-25 Authors: Del Rosso JQ Rosacea is a prevalent inflammatory skin disorder that affects approximately 16 million individuals in the United States. Although its exact etiology is unknown, basic science, histologic evidence, and clinical evidence suggest that it is inflammatory in nature. In this 12-week, open-label, multicenter, community-based, phase 4 trial, we evaluated the anti-inflammatory effects of once daily subantimicrobial-dose doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) in participants with papulopustular rosacea (PPR) who were receiving topical therapy (metronidazole, azelaic acid, and/ or sodium sulfacetamide-sulfur) at the time of the study entry but whose rosacea symptoms were still present. The primary outcome measure was the change in the investigator global assessment (IGA) score from baseline to end of study (week 12). Secondary outcome measures were changes from baseline to end of study in the clinician erythema assessment (CEA) score, treatment responders (IGA score of clear, near clear), and safety. After week 12, 75.7% of participants in the per-protocol (PP) population had IGA scores of clear or near clear. In addition, there were significant differences in the distribution of baseline and week 12 IGA scores in the PP group (P = .0012). At week 12, most participants (63.6%) had mild CEA scores; the distribution was significantly different from baseline (P = .0407). Only 7% of participants had treatment-related adverse events (AEs), mostly mild or moderate in severity. Thus the 40-mg formulation of doxycycline proved to be effective and well-tolerated in a real-world setting in participants with rosacea who were receiving topical therapy but still experiencing symptoms. PMID: 21229827 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21229827&dopt=Abstract = URL to article

An open-label, community-based, 12-week assessment of the effectiveness and safety of monotherapy with doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads). Cutis. 2010 Nov;86(5 Suppl):7-15 Authors: Webster GF Rosacea is a common inflammatory disorder of the skin of middle-aged and older adults. A unique 40-mg formulation of doxycycline (30-mg immediate-release and 10-mg delayed-release beads) developed for its anti-inflammatory properties is the only US Food and Drug Administration-approved oral medication for the disorder. This report describes the results of the Oracea for Rosacea: A Community-Based Assessment (ORCA) trial, a phase 4 trial of the 40-mg formulation as monotherapy in adults with mild to severe papulopustular rosacea. A total of 1197 participants were enrolled in the monotherapy arm of the 12-week open-label study at 271 community-based investigational sites. The primary outcome measure was a change in the 5-point investigator global assessment (IGA) score from baseline to end point (week 12). Secondary outcome measures included change in the 5-point clinician erythema assessment (CEA) score from baseline to end point, IGA success, and adverse events (AEs). The monotherapy per-protocol (PP) population was selected a priori as the primary analysis population and safety assessments were performed on all participants who received at least 1 dose of the study drug. In the PP population of 826 monotherapy participants who completed the trial, approximately 75% of participants with mild to severe rosacea at baseline were clear or near clear by week 12, according to IGA scores. Furthermore, approximately 75% of participants had CEA scores reflecting none or mild erythema after 12 weeks. In the safety population of 1196 participants, treatment-related AEs were reported in 6.7% of participants that were mainly mild or moderate in severity. Adverse events that occurred in more than 1% of the safety population included diarrhea (1.2%), nausea (1.3%), and headache (1.0%). The incidence of fungal and yeast infections was 0.4%. The results of the ORCA trial support the effectiveness and safety of the 40-mg formulation of doxycycline in patients with papulopustular rosacea. PMID: 21229826 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21229826&dopt=Abstract = URL to article

The ORCA (Oracea for rosacea: a community-based assessment) trial: a large-scale, phase 4 trial in papulopustular rosacea. Cutis. 2010 Nov;86(5 Suppl):4-6 Authors: Del Rosso JQ PMID: 21229825 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=21229825&dopt=Abstract = URL to article