Rosacea: Metronidazole Plus Modified Release 40 Mg Doxycycline Improved Moderate To Severe Disease

dr-warren-winkelmanMedicalResearch.com Interview with: 
Warren J. Winkelman, MD, MBA, PhD, FRCPC, FAAD
Director, Medical Affairs
Galderma Laboratories, L.P.
Fort Worth TX 76177

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Winkelman: Rosacea is a common dermatologic facial disorder estimated to affect 16 million Americans. Rosacea is a chronic condition of the central face, including the nose, chin, cheeks and forehead, and is often characterized by flare-ups and remissions. While the cause of rosacea is unknown and there is no cure, its signs and symptoms can become markedly worse in the absence of treatment. Rosacea can be managed with topical and oral medications, and physicians often resort to using these medications in combination for more severe or resistant cases. Doxycycline 40 mg modified release (MR) and metronidazole 1% gel are FDA-approved oral and topical therapies, respectively, indicated to treat the papules and pustules of rosacea. We conducted a phase 2 study to assess the relapse rate, efficacy, and safety of doxycycline 40 mg MR compared to placebo after an initial 12-week once-daily combination regimen of doxycycline 40 mg MR and metronidazole 1% gel in subjects with moderate to severe disease.

Of the 235 subjects enrolled in the study, 71% were women, 94% were white, and 75% had Fitzpatrick skin type I, II or III. The mean age was 47.4 years. The percentage of subjects who achieved a success score of 0 (clear) or 1 (near clear) improved from 0% at baseline to 51% at week 12. Clinician’s erythema assessment scores, inflammatory lesion counts, and quality of life scores also improved. Most subjects reported no or mild scaling, stinging/burning, and dryness. Five adverse events were reported that were considered probably or definitely related to treatment: fungal infection, vulvovaginal mycotic infection, pain in extremity, erythema, and skin exfoliation.

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Psoriasis: Effective Two Year Response to IL-17A Antagonist Cosentyx

Andrew Blauvelt, M.D., M.B.A. President and Investigator Research Excellence & Personalized Patient Care Portland, OR 97223MedicalResearch.com Interview with:
Andrew Blauvelt, M.D., M.B.A.
President and Investigator
Research Excellence & Personalized Patient Care
Portland, OR 97223

Medical Research: What is the background for this study? What are the main findings?

Dr. Blauvelt: A2303E1 is a multicenter, double-blind, randomized withdrawal extension to the FIXTURE and ERASURE pivotal phase III studies.  The purpose of this extension study was to collect additional long term efficacy, safety, and tolerability data on secukinumab (i.e., Cosentyx) in patients who demonstrated a PASI 75 response to Cosentyx at Week 52 of these core studies in moderate-to-severe plaque psoriasis.

In the extension phase, 995 patients who achieved Psoriasis Area Severity Index (PASI) 75 responses after 52 weeks of therapy received either Cosentyx 300 mg, Cosentyx 150 mg, or placebo for an additional year (Week 104).  After two full years of therapy in patients treated with Cosentyx 300 mg, almost 9 out of 10 (88.2%) patients maintained their PASI 75 response, 7 out of 10 (70.6%) had clear or almost clear skin (PASI 90), and 4 out of 10 (43.9) had clear skin (PASI 100) at Week 104.  For patients treated with Cosentyx 150 mg, 75.5% maintained their PASI 75 response, 44.6% had clear or almost clear skin (PASI 90), and 23.5% had clear skin (PASI 100) at Week 104.  In addition, 94.8% of patients who initially received placebo (at the start of the extension), and were switched to receive Cosentyx 300 mg after relapse, were able to achieve PASI 75 and 70.3% achieved PASI 90 within 12 weeks of re-starting Cosentyx. Continue reading

More Asians and Hispanics Developing Non-Melanoma Skin Cancer

MedicalResearch.com Interview with:
Arisa Ortiz, MD, FAAD Assistant Clinical Professor
Director, Laser and Cosmetic Dermatology
Senior author: Brian Jiang, MD and
First author Tiffany Loh, BS
Department of Dermatology UC San Diego

Medical Research: What is the background for this study? What are the main findings?

Response: Non-melanoma skin cancers (NMSCs) are the most common type of malignancy in the United States, affecting an estimated 3.5 million people each year. Previous perception has remained that skin cancer risk in Hispanics and Asians is lower than that of Caucasians. However, despite historically lower rates of skin cancer, in recent years, the incidence of skin cancer in these groups has reportedly been increasing in the United States. As Hispanics and Asians constitute two of the most rapidly expanding ethnic groups in the US, the rise in NMSCs in these populations is particularly concerning.

The finding from our study were as follows: Hispanic patients were significantly younger than Caucasians and Asians (p=0.003, 0.023 respectively). The majority of Non-melanoma skin cancers in Caucasians occurred in men, while this gender ratio was reversed for both Hispanics and Asians. There were significantly more cases of Non-melanoma skin cancers occurring in the “central face” area in Hispanics. Race was not a significant predictor for specific NMSC type (BCC or SCC).

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Opioid Analgesics Prescribed In Patients With Skin Disorders and Psychiatric Diagnoses

Madhulika A. Gupta MD  University of Western OntarioMedicalResearch.com Interview with:
Madhulika A. Gupta MD 
University of Western Ontario

Medical Research: What is the background for this study? What are the main findings?

Dr. Gupta: Opioid (narcotic) analgesics (OA) are FDA-approved primarily for the symptomatic relief of pain in acute and chronic conditions. The prescription rates of Opioid analgesics in the US have increased significantly since 1989, and their possible inappropriate use has been declared a public health concern. We have recently reported (GuptaMA et al. J Dermatol Treat, 2014) that the use of Opioid analgesics in primarily skin disorders (with no reported non-dermatologic comorbidities) has increased from 1995-2010. Skin disorders are associated with psychiatric pathology in up to 30% of cases. Psychiatric disorders have been associated with an increased use of Opioid analgesics and other potentially addictive drugs. We examined psychiatric disorders, comorbidities and psychotropic drugs in patient visits with skin disorders and Opioid analgesics use (‘Skin Disorders+OA’).

We examined nationally representative cross-sectional data collected between 1995-2010 by the NAMCS and NHAMCS. Up to 3 ICD9-CM diagnoses are coded for each patient visit; the following codes were used to create the ‘Skin Disorders’ variable: ICD9-CM codes 680-709 ‘Diseases of the Skin and Subcutaneous Tissue’ and ICD9-CM codes 172, 173, 216 and 232 for cutaneous malignancies. Ambulatory Care Drug Database System drug codes were used for creation of variables for Opioid analgesics and other psychotropics.

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Acne: Potassium Monitoring May Not Be Necessary For Spironolactone Therapy

Dr. Arash Mostaghimi, MD, MPA Director of Dermatology Inpatient Service Brigham and Women’s Hospital Boston, MAMedicalResearch.com Interview with:
Dr. Arash Mostaghimi, MD, MPA

Director of Dermatology Inpatient Service
Brigham and Women’s Hospital
Boston, MA

 

 

Medical Research: What is the background for this study? What are the main findings?

Dr. Mostaghimi: Spironolactone, a generic drug that’s been used in the clinic since 1959, is commonly prescribed for treating hormonal acne – acne that tends to affect the jaw line most commonly around the time of the month when a woman gets her period. The US Food and Drug Administration recommends frequent potassium monitoring in patients with heart failure who are taking spironolactone as a diuretic and antihypertensive treatment, but it’s been unclear if these guidelines should apply to healthy patients taking spironolactone for the treatment of acne, and, if so, how frequently such patients should have their potassium levels tested.

My colleagues and I have found that for young, healthy women taking spironolactone to treat hormonal acne, potassium monitoring is an unnecessary health care expense. For the approximately 1,000 patients we studied, blood tests to monitor potassium levels did not change the course of treatment, but the tests cumulatively totaled up to $80,000. We suggest that routine potassium monitoring should no longer be recommended for this patient population in order to improve the patient care experience, decrease unnecessary office visits and reduce health care spending. Continue reading