Oracea® Capsules + Soolantra Cream Effective for Inflammatory Rosacea

MedicalResearch.com Interview with:

Dr. James Q. Del Rosso, D.O., FAOCD, DermatologistResearch Director and Principal InvestigatorDel Rosso Dermatology Research Center, Las Vegas, NVGalderma Consultant

Dr. Del Rosso

Dr. James Q. Del Rosso, D.O., FAOCD, Dermatologist
Research Director and Principal Investigator
Del Rosso Dermatology Research Center, Las Vegas, NV
Galderma Consultant

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

  • The ANSWER study, a 12-week, randomized, multicenter, Phase 4, Phase 3b in Canada and Europe clinical trial, is the first study of its kind to compare the efficacy and safety of combination therapy with Oracea® (doxycycline, USP) 40 mg Capsules + Soolantra® (ivermectin) Cream, 1% versus Soolantra® (ivermectin) Cream, 1% monotherapy in 273 adults with severe papulopustular rosacea (IGA 4) at clinical trial sites in the United States, Canada and Europe (Czech Republic, Poland, Hungary and Germany).
  • Results showed the combination therapy with Oracea Capsules + Soolantra Cream was well tolerated and effective with a faster onset of action than Soolantra Cream given as monotherapy. Key highlights of the study include:
  • The mean reduction in percentage of inflammatory lesions from baseline to Week 12 was significant with combination therapy compared to monotherapy (80.29% vs. 73.56%, respectively; p=0.032).
  • 5 times as many patients taking combination therapy achieved 100% clearance of inflammatory lesions by Week 12 compared with monotherapy (17.8% vs. 7.2%, respectively; p=0.006).
  • Over 2 times as many patients taking combination therapy achieved 100% clear (IGA 0) by Week 12 compared with monotherapy (11.9% vs. 5.1%, respectively; p=0.043).
  • Combination therapy was generally well tolerated and no discontinuation of treatments due to side effects.

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Rosacea May Be a Cutaneous Manifestation of Migraine

MedicalResearch.com Interview with:

Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital, University of Copenhagen Hellerup, Denmark

Dr. Alexander Egeberg

Alexander Egeberg, MD PhD
Gentofte Hospital
Department of Dermatology and Allergy
Hellerup Denmark

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

Response: Patients with rosacea frequently report symptoms of migraine, and this link has been discussed for many years. However, very little research has actually been performed in this area, and the prevalence varies greatly between studies. We examined the prevalence of migraine in patients with rosacea, nationwide, as well as the risk of new-onset migraine in patients with manifest rosacea. We found a markedly increased prevalence of migraine among patients with rosacea. The risk of new-onset migraine was also higher among patients with rosacea, but only among women. Perhaps most notably was the observation that risk of new-onset migraine was highest among patients older than 50 years. This was surprising, since new-onset migraine in older individuals is often considered a “red flag”.

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Rosacea Should Be Considered More Than Cosmetic Disorder

MedicalResearch.com Interview with:

Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital, University of Copenhagen Hellerup, Denmark

Dr. Alexander Egeberg

Alexander Egeberg, MD PhD
National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology
Herlev and Gentofte University Hospital
University of Copenhagen
Hellerup, Denmark 

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

Dr. Egeberg: Rosacea skin shows an up-regulation of various cytokines (small proteins that are important in cell signalling), and displays increased activation and expression of matrix metalloproteinases (MMPs). Both rosacea and Parkinson’s disease have been associated with small intestinal bacterial overgrowth and Helicobacter pylori infection, and MMPs. MMPs are enzymes that are involved in tissue remodeling, organ development, and regulation of inflammatory processes.

Parkinson’s is a progressive neurological disease that results from the gradual loss of brain cells that produce dopamine, a chemical that sends messages to the part of the brain that controls movement and coordination. Importantly, MMPs have also been implicated in the pathogenesis of Parkinson’s disease and other neurodegenerative disorders, and MMPs contribute to loss of dopamine producing brain cells.

Rosacea is often characterized by flare-ups and remissions and typically presents as a redness on the cheeks, nose, chin or forehead. In our study, we found a significantly (approximately two-fold) increased risk of developing Parkinson’s disease, a chronic and progressive movement disorder, among patients with rosacea. Also, we found that treatment with tetracycline, an oral antibiotic, was associated with a slightly decreased risk of Parkinson’s disease.

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Rosacea Linked To Slight Increased Risk of Glioma

Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital, University of Copenhagen Hellerup, Denmark

Dr. Alexander Egeberg

MedicalResearch.com Interview with:
Alexander Egeberg, MD PhD
National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology
Herlev and Gentofte University Hospital
University of Copenhagen
Hellerup, Denmark  

Medical Research: What is the background for this study? What are the main findings?
Dr. Egeberg: There appears to be an overlap in the pathogenesis of rosacea and glioma, focused around matrix metalloproteinases.

Rosacea may be associated with an increased risk of glioma, however, it is important to note that the absolute risk is still low. Whether this is a causal link is not known.

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Twin Study Shows Rosacea Has 50:50 Genetic and Environmental Influences

Nely Aldrich, MD Department of Dermatology University Hospitals Case Medical CenterMedicalResearch.com Interview with:
Nely Aldrich, MD
Department of Dermatology
University Hospitals Case Medical Center

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

Dr. Aldrich:   To our knowledge, no formal studies have been performed on the genetic vs. environmental factors that lead to the development of rosacea. Our department has the unique opportunity to attend the Twins Days festival in Twinsburg, Ohio. This is a yearly festival where thousands of twin pairs come from all over the world. This was the perfect setting to ask our research question. Our main finding was that there is an approximately 50% contribution of genetics to rosacea and the other 50% can be attributed to environmental factors. Sun exposure, smoking, alcohol use, skin cancer history, and heart disease were also found to be correlated with a higher rosacea severity.

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Rosacea May Be Linked To Skin and Thyroid Cancer

Wen-Qing Li Ph.D Department of Dermatology Warren Alpert Medical School Department of Epidemiology, School of Public Health, Brown University, Providence, RIMedicalResearch.com Interview with:
Wen-Qing Li Ph.D
Department of Dermatology Warren Alpert Medical School
Department of Epidemiology, School of Public Health,
Brown University, Providence, RI

Medical Research: What is the background for this study?

Response: Rosacea is a chronic inflammatory cutaneous disorder and may be an end-organ response in a systemic disorder. We systemically examined the association between personal history of rosacea and risk of cancer based on 75088 whites in the Nurses’ Health Study II, during a follow-up of 20 years.

Medical Research: What are the main findings?

Response: We suggest possible associations between personal history of rosacea and an increased risk of thyroid cancer and Basal Cell Cancer. Analyses did not find significant associations for other individual cancer types.  Continue reading

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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Rosacea Improved With Modified Release Doxycycline 40 mg Plus Topical Metronidazole

Warren J. Winkelman, MD, MBA, PhD, FRCPC, FAAD Director, Medical Affairs Galderma Laboratories, L.P. Fort Worth TXMedicalResearch.com Interview with:
Warren J. Winkelman, MD, MBA, PhD, FRCPC, FAAD

Director, Medical Affairs
Galderma Laboratories, L.P.
Fort Worth TX

MedicalResearch.com: 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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