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CLINICAL TRIALS PROFILE FOR MIRVASO

Clinical Trials for Mirvaso

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02249065	Mirvaso in Use Study	Completed	Galderma Laboratories, L.P.	Phase 4	This study is designed to: 1. assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel 2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment 3. gain a better understanding of the real-world use ofMirvaso® on the pattern and management of facial erythema of rosacea.
NCT02289352	Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea	Completed	Watson Laboratories, Inc.	Phase 3	A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema Associated with Rosacea
NCT02289352	Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea	Completed	Actavis Inc.	Phase 3	A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema Associated with Rosacea
NCT02616250	MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.	Active, not recruiting	Galderma	Phase 4	The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.
NCT02659670	Internet Surveys and Their Impact on Adherence to Brimonidine Topical Gel and QOL in Patients With Rosacea	Recruiting	Wake Forest University Health Sciences	Phase 4	An investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. Adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine. Subjects with persistent erythema associated with rosacea will be recruited from the Wake Forest Baptist Health Dermatology Clinics and IRB approved advertising. At the baseline screening visit, subjects will have the diagnosis of rosacea confirmed by an investigator. Subjects will be classified as having erythematotelangiectatic or a combination erythematotelangiectatic and papulopustular. Study staff will evaluate whether subjects believe they have constant erythema or more intermittent flushing and blushing. Subjects will be informed of the benefits and risks of treatment. If they agree to participate, the subjects will give written consent approved by the Institutional Review Board and will be seen in follow up at 3 months and 6 months. Subjects will be randomized 1:1 to be in the weekly internet survey group or the standard care non-survey group. The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. Subjects will be asked a variety of questions during the weekly internet survey; such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication. Subjects in the non-internet survey group will just get these identical surveys at the Month 3 and Month 6 visits. The Investigator is also interested in learning through the adherence surveys if subjects begin using the medication on an as needed basis, and if this affects the side effect profile and satisfaction with the medication.
NCT02761174	Topical Brimonidine to Reduce Inflammation After IPL-treatment in Patients With Facial Telangiectasias	Recruiting	Ellipse A/S Agern Allé 11, 2970 Hørsholm	Phase 4	The aim of the study is to investigate whether brimonidine cream can reduce IPL-induced inflammation in terms of redness, swelling and pain in patients with facial vascular lesions (telangiectasias). Furthermore, the effect of brimonidine cream on IPL-efficacy is evaluated one month after final IPL-treatment. The hypothesis is that brimonidine, which has been proved effective in reduction of symptomatic erythema in patients with rosacea, also may have the ability to reduce IPL-induced erythema. Since the potential reduction in erythema is caused by vasoconstriction, brimonidine may further reduce IPL-induced oedema and pain.
NCT02761174	Topical Brimonidine to Reduce Inflammation After IPL-treatment in Patients With Facial Telangiectasias	Recruiting	Skinperium, Christine Dierickx	Phase 4	The aim of the study is to investigate whether brimonidine cream can reduce IPL-induced inflammation in terms of redness, swelling and pain in patients with facial vascular lesions (telangiectasias). Furthermore, the effect of brimonidine cream on IPL-efficacy is evaluated one month after final IPL-treatment. The hypothesis is that brimonidine, which has been proved effective in reduction of symptomatic erythema in patients with rosacea, also may have the ability to reduce IPL-induced erythema. Since the potential reduction in erythema is caused by vasoconstriction, brimonidine may further reduce IPL-induced oedema and pain.
Trial ID	Title	Status	Sponsor	Phase	Summary