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CLINICAL TRIALS PROFILE FOR MIRVASO
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All Clinical Trials for Mirvaso
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02249065 | Mirvaso in Use Study | Completed | Galderma Laboratories, L.P. | Phase 4 | 2014-09-01 | 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 | 2014-07-01 | 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 | 2014-07-01 | 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 | 2015-12-01 | 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 | 2016-01-01 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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