Combination Gel and Vascular ND in Mild to Moderate Rosacea
RosaceaThis is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects will be screened for study enrollment and topical treatment of their rosacea at the Screening/Baseline visit. All subjects will receive Finacea 15% gel and will be instructed to apply the study drug to one half of the face, twice daily. Drug application will be modified just prior to and after the subjects' laser treatment to reduce irritation. Subjects will undergo Vascular Nd:Yag laser therapy to involved areas over the whole face two weeks after initiating Finacea treatment. Subjects will continue to use Finacea gel to one half of the face for the duration of the study.
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
Papulopustular RosaceaTo assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.
Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea
Ocular RosaceaDry EyeDry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long term improvement of symptoms for patients by improving the quality of meibum, increasing meibum flow, improving tear film stability and decreasing inflammation. Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers, intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses, among other. Despite this variety of symptoms, patients often do not experience complete or long term relief of symptoms. Forced meibomian gland expression (MGX) has been shown to be an effective method of rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are forcefully compressed to express gland contents. Research has shown improvement in patient symptoms with the use of MGX. Intense pulsed light (IPL) have been used in dermatology to treat various conditions. Patients with DED who have tried other therapies and found no relief, often resort to IPL as a last resort. Research has shown IPL alone may be effective in improving patient symptoms. In addition, such studies have failed to show significant adverse events with the use of IPL. Here, we propose a prospective, randomized, case controlled clinical pilot study to examine the efficacy for both subjective and objective measures. 20 patients with DED will be recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL. Objective measures will include tear cytokine levels, impression cytology, meibography, tear osmolarity and others. Subjective measures will include quality of life screening tools. We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective dry eye symptoms and objective measures. Given the lack of adverse effects reported in the literature, we do not anticipate adverse effects in our study. Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no contact with subjects or biospecimens.
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of...
Papulopustular RosaceaThe primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.
A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants...
RosaceaThe objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehicle.
A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in...
Facial Papulopustular RosaceaThe primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea
RosaceaThis is a multicenter, randomized, double-blind, vehicle-controlled, parallel design study evaluating the efficacy and safety of CGB-400 Topical Gel for the treatment of inflammatory lesions of rosacea. The study consists of a 12-week double-blind treatment period with clinic visits at Baseline (Day 0), and Weeks 2, 4, 8, and 12. Approximately 80 subjects will be enrolled and randomized at a 1:1 ratio to treatment with either CGB-400 Topical Gel (40%) BID or Vehicle Gel BID.
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Papulopustular RosaceaAssessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel. Assessment of safety after repeated skin application.
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
RosaceaThe purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.
Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated...
RosaceaThe purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.