CLINICAL TRIALS PROFILE FOR SOOLANTRA
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All Clinical Trials for Soolantra
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01493947 ↗ | CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study | Completed | Galderma R&D | Phase 3 | 2012-04-01 | Study objectives: - To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment. - And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment |
| NCT02616250 ↗ | MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea. | Completed | 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. |
| NCT02616250 ↗ | MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea. | Completed | Galderma R&D | 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. |
| NCT02806414 ↗ | Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation. | Completed | Galderma | Phase 1/Phase 2 | 2016-07-01 | This study will assess the role of topical Ivermectin 1% cream and its effect on protease and antimicrobial peptide expression and on the skin microbiome (the microorganisms that live on the skin) in rosacea. This is a single-site 16-week open-label study at University of California, San Diego. The investigators will do this by first measuring serine protease activity and cathelicidin and skin microbiome of all subjects. All subjects will receive Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks. Participants will return for monthly visits during which their clinical symptoms of facial redness and number of facial papules will be scored, and they will have repeat tape stripping and/or skin swabs. At the end of the study, tape strips and skin swabs will be analyzed to determine serine protease activity and skin microbiome of participants at each of their visits and expression of cathelicidin (LL-37) mRNA. The investigators will then look at changes in serine protease activity and LL-37 expression and skin microbiome over time, and they will also determine whether or not these changes correlate with disease severity. |
| NCT02806414 ↗ | Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation. | Completed | Galderma R&D | Phase 1/Phase 2 | 2016-07-01 | This study will assess the role of topical Ivermectin 1% cream and its effect on protease and antimicrobial peptide expression and on the skin microbiome (the microorganisms that live on the skin) in rosacea. This is a single-site 16-week open-label study at University of California, San Diego. The investigators will do this by first measuring serine protease activity and cathelicidin and skin microbiome of all subjects. All subjects will receive Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks. Participants will return for monthly visits during which their clinical symptoms of facial redness and number of facial papules will be scored, and they will have repeat tape stripping and/or skin swabs. At the end of the study, tape strips and skin swabs will be analyzed to determine serine protease activity and skin microbiome of participants at each of their visits and expression of cathelicidin (LL-37) mRNA. The investigators will then look at changes in serine protease activity and LL-37 expression and skin microbiome over time, and they will also determine whether or not these changes correlate with disease severity. |
| NCT02806414 ↗ | Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation. | Completed | University of California, San Diego | Phase 1/Phase 2 | 2016-07-01 | This study will assess the role of topical Ivermectin 1% cream and its effect on protease and antimicrobial peptide expression and on the skin microbiome (the microorganisms that live on the skin) in rosacea. This is a single-site 16-week open-label study at University of California, San Diego. The investigators will do this by first measuring serine protease activity and cathelicidin and skin microbiome of all subjects. All subjects will receive Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks. Participants will return for monthly visits during which their clinical symptoms of facial redness and number of facial papules will be scored, and they will have repeat tape stripping and/or skin swabs. At the end of the study, tape strips and skin swabs will be analyzed to determine serine protease activity and skin microbiome of participants at each of their visits and expression of cathelicidin (LL-37) mRNA. The investigators will then look at changes in serine protease activity and LL-37 expression and skin microbiome over time, and they will also determine whether or not these changes correlate with disease severity. |
| NCT03075891 ↗ | Oracea Soolantra Association in Participants With Severe Rosacea | Completed | Galderma | Phase 4 | 2017-07-05 | The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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