Sun Pharmaceutical Industries, Inc.
Hawthorne, New York, 10532, United States
NCT Number: NCT07795567
The goal of this clinical trial is to evaluate and demonstrate the therapeutic equivalence and safety of Ivermectin Cream 1%, Soolantra™ Cream 1%, PrRosiver® Cream 1% & to Placebo for the treatment of moderate to severe facial rosacea.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Hawthorne, New York, 10532, United States
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ivermectin Cream 1%, to Soolantra™ Cream 1%, PrRosiver® Cream 1% & to Placebo for the treatment of moderate to severe facial rosacea.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Other names: Test Product
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Other names: Reference Product
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Other names: Reference Product
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Other names: Vehicle of the test product
Time frame: Baseline to Week 12
Percent change in the inflammatory (papules and pustules) lesion counts
Sun Pharmaceutical Industries, Inc.
Industry
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Ivermectin Cream 1% (Taro Pharmaceutical Industries, Inc.) To Soolantra™ Cream 1% (US Reference Listed Drug), PrRosiver® Cream 1% (Canadian Reference Product), and Each Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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