Clinical Endpoint Study of Ivermectin 1% Cream
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|ClinicalTrials.gov Identifier: NCT02840461|
Recruitment Status : Completed
First Posted : July 21, 2016
Results First Posted : June 2, 2020
Last Update Posted : June 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Moderate to Severe Papulopustular Rosacea||Drug: Ivermectin Cream, 1% Drug: Placebo/Vehicle cream||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||630 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (Ivermectin) Cream 1% (Galderma) in the Treatment of Moderate to Severe Papulopustular Rosacea|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Ivermectin Cream, 1%
test product, manufactured by Actavis Laboratories UT, Inc.
Drug: Ivermectin Cream, 1%
Active Comparator: SoolantraTM (ivermectin) Cream, 1%
reference product, manufactured by Galderma Laboratories, L.P.
Drug: Ivermectin Cream, 1%
Placebo Comparator: Placebo/Vehicle cream
Placebo, manufactured by Actavis Laboratories UT, Inc.
Drug: Placebo/Vehicle cream
- Percent Change From Baseline to Week 12 in the Number of Inflamed (Papules/Pustules) Lesions of Rosacea. [ Time Frame: Baseline and 12 Weeks ]Bioequivalence of the test to reference was considered to have been demonstrated if the 90% confidence interval for the test to reference ratio for the percent change from baseline to Week 12 in the number of inflamed lesion counts was within [80%, 125%].
- The Percentage of Patients With a Clinical Response of "Success". [ Time Frame: Baseline to Week 12 ]The secondary endpoint was the percentage of patients with a clinical response of "success" using the IGE at Week 12. At Visit 1, the IGE had to be 3 or 4 for the patient to be eligible for inclusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840461
|United States, Illinois|
|Investigator site 1|
|Arlington Heights, Illinois, United States, 60005|