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Anti-parasitic agent
Clinical Endpoint Study of Ivermectin 1% Cream
Phase 3
Waitlist Available
Research Sponsored by Actavis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Summary
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.
Eligible Conditions
- Rosacea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent Change From Baseline to Week 12 in the Number of Inflamed (Papules/Pustules) Lesions of Rosacea.
Secondary study objectives
The Percentage of Patients With a Clinical Response of "Success".
Side effects data
From 2016 Phase 3 trial • 630 Patients • NCT028404611%
Application site pain
1%
Nasopharyngitis
1%
Headache
1%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ivermectin Cream, 1%
SoolantraTM (Ivermectin) Cream, 1%
Placebo/Vehicle Cream
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Ivermectin Cream, 1%Experimental Treatment1 Intervention
test product, manufactured by Actavis Laboratories UT, Inc.
Group II: SoolantraTM (ivermectin) Cream, 1%Active Control1 Intervention
reference product, manufactured by Galderma Laboratories, L.P.
Group III: Placebo/Vehicle creamPlacebo Group1 Intervention
Placebo, manufactured by Actavis Laboratories UT, Inc.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivermectin
FDA approved
Find a Location
Who is running the clinical trial?
Actavis Inc.Lead Sponsor
98 Previous Clinical Trials
24,617 Total Patients Enrolled
4 Trials studying Rosacea
3,500 Patients Enrolled for Rosacea