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Anti-parasitic agent

Test: Ivermectin cream 1% for Rosacea

Phase 3
Waitlist Available
Research Sponsored by Zydus Worldwide DMCC
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 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

To evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Zydus Worldwide DMCC) and Soolantra® (ivermectin) cream, 1% (Galderma Laboratories, L.P.) in the treatment of moderate to severe facial papulopustular rosacea. To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate to severe facial rosacea.

Eligible Conditions
  • Rosacea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts.
Secondary study objectives
Exploratory Endpoint: The proportion of subjects with a clinical response (IGA) of "success" at week 12.

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: Test: Ivermectin cream 1%Experimental Treatment1 Intervention
Manufactured by Zydus Worldwide DMCC; Apply cream to the affected areas of the face once daily for 12 weeks.
Group II: Reference: Soolantra® cream, 1%Active Control1 Intervention
Manufactured by Galderma Laboratories, L.P.; Apply cream to the affected areas of the face once daily for 12 weeks.
Group III: Placebo: Placebo for Ivermectin cream 1%Placebo Group1 Intervention
Manufactured by Zydus Worldwide DMCC; Apply to the affected areas of the face once daily for 12 weeks.
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?

Catawba Research, LLCUNKNOWN
1 Previous Clinical Trials
755 Total Patients Enrolled
Zydus Worldwide DMCCLead Sponsor
~87 spots leftby Oct 2025
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