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Bioequivalence Study of Ivermectin Cream 1% in Treatment of Moderate to Severe Facial Rosacea

NCT04106726 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2020-10-14

No results posted yet for this study

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.

Conditions

  • Facial Rosacea

Interventions

DRUG

Soolantra® Ivermectin cream 1%

Apply topically to the face once daily for 84 consecutive days.

DRUG

Ivermectin cream 1%

Apply topically to the face once daily for 84 consecutive days.

DRUG

Placebo for Ivermectin cream 1%

Apply topically to the face once daily for 84 consecutive days.

Sponsors & Collaborators

  • Catawba Research, LLC

    collaborator UNKNOWN

  • Zydus Worldwide DMCC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2020-08-04
Completion
2020-08-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106726 on ClinicalTrials.gov