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A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea

NCT03287791 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 924

Last updated 2019-07-31

Study results available
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Summary

The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehicle.

Conditions

  • Rosacea

Interventions

DRUG

Generic Azelaic Acid Foam

Topical foam, generic formulation of the brand product.

DRUG

Finacea® (Azelaic Acid) Foam

Topical foam, brand product.

DRUG

Vehicle Foam

Topical foam, placebo. Has no active ingredient.

OTHER

Cleanser

A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.

OTHER

Sunscreen

Sunscreen provided to participants, so they can apply it to their face when outdoors.

OTHER

Towel

A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.

OTHER

Moisturizing Lotion

Moisturizing lotion provided to participants, so they can apply it to their face, as needed.

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Teva Pharmaceuticals USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-19
Primary Completion
2017-06-22
Completion
2017-06-22
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 NCT03287791 on ClinicalTrials.gov