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To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea

NCT03689010 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1116

Last updated 2019-03-19

No results posted yet for this study

Summary

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.

Conditions

  • Rosacea

Interventions

DRUG

Azelaic acid foam 15%

Azelaic acid foam 15%

DRUG

Finacea® (Azelaic acid Foam) 15%

Azelaic acid foam 15%

DRUG

Vehicle of the test product

Vehicle of the test product

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Natalie Yantovskiy · Taro Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2018-08-09
Completion
2018-09-28
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 NCT03689010 on ClinicalTrials.gov