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OpenTrials
Completed

NCT Number: NCT03689010

To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial 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 facial rosacea.

Completed

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Catawba Research, LLC

Charlotte, North Carolina, 28217, United States

About this study

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea.
  • Subjects must have provided IRB approved written informed consent.

Exclusion criteria

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
  • Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.

Treatment and study plan

Azelaic Acid foam 15%

Drug

Azelaic acid foam 15%

Other names: AZAF 1703

Finacea® (Azelaic acid Foam) 15%

Drug

Azelaic acid foam 15%

Vehicle of the Test product

Drug

Vehicle of the test product

Other names: Placebo

Primary outcomes

  1. change in the inflammatory lesion counts

    Time frame: 12 weeks

    Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Taro Product to RLD, and Both Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 28, 2018
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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