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NCT03689010 Clinical Trial

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

Rosacea Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03689010
Other study ID # AZAF-1703
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 12, 2017
Est. completion date September 28, 2018

Study information
Verified date March 2019
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 1116
Est. completion date September 28, 2018
Est. primary completion date August 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Azelaic acid foam 15%
Azelaic acid foam 15%
• Finacea® (Azelaic acid Foam) 15%
Azelaic acid foam 15%
• Vehicle of the test product
Vehicle of the test product

Locations
Country Name City State
United States Catawba Research, LLC Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in the inflammatory lesion counts Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts 12 weeks
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