To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea
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
1 other identifier
interventional
1,116
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2018
CompletedFirst Submitted
Initial submission to the registry
September 21, 2018
CompletedFirst Posted
Study publicly available on registry
September 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2018
CompletedMarch 19, 2019
March 1, 2019
8 months
September 21, 2018
March 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
change in the inflammatory lesion counts
Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts
12 weeks
Study Arms (3)
Azelaic acid foam 15%
ACTIVE COMPARATORTopical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
Finacea® (azelaic acid) Foam, 15%
ACTIVE COMPARATORTopical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
Vehicle of the test product
PLACEBO COMPARATORTopical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
Interventions
Vehicle of the test product
Eligibility Criteria
You may qualify if:
- Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea.
- Subjects must have provided IRB approved written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catawba Research, LLC
Charlotte, North Carolina, 28217, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Natalie Yantovskiy
Taro Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2018
First Posted
September 28, 2018
Study Start
December 12, 2017
Primary Completion
August 9, 2018
Study Completion
September 28, 2018
Last Updated
March 19, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share