A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea
A Phase 2, Multi-Center, Evaluator-Blind, Randomized, Vehicle-Controlled Clinical Study to Assess the Safety and Efficacy of IDP-115 in the Treatment of Rosacea
1 other identifier
interventional
140
1 country
10
Brief Summary
The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2007
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFebruary 20, 2012
February 1, 2012
8 months
April 23, 2008
February 16, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in the number of inflammatory lesions
12 weeks
Improvement from baseline in global severity
12 weeks
Secondary Outcomes (1)
Change from baseline in erythema
12 weeks
Study Arms (3)
1
EXPERIMENTAL2
PLACEBO COMPARATOR3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Presence of facial rosacea
- Presence of inflammatory lesions
You may not qualify if:
- Dermatological conditions of the face that could interfere with clinical evaluations
- Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption)
- Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Solano Clinical Research
Vallejo, California, 94589, United States
Cherry Creek Dermatology Research Inc.
Denver, Colorado, 80246, United States
FXM Research Corp.
Miami, Florida, 33175, United States
MedaPhase Inc.
Newnan, Georgia, 30263, United States
Henry Ford Medical Center
Detroit, Michigan, 48202, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
University Dermatology Consultants, Inc.
Cincinnati, Ohio, 45219, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 25, 2008
Study Start
November 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
February 20, 2012
Record last verified: 2012-02