Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea
2 other identifiers
interventional
21
1 country
1
Brief Summary
Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel. Assessment of safety after repeated skin application.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2011
Shorter than P25 for phase_1
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
First Submitted
Initial submission to the registry
December 9, 2010
CompletedFirst Posted
Study publicly available on registry
December 10, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 9, 2023
February 1, 2014
2 months
December 9, 2010
June 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Baseline corrected area under the curve (AUC)
12 hours
Study Arms (2)
Azelaic Acid Foam 15%
EXPERIMENTALDermal application of Azelaic Acid Foam 15%
Azelaic Acid Gel 15%
ACTIVE COMPARATORDermal application of Azelaic Acid Gel 15%
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of moderate papulopustular rosacea
- free of any clinically significant disease
You may not qualify if:
- body weight less than 50 or more than 130 kg
- clinically significant disease which could interfere with the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
- Bayercollaborator
Study Sites (1)
Novum Pharmaceutical Research Services of Nevada Inc.
Las Vegas, Nevada, 89121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2010
First Posted
December 10, 2010
Study Start
January 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 9, 2023
Record last verified: 2014-02