Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Papulopustular Rosacea
Intervention: Azelaic Acid Foam (Drug); Azelaic Acid Gel (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Baseline corrected area under the curve (AUC)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- diagnosis of moderate papulopustular rosacea
- free of any clinically significant disease
Exclusion Criteria:
- body weight less than 50 or more than 130 kg
- clinically significant disease which could interfere with the study
Locations and Contacts
Novum Pharmaceutical Research Services of Nevada Inc., Las Vegas, Nevada 89121, United States
Additional Information
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Starting date: January 2011
Last updated: February 19, 2014
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