Trial Condition(s):
Papulopustular Rosacea
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Bayer Identifier:
15386
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Novum Pharmaceutical Research Services of Nevada Inc. Las Vegas, United States, 89121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Baseline corrected area under the curve (AUC)Timeframe: 12 hours
Additional Information
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