check_circleStudy Completed

Papulopustular Rosacea

Bayer Identifier:

15386

ClinicalTrials.gov Identifier:

NCT01257919

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - diagnosis of moderate papulopustular rosacea
    - free of any clinically significant disease
  • - body weight less than 50 or more than 130 kg
    - clinically significant disease which could interfere with the study

Trial summary

Enrollment Goal
21
Trial Dates
January 2011 - March 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Novum Pharmaceutical Research Services of Nevada Inc.Las Vegas, 89121, United States

Primary Outcome

  • Baseline corrected area under the curve (AUC)
    date_rangeTime Frame:
    12 hours
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    Safety Issue:
    No

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

Additional Information

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